Running head: Post-9/11 Veterans with PTSD: A battle with smoking

Proposal Paper for Post-9/11 Veterans with PTSD: A battle with smoking
Morgan Mathews and Brenda Pizana
The University of Texas at Arlington College of Nursing

In partial fulfillment of the requirements of
N5366 Principles of Research in Nursing
Dr. Michelle Hampton, PhD, RN-CCRN, Clinical Faculty
July 31, 2015

Pinch table

Author/yr Design Sample Size Interventions Outcomes Notes
Use of Learning Collaborative to Support Implementation of Integrated Care for Veterans with Posttraumatic Stress Disorder

Use of Learning Collaborative to Support Implementation of Integrated Care for Veterans with Posttraumatic Stress Disorder 2014
Longitudinal, Time series Quasi- experimental study. Methodological Research Collaborative change framework using the learning collaborative model

70 staff members from 12 VA PTSD Clinics

After training and development of a expert panel team, questionnaires evaluated how feasible and effective integrative care for smoking cessation using the Learning Collaborative Model.

The LC model would be useful to implement integrated care to patients without interfering with treatment. The staff found it useful but difficult to communicate and meet with teams to train

Unique challenges: different clinics of VA It is unknown whether the practice will continue with time. These subjects were examined at 12 and 24 months to check for continued delivery of teaching

|Implementing Smoking Cessation guidelines for hospitalized Veterans: Effects on nurse attitudes and performance |

David A. Katz, John Holman, Skyler Johnson, Stephen L. Hills, Sara Ono, Kenda Stewart, Monica Paez

2013

Quasi Experimental

Nurses felt these interventions 5a’s, brochures, pharmacotherapy, and admission database was sufficient and helpful tools for

Adult patients at or >18 years old, smokes at least one cigarette/day, hospitalized as an inpatient for at least 18 hours

Adult patients at or >18 years old, smokes at least one cigarette/day, hospitalized as an inpatient for at least 18 hours

There were no differences between those who participated and those who didn’t. The use of the 5A’s was significantly greater during the post-implementation period. Nurses had higher scores on the “pros” scale of the balance questionnaire. Patients of smoking nurses were no less likely to receive

smoking cessation

Note-limitation of study and possible
Hawthorne effect

Dissemination of the nurse-administered Tobacco Tactics intervention versus usual care in the six Trinity community hospitals

Blow, D.J., Clothier, B., Fu, S.S., Joseph, A.M., Noorbaloochi, S.,Taylor, B.C., Van Ryn, M.

2014
Design-Quasi-experimental, Time series design

Framework- Change theory

6 of 47 Hospitals in the Trinity Healthcare System, all units with Psych., ICU/CCU excluded. 18 years old at least, smoked a cigarette within one month of hospitalization, have at least a 24 hr observation, will complete questionnaire.

Control group will receive usual care.

Interventional group-nurse administered Tobacco Tactics

Data is collected pre and post intervention in control and experimental groups and at 30days and 6 months post-recruitment. Urinary test strips were returned for $20 and for each
The potential for wide reach and decreasing smoking while decreasing co-morbidities associated with smoking.

Descriptive statistics and power analysis is used to evaluate data, GEE analysis to account for correlations and ICER analysis and QUALY model to.
Extensive follow up is used to minimize missing data.

Intervention is easy to integrate into busy inpatient units.

Implementation focuses on “high reach, high effectiveness, and low cost”

survey complete $10 was compensated.

calculate cost per adjusted life

Smoking Cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial

Battaglia, C., Peterson, J., Prochazka, A.V.

2015
Design: Randomized Controlled Trial. Funded by the Veterans Affairs Research Services..

Theoretical Framework and Conceptual Model based on
Trans-Theoretical Change (TTM) and Chronic Care Model.
Target Population n=120. Selection of participants was randomized through multiple recruitment outlets. Participants randomized into a control or intervention group.

Inclusion criteria – DSM-IV diagnosis with PTSD and documented in medical recorder, 18 years or older,
Intervention group was based on receiving additional care and education regarding smoking cessation.
Group received smoking cessation education / curriculum via home telehealth buddy system and weekly MI counseling by a trained nurse.
Behavior change was assessed among
Motivational Interviewing and smoking cessation via home teleheath program has shown to increase the readiness for change and smoking cessation. This protocol integrates and overall strengthen the study by incorporating written smoking cessation curriculum and phone based MI
Health Buddy is a chronic disease management tool used by the VHA. Participants used daily to address questions regarding behavior change and smoking education.

or older, willingness to participate, and currently smoking one or more cigarettes per day.

Exclusion criteria - use smokeless tobacco

the intervention group.

Instruments- Quit attempts measured, stage of Change examined through behavior model, smoking cessation 24 hour re-call, care coordination, participant satisfaction survey, and examining PTSD symptom change measured by Geriatric Depression

counseling.
(Battaglia et al., 2015).
Program has the ability to reach veterans who live at a significant distance from tertiary care or even those who suffer deeply with PTSD.

Overall, the intervention care management is designed to alleviate and uplift barriers

Smoking Cessation Among African American and White Smokers in the Veterans Affairs Health Care System
Burgess, D.J., Clothier, B., Fu, S.S., Joseph, A.M., Noorbaloochi, S., Van Ryn, M.

2014

Experimental Randomized controlled trial examined smoking cessation intervention. Also, association between race and smoking cessation among the Veteran Affairs Health Care System.
Time Series study used to examine and determine trends among population. No specific framework

Target population inclusion criteria consisted of current smokers only, and either White or African American decent.
-Trial conduction setting took place among the Veteran Affairs Branch, but never clearly mentioned a sample comparison between veterans and non-veterans Intervention: Proactive-care smoking cessation intervention instruments used at baseline and re-evaluated 6-months and 1 year from initial survey. Questions address from the California Tobacco Survey and CDC Behavioral Risk Factor Surveillance Survey. (Burgess et al., 2014)
“The interacti

on between patient race and intervention condition (proactive care vs. usual care) was not significant.” (Burgess et al., 2014)
“African American quit at higher rates than whites. Finds might be in relation to a larger number of veterans receiving smoking cessation

Feasibility and Subjects availability limitation taken into consideration due to the length trail and data collection periods.

Internal validity due to multiple date collection point.
Smoking.Abstinence on survey was self-report, therefore to strengthen validity biochemical lab drawn is needed.

cessation rate.
-Simple Size n= 5123 randomized eligible participants. 2519 subjects was introduced to one intervention and 2604 subjects received usual care control group

12item attitude Nicotine Replacement Therapy scale measured.
Measured self-efficacy and motivation ability to quit smoking services and lack of racial difference in services.”(Burgess et al., 2014)
Due to the
VA educational smoking cessation programs that are offered to Veterans the study rate is higher 6.2% among smoking cessation in that particular population.
Chi-square and F test were used.

Synthesis of Literature

According to our research and findings regarding smoking and veterans, there is a significant association between proper nursing education and smoking cessation teaching integration to nursing care (Blow et al., 2012; Hamlett-Berry et al., 2014). The more educated, confident and given the proper tools, a nurse and interdisciplinary team can possibly make an impact while taking a step toward increasing cessation rates and improving outcomes for the special population of veterans (Battaglia et al., 2015). Those who are diagnosed with PTSD are more likely to smoke than individuals without mental illness (Battaglia et al., 2015). Nurses are on the frontline and have access to the patients, knowledge of their history, and opportunities for interventions to be implemented for inpatient smokers (Blow et al, 2012).
Significance Problem Purpose and Hypothesis Today in the United States of America, smoking is considered the leading preventable cause of mortality and is ultimately held accountable for 435,000 death per year (Battaglia et al., 2015). Among the general population, US veterans suffering and diagnosed with Posttraumatic Stress Disorder (PTSD), have statically shown to have higher smoking rates than those individuals without mental illnesses (Battaglia et al., 2015). One out of 10 smokers in the United States have been diagnosed with PTSD at some point in their lives and only half of those PTSD smokers have tried to quit smoking (Battaglia et al., 2015; Hamlett-Berry et al, 2014). This special population of veterans is more vulnerable and is more likely to smoke due to anxieties, PTSD, psychological and other emotional troubles due to deployments and military lifestyle (Burgess et al., 2014; Hamlett-Berry et al., 2014). Strategies are needed to reduce gaps in the inpatient cessation counseling such as engaging the nurses of inpatient smokers to educate and provide necessary tools, and this nurse-delivered information has been shown to increase success of smoking cessation (Battaglia et al., 2013). The focus of integrating smoking cessation programs for patients with PTSD into routine treatment is needed to reach this population due to high mortality, health care costs and morbidities seen associated with this diagnosis (Hamlett-Berry et al., 2014). Now over ten years after the events of September 11, 2001, little is known about incorporating the factors of smoking cessation, PTSD with a diagnosis post-9/11, and with the specific ages of 18-35. The brave veterans of today are battling a different kind of war than the veterans of past wars, and with change in the times generational changes are also inevitable. The purpose of our replication study is to highlight this younger generation of PTSD veterans and strengthen the existing studies so caregivers can provide an appropriate cessation approach for the veterans of today and protect the men and women from the repercussions of long-term smoking. The control groups of this study will receive the usual care of the PTSD Health Buddy program information, and care coordination (Battaglia et al., 2015). The independent variables are the integration of the stage-based motivational smoking cessation curriculum into the Health buddy, and weekly motivational interviewing and counseling by a nurse in addition to the usual PTSD and smoking cessation received by the control group( Battaglia et al., 2015). The dependent variables are the participant’s number of quit attempts reported, the results of care patient satisfaction, and mean score change for PTSD symptoms in the intervention group as compared to the control group (Battaglia et al., 2015). By focusing on this specific population sample and by integrating the usual PTSD Health Buddy care management program, with motivational interviewing and in addition to tele-health counseling calls, these interventions could possibly increase the readiness for change. Our hypothesis has three areas of focus for our age group of veterans 18-35 years old: by increasing readiness for change, veterans with PTSD with a post-9/11 diagnosis could possibly significantly increase in smoking cessation success rates. By healthcare workers using this approach, patient satisfaction is likely to increase we hypothesize change in behaviors will be a result of self-management skills and the increasing of motivation to progress along the stages of change (Battaglia et al., 2015).
Theoretical/Conceptual Framework The Transtheoretical Model (TTM) is a theoretical framework used to measure progression along the stages of change (Porchaske& DiClemente, 1984). This model is based on the concept of each individual being at different stages of readiness, and as readiness from interventions increases, the effect is a progression along the stage of change which in this case is to quit smoking (Battaglia et al., 2015). Based on change theory, behavior change is associated with self-management improvement, which represents a positive causal relationship between these two variables (Battaglia et al., 2015). A concept also used is from E.H. Wagner’s (1998) study, The Chronic Care Model is a framework that encourages the use of multi-modal and multi-disciplinary approaches for patient care and interventions, which improve patient outcomes seen within the dependent variables (Wagner et al., 1998). By incorporating this model as well into the study, it can improve self-management, which sets a foundation for a positive ripple effect of patient health status improvement, such as positive health choices and smoking cessation. The intervention of tele-health and motivational interviewing can help this study population feel less isolated and connected (Battaglia et al., 2015). These two models will ultimately provide guidance to the studies framework and support the design’s concept integrating the stages of change and improvement of self care management.
Study Design The replication study used is an experimental, randomized control trial to test the effectiveness of the integrative care of usual smoking cessation routines, in addition to tele-health and telephone motivational interviewing to veterans between the ages of 18 and 35 with a PTSD diagnosis post September 11, 2001. With the approval of the institutional review board, this study will use a convenience randomized sample to build on previous studies which strengthens our hypothesis and allows the collection of data necessary to represent outcomes specific to our veteran population used for our replication study. The level of evidence associated with our design was chosen in order to develop the strongest representation of the potential success of smoking cessation with interventions added within this study.
A pilot study was performed at the beginning of the research in order to test for population fidelity and feasibility (Battaglia et al., 2015). Data will be collected at baseline during enrollment and measured 3, 6, and 9 months post-intervention (Battaglia et al., 2015). Primary outcomes are self reported quit attempts measured on the daily, perception of care coordination, and PTSD symptoms while secondary outcomes will measure stages of change and 7 day quit rate (Battaglia et al., 2015). The control group will receive the standard information and usual PTSD Health Buddy program care coordination and usual care for smoking cessation (Battaglia et al., 2015). The intervention group will receive the usual care in addition to stage-based motivational interviewing on the Health Buddy, and weekly motivational interviewing with a nurse. This type of study design was used to effectively highlight the positive outcomes of the additional care received by the interventional group while maintaining dignity of the subjects, maintain ethical compliance and prove our hypothesis by comparing the control group data to experimental group post-intervention outcomes.
Sample Population The target population for this study are all PTSD veteran smokers between the ages of 18-35, those who wish to quit and those who do not. The study is promoted with fliers at multiple settings where bulletins and announcements are made at the Veteran’s Hospital, outpatient clinics as well as promoted in health provider’s offices and screening for criteria in Electronic Medical Records for ICD-9 codes appropriately (Battaglia et al., 2015). The recruitment period was over a five month timeframe to obtain a randomized group of participants (Battaglia et al., 2015). Subjects are recruited by invitations to participate that include information about the study, a baseline questionnaire and a refusal card (Battaglia et al., 2015). If the subject accepts the invitation a call from the research team will follow to determine eligibility, and those who refused will be removed from the potential subjects list database and if no reply after three attempts to contact via telephone (Battaglia et al., 2015). Inclusion criteria includes Veterans with a PTSD diagnosis documented in their medial record according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) as code 309.81 (Battaglia et al., 2015) after the events of September 11, 2001. The subject’s demographic variables include all genders, all ethnicities, a high school level education, must read and write in English, and married as well as single. Inclusion criteria also includes all participants are required to be the age of 18 years old, no older than 35 years old, willing to participate, able access a telephone line, and currently smoking one or more cigarettes per day (Battaglia et al., 2015). Exclusion criteria includes use of pipes, cigars or marijuana, smokeless tobacco, risk for violence or suicidal, severe psychiatric issues or irritability (primary care provider or mental health provider to assess ability to participate), cognitive issues, no telephone or inability to use and connect the telehealth device in their home (Battaglia et al., 2015). By the specific demographic and age requirement of this study our replication study will represent a newer generation of veterans. Calculations for size of study participants are based on the outcomes of the intervention as compared to the control group, in quit rate successful attempts and progress in stage of change, care coordination as perceived, and improvement of PTSD symptoms (Battaglia et al., 2015). Sample size is a target of 180 participants in order to account for an anticipation drop rate of 15-20%, with a goal of 120 participants to successfully complete the study (Battaglia et al., 2015). Alpha level of 5%, Type I error rate and a two sided t-tail test of means is used between the groups measured with effect sizes of 0.1, 0.25, and 0.4 used for the three areas measured for change and a 80% power (Battaglia et al., 2015). Statistical analysis will be used by statistical analysis software (Battaglia et al., 2015).
Conceptual Definitions of Variables

The conceptual definitions of the progression along the stages of change for smoking cessation, patients perception of care coordination and PTSD symptoms/health status are an elaboration of the framework and design of this replication study. After reviewing literature it is known that balanced decision making and self-efficacy are important factors that affect transitions along the stages of change (Battaglia et al., 2013). The perception of patient care coordination describes the patient’s feelings toward accessibility and interactions of counseling, engagement with necessary tools and overcoming barriers of treatment (Battaglia et al, 2015).
Operational Definitions of Variables

The independent variable of stages of change is measured by baseline survey data to mean change results data compared to post-interventional survey data at 3, 6, and 9 months post intervention (Battaglia et al., 2015). Assessment of the dependent variable of smoking cessation success which is considered a 7-days sustained of no smoking to verify cessation and quit attempts a CO2 level will be checked and a result of less than 10 will be verified during scheduled post intervention visits. The dependent variables of perception of care coordination will be represented by a mean score change of (PACIC) patient assessment of care for chronic conditions survey data of baseline intervention and post-intervention scores at 3, 6, and 9 months (Battaglia et al., 2015). PTSD symptoms will be represented by the use of a PTSD symptom survey data which includes three tools the (GDS) the geriatric depression screen, the McGill short form pain symptoms questionnaire, and health care related quality of life survey (VR-12) with measurements assessed by all baseline scores and comparing mean score changes to post-intervention data collected at 3, 6, and 9 months (Battaglia et al., 2015).
Data Collection Data collection was assessed at three specific points throughout the replication study. Data collection periods were measured at baseline, and once interventions were introduced data was collected at the three months, at 6 months, and at 9 months post-intervention periods (Battaglia et al., 2015). Self-survey questionnaires were addressed in the convenience of the participant’s home via The Health Buddy program, which was conducted by the assigned research team. A pilot study was introduced in order to test for fidelity and feasibility, supporting the intervention delivery method (Battaglia et al., 2015). Participants were also scheduled for an in-person follow-up survey and were compensated for each data collection survey for a total of $24. Baseline data collection included the following: expired carbon monoxide level, McGill Pain Questionnaire, PACIC, PTSD survey, Stage of Change, GDS, and VR-12 (Battaglia et al., 2015). Data collection during the 90-day intervention period was assessed both weekly and monthly, the intervention survey data was collected regarding participant’s satisfaction and MI counseling calls. A 24-hour cigarette recall was assessed weekly, in addition to monthly evaluations of potential suicide risk and progression along the stage of change (Battaglia et al., 2015). During the six-month follow-up period, data was collected and analyzed by a trained research team member on a monthly basis via telephone access. The last data collection set point was collected at nine months post-intervention and consisted of surveys to measure and compare mean score changes to baseline data (Battaglia et al., 2015). Trained research nurses are specially trained to effectively deliver study interventions of the smoking cessation curriculum and motivational intervention counseling among our studied population via telehealth. To assure for Interrater Reliability, research nurses will undergo multiple training sessions and refresher courses throughout the study to ensure consistency among the observed reported behavioral questionnaires seen in the data collection. The intervention outcome analysis was achieved by computing the chi-square test and the t-test when comparing the formulated hypothesis to baseline variables, against quit attempt outcome and change in readiness (Battaglia et al., 2015). These two tests provide significances in differentiating the interventions effectiveness among those veterans receiving the smoking cessation care management versus the controlled group. The statistical data received supports our hypothesis and suggests there will be a great possibility of an increase in readiness for change and a possible increase smoking cessation success rates seen in those veterans suffering from PTSD post 9/11. The Statistical analyses was conducted using the SAS (Cary,NC) (Battaglia et al., 2015). In order to gain accuracy and precision, the logistic regression model tested the hypothesis against other interpersonal baseline characteristics to make up for factors that could have possibly effect the interventions data (Battaglia et al., 2015). A multiple-linear regression model was also used as a measurement tool when comparing patient’s perception of care coordination and the change observed within the dependent variable of PTSD symptoms among the baseline (Battaglia et al., 2015). Intervention effectiveness was measured and utilized standardized tools that assessed pain level (Table B2), PTSD symptoms specific to the veteran population (Table B1), chronic care illness (Table B3), depression (Table B4), and quality of life (Table B5) (See Appendix B for more information). Based on the instruments used to test the intervention group, reliability and validity have been supported in multiple studies, providing accuracy and consistency among measured variables (LoBiondo-Wood and Haber, 2014). The PACIC and VR-12 health survey, are two unique measurement tools designed to measure psychosocial and behavioral variables using a Likert scale format. In order to test for internal consistency a Cronbach’s alpha coefficient needs to be greater than .80 to validate and have supporting evidence among these two instruments (LoBiondo-Wood and Haber, 2014). Kuder-Richardson (KR-20) coefficient was used to test the PTSD screening tool for reliability and homogeneity (LoBiondo-Wood and Haber, 2014). For this screening tool to be accepted as a true reflection of the variables the minimum accepted score is r = .70 (LoBiondo-Wood and Haber, 2014). Each instrument that was utilized within this study, links back to the general purpose and concept, overall providing confidence among findings. Participants within this study will be identified and coded based on a 7 digit numerical and alphabetical representation. The coding master sheet consists of participants 7 digit identification number assigned initially by the electronic health record system. This numerical ID will be converted into an alphanumerical ID. The master sheet will be keep confidential and stored on a secured USB drive in a locked room with badge only access (See Appendix C). Risks and Benefits This study is “minimal risk” because we are not taking away from normal care; we are adding more helpful tools for smoking cessation. There is a possibility these tools are not helpful for cessation in the particular group studied, possible smoking withdrawal, increased appetite, possible increase in PTSD symptoms and sharing of personal information and loss of privacy through survey questions during the study. Drawing blood for C02 level checks may cause some pain and has a small risk of bleeding, bruising, hematoma or infection at the puncture site. There is also a small risk of fainting during blood draw. You should not become pregnant or father a baby while on this study. If you are a woman who is able to bear a child, it is recommended to use a form of birth control while on this study. Refer to your physician for appropriate methods of birth control during this study. If you become pregnant during this study you must inform the co-researcher. Smoking puts your baby at risk for complications related to smoking. A pregnancy test will be given to any woman of childbearing years who wants to be in this study. A researcher will ask for the date when a woman’s last monthly period started. It is advised to continue all meds prescribed by your primary care physicians(s) during the course of this study, do not stop your routine medications because doing this may result in worsening of your chronic conditions. Routine visits and medical care by your primary care physicians should not be interrupted. There is a risk of unexpected findings during the course of this study such as psychological risks as assessed by the nurse during routine calls and if a medical emergency arises, the nurse will notify the study doctor or call 911 if needed and/or if you are a threat to yourself or others. Your condition may not improve or may worsen while you are taking part in this research study. In addition to the risks of the research procedures, if you take part in this study, there are risks associated with the standard procedures used in this study, which have been previously listed. These are risks that you would be exposed to as part of standard care for your condition, even if you did not take part in the study. The full benefits of participating in this study are currently unknown. It is possible integrating the intervention tools used in this study, with usual smoking cessation care, will increase the likelihood of smoking cessation success rates. It is unknown whether the interventions are more beneficial for the group studied than usual care alone. If you agree to take part in this research study, there may or may not be a direct medical benefit to you. It is possible that in the future the information learned from this study will benefit other people with your PTSD and smoking conditions. There is no guarantee you will benefit from this study. It is possible that your smoking condition may not change or have the possibility of getting worse. Privacy protection and Confidentiality of Data Information about you that is collected for this research study will remain confidential unless given permission to share, or if we are authorized or required by law to release it. Written consent is required for participation of this study (see appendix A). Privacy will be upheld but there are certain organizations that could possibly review the study records and medical records for research, quality assurance, and data analysis such as institutional review boards (LoBiondo-Wood and Haber, 2014). If information is used for teaching or publications, your identity will remain confidential. Information regarding subjects is in a locked room with a computer that requires a badge for access and password for entry into the computer. Only the doctor and co-researchers are able to view patient information. You will be given a unique code as opposed to a name for data collection, which will maintain your confidentiality. We will take additional steps to try to protect your privacy, such as storing your private information in a secure location where only authorized individuals will have access to it. In research personal information is kept minimal to uphold and maintain patient confidentiality. All members in the study are trained on how to collect, handle and maintain confidential data and secure storage and management of identifiable information. You will be asked to sign a separate “Authorization to Use or Disclosure Protected Health Information for Research”. This form will outline with whom your information may be shared for the purposes of this research, which clearly states what information is shared, and the right to not give permission is also your right. If you do not give us the permission to use this information for this research study, you will not be able to take part in the study. The research study records may include information that could identify you such as your name, birthday or medical record number. If information can be identifiable to you it is considered private and you are protected against this. Only the doctor and co-researchers are able to view patient information and identifiable information. You will be given a unique code to be referred to as opposed to a name for data collection and analyzing of information. We will take additional steps to try to protect your privacy, such as storing your private information in a secure location where only authorized individuals will have access to it and information used for this study to link your data and your personal information is kept confidential. All study personnel in the study will be trained in maintaining secure data and fulfilling obligations to the subjects for privacy, confidentiality of personal, identifiable information.

References

Battaglia, C., Buchanan, L., Fu, S., Grant, K., Hills, S.L., Holman, J., Johnson, S., Katz, D.A., Ono, S., Paez, M., Prochazka, A., Stewart, K., Titler, M., Weg, M.W. (2013). Implementing smoking cessation guidelines for hospitalized veterans: Effects on nurse attitudes and performance. Journal of General Internal Medicine, 28 (11), 1420-1429. Doi:10.1007/s11606-013-2464-7
Battaglia, C., Peterson, J., Prochazka. (2015). Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for randomized control trial. BMC Health Services Research, 15 (46), 1-10. Doi: 10.1186/s12913-015-0706-6
Burgess, D.J., Clothier, B., Fu, S.S., Joseph, A.M., Noorbaloochi, S., Taylor, B.C., Van Ryn, M. (2014). Smoking cessation among African American and White smokers in the Veterans affairs Health Care System. American Journal of Public Health, 104(S4), S580-S587. Doi:10.2105/AJPH.2014.302023
Blow, F.C., Duffy, S.A., Ewing, L.A., Jordan, N., Landstrom, G.L., Ronis, D.L., Thomas, P.L., Titler, M.G., Waltje, A.H. (2012). Dissemination of the nurse-administered Tobacco Tactics intervention versus usual care in six Trinity community hospitals: study protocol for a comparative effectiveness trial. Trials Journal, (13)125. Retrieved from http://www.trialsjournal.com/content/13/1/125
Greenberg, S. (2012).The Geriatric Depression Scale. Hartford Institute for Geriatric Nursing. Retrieved from: http://consultgerirn.org/uploads/File/trythis/try_this_4.pdf.
Group Health’s MacColl Center for Health Care Innovation. (2004). Assessment of care for chronic conditions. Retrieved from: http://www.improvingchroniccare.org.html
Hamlett-Berry, K., Beckham, J., Ebert, L., Malte, C., McFail, M., Saxon, A. (2014). Use of Learning Collaborative to support implementation of Integrated care for smoking cessation for Veterans with post-traumatic stress disorder. American Journal of Public Health, 104(10), 1935-1942.
Libondo-Wood, G., & Haber, J., (2014) Nursing research: Methods and critical appraisal for evidence based practice (8th ed.). New York: Mosby Elsevier. ISBN:979-0-323-10086-1
Melzack, R., (1975). The McGill pain questionnaire: Major properties and scoring methods. 1, 277-299.
Prins, A., Ouimette, P., Kimerling, R., Cameron, R. P., Hugelshofer, D. S., Shaw-Hegwer, J.Thrailkill, A., Gusman, F.D., Sheikh, J. I. (2003). The primary care PTSD screen (PC-PTSD): Corrigendum. Primary Care Psychiatry, 9, 15.
Stein, C., & Mendl, G., (1988). The German counterpart to McGill pain questionnaire. 32(1), 251-255.
The United Stated Department of Veterans Affairs. (2010). The Veterans RAND 12-item health survey [Date file]. Retrieved from http://www.rand.org/health/surveys_tools/mos/mos_core_12item.html
Wagner, E.H., Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998;1:2-4.

Appendix A

ADULT CONSENT FORM TO BE IN RESEARCH

POST-9/11 VETERANS WITH PTSD: A BATTLE WITH SMOKING

|SECTION |PAGE |

A. Who is conducting this research study? 15

B. What is the purpose of this research study? 15

C. Why are you invited to take part in this study? 15

D. How many people will take part in the study? 15

E. What will you be asked to do? 16

F. Can you stop being in this study? 19

G. What are the possible risks, side effects, or discomforts of being in this study? 19-20

H. What are the benefits of taking part in this research study? 21

I. What options are there to being in this study 21

J. Are there potential conflicts of interest? 21

K. What about your privacy? What about confidentiality of your private health information? 22-23

L. What are the costs of your being in this research study? 18

M. Will you be paid for being in this study? 18-19

N. What if you have an illness or injury related to being in this study? 24

O. What are your rights as a human research subject? 25

P. Whom do you call if you have questions or problems? 25

Q. Consenting to be in this study: 26-30

|You are being asked to take part in a research study. This form describes the study. Please read it carefully and discuss it with the doctor|
|and co-researcher before you agree to take part by signing the form. |

ADULT CONSENT FORM TO BE IN RESEARCH

POST-9/11 VETERANS WITH PTSD: A BATTLE WITH SMOKING

A. Who is conducting this research study?

Main Study Doctor/Main Researcher: John Smith, MD 832-222-5500

Co-Researcher: Morgan Matthews, RN-BSN 832-222-5100

Primary Study Coordinator: Brenda Pizana, RN-BSN, CPAN 832-222-3200

Study Site(s): __Veterans Health Associated hospital and community based clinics, Dr John Smith’s office as headquarters_________________________

This research study is sponsored by the Department for Veterans with PTSD.

B. What is the purpose of this research study?

The purpose of this study is to gain more knowledge about how integrating other smoking cessation tools impacts success rates. There has been research to highlight how common smoking is with PTSD but little is known about the specific age groups of ages 18-35 and a PTSD diagnosis after 9/11. The purpose of this study is to highlight these younger generations and integrate smoking cessations tools to their routine medical treatment.

This study is considered research because we will be comparing how adding extra smoking cessation interventions affect smoking cessation and compare results to regular routine cessation teaching outcomes.

C. Why are you invited to take part in this study?

Option 1. Study subjects: You are being asked to take part in this study because you are a smoking veteran with a PTSD diagnosis after 9/11 and you are between the ages of 18 and 35.

Research studies include only people who choose to take part. Please take your time to make your decision and discuss it with your friends, family and/or doctor. Remember that your decision to be in this study is your choice.

D. How many people will take part in the study?

About 120 people will take part in this study at this study site and surrounding VA clinics.

E. What will you be asked to do?

Summary

This is a “Randomized” study, which means that you will be assigned to a study group by chance, like flipping a coin. You will be randomized into one of 2 study groups, and will have a 50/50 chance of being placed in either of the 2 groups. You must be cleared by your primary care physician and will continue routine medical treatment and follow-ups.

If placed in the group not receiving the study’s trial you will receive “standard care” which includes care management using the PTSD health buddy and routine care for tobacco cessation. Assessments will be done at baseline, 3, 6, and 9 months after receiving routine smoking cessation tools.

If placed in the group receiving the study’s intervention, you will receive Care management using the PTSD health buddy and usual care smoking cessation in addition to stage-based motivational interviewing (MI) tobacco cessation curriculum on the Health Buddy, and weekly MI counseling calls with a nurse.
You will be in the study for about 10 months. You will continue routine care and data will be collected at baseline prior to the study at enrollment and the last data is collected at 9 months post-intervention.

Procedures

The procedures in this research study may be standard or research-related; “Standard of Care Procedures” would be done even if you did not take part in this study. “Research-Related Procedures” are done only for research purposes and are either standard of care procedures or other routine procedures (like an x-ray or blood test). “Investigational Procedures” are procedures, drugs, or devices that are being tested in the study. Research-Related and Investigational Procedures would not be performed if you did not take part in this study. For a clear breakdown, please refer to the study procedures table.

The following research procedures will be conducted during this study: • 90 Health Buddy sessions with useful information and self-monitoring questions about PTSD via the Health Buddy • Daily monitoring of your responses by the nurse with phone calls as needed tailored to your urgent needs or clinical status change • Referral to usual care regarding smoking cessation meds, if requested • Motivational stage-based cessation material which include information on addiction, goals, change, long-term cessation, and alternatives, health risks and costs • Weekly called from the nurse care coordinator with a target number of 12 calls, this nurse gives advice, helps with your goals, helps with difficult barriers, provides a non-judgmental environment for you to voice your concerns • You will provide baseline data on enrollment as well as surveys given via the Health Buddy and surveys on follow up visits

You will be asked to complete a survey. You will be asked questions to evaluate your smoking cessation success. It should take about 20 minutes to complete the survey. You will be asked to complete the survey at the 3, 6, and 9 month follow up visits and will be compensated a total of $24 for all surveys. If you are not comfortable answering any question, you are not required to answer it. The survey will contain information that can be used to identify you, such as your code number than can be linked to your name.

Section K tells you who will be allowed to receive and use any of this information, if you give your permission by signing this consent form.

Table 1: Procedures

|Procedure |Baseline |3 mos |6 mos |9 mos | |
|Standard of Care Procedures: Procedures that are part of |x |x |x |x | |
|regular care and would be done even if you did not take | | | | | |
|part in this research study | | | | | |
|PTSD health buddy |X |X |X |X | |
|Standard smoking cessation care | | | | | |
| |x |x |x |x | |
|Research Related Procedures: Procedures that are done only| | | | | |
|for research purposes and are either standard of care | | | | | |
|procedures or other routine procedures (like an x-ray) | | | | | |
|CO2 level check for quit attempts | |x |x | | |
|Investigational Procedures: Procedures, drugs, or devices | | | | | |
|that are being tested in this research study | | | | | |
|Care coordination with PTSD Health Buddy |X |x |X |x | |
|Smoking cessation integrated with healthy buddy program | | | | | |
|MI weekly calls by nurse | | | | | |

F. Can you stop being in this study?

Taking part in this study is up to you. You may refuse to be in the study or you may stop being in this study at any time. If you decide not to participate, or you withdraw, you will not have any penalty or loss of benefits to which you are entitled and this will not affect your future medical care.

There will not be any consequences of withdrawal from this study. Subjects who do not respond will be classified as continuing smokers.

The main study doctor and or co-researchers may decide to take you off this research study, even if you would like to continue. Some examples of why you might be taken off the study are:

• If the doctor or co-researcher determines that it is in your best medical interest; • If your condition worsens; • If you do not follow the instructions given to you by the doctor or co-researcher • If it is discovered that you do not meet the study requirements, at the doctor or co-researcher’s discretion; • If funding for the study is stopped or the study is canceled; • If the whole study is stopped or modified for any reason; • If the study drug or device is approved for commercial use; or • For administrative reasons, such as the target number of subjects has already entered the study.

Will the researchers tell you about new information that may affect your decision to continue in this study?

The researchers will tell you if they learn important new information that may affect your health, welfare, or your willingness to stay in this study. If new information is given to you after you have joined the study, it is possible that you may be asked to sign a new consent form that includes the new information.

G. What are the possible risks, side effects, or discomforts of being in this study?

This study is “minimal risk” because we are not taking away from normal care, we are adding more helpful tools for smoking cessation. There is a possibility the tools are not helpful for cessation, possible smoking withdrawal, increased appetite, possible increase in PTSD symptoms and sharing of personal information and loss of privacy through survey questions during the study.

Sample Risk Table
Risks of Study Drug A
|Very Likely |Less Likely |Rare, but Serious |
|Smoking withdrawal | | |
|Failure to cease smoking |PTSD increase of symptoms | |
|Multiple quit attempts |Change in health status |none |
|etc. | | |

Blood Draw for CO2 level monitoring Drawing blood may cause some pain and has a small risk of bleeding, bruising, or infection at the puncture site. There is also a small risk of fainting.

You should not become pregnant or father a baby while on this study. If you are a woman who is able to bear a child, you must use birth control while on this study. If you are a man who is able to father a child, you must use a medically accepted method of birth control while on this study. Acceptable methods of birth control during this study any prescribed by your primary care physician. If you become pregnant during this study you must inform the co-researcher. You should not nurse your baby while you are in this study nor is it advised to smoke at all during you. Smoking puts your baby at risk for low birth-weight and risk for miscarriage.

Pregnancy test: A pregnancy test will be given to any woman who is able to have children and wants to be in this study. A pregnancy test may be given. A researcher will ask for the date when a woman’s last monthly period started.

It is advised to continue all meds prescribed by your primary care physicians(s) during the course of this study, do not stop your routine medications doing this may result in a worsening of your condition.

If the study procedures/tests may possibly result in incidental findings, please insert the following:

The blood sample could make you and doctor and co-researchers aware of a disease that would otherwise not have been detected at this time. This may result in more testing being recommended. You will be advised of these findings. You will be encouraged to speak to your doctor about them.

Your condition may not improve or may worsen while you are taking part in this research study.

In addition to the risks of the research procedures, if you take part in this study, there are risks associated with the standard procedures used in this study. These are risks that you would be exposed to as part of standard care for your condition, even if you did not take part in the study. (Please see Section E for the listing of standard procedures in this study.) Your co-researcher will discuss the risks of standard care with you.

What is a Data Safety Monitoring Board? A Data Safety Monitoring Board (DSMB) is an independent group of experts that will be reviewing the data from this research throughout the study. The DSMB periodically reviews the progress of the study including data collected in order to see that the study is safe for the subjects taking part in the study.

H. What are the benefits of taking part in this research study?

The benefits of this study are currently unknown. It is possible integrating these interventions with usual smoking cessation care will increase the likelihood of smoking cessation success. It is unknown whether the interventions are more beneficial for the group studied than usual care alone.

If you agree to take part in this research study, there may or may not be direct medical benefit to you.

It is possible that in the future the information learned from this study will benefit other people with your condition.

No one can guarantee you will benefit from this study. It is possible that your condition may remain unchanged or even get worse.

I. What options are there to being in this study

You do not have to take part in this research study.

J. Are there potential conflicts of interest?

A “conflict of interest” is a circumstance in which different interests could influence a person’s decisions. The doctor and co-researchers must follow federal rules for identifying and managing possible conflicts of interest before a research study can be approved. This is to make sure that the design, conduct (actions taken) and reporting of the research will not be influenced by any conflicting interests.

The main doctor, Dr. John Smith and co-researchers, do not have any financial interest in the study results. This means that the doctor and researchers will not make or lose money due to the results of the study (positive or negative).

The main doctor, Dr. John Smith and co-researchers do not have any financial interest in this study. This means that he/she will not make or lose money due to the results of the study (positive or negative). However, the [add as appropriate, “the hospital, Texas Health Research & Education Institute, the study coordinators”] will be paid by the sponsor for the work that they and their staff do as part of this study, and for the use of THR hospitals and facilities.

The VA hospital and associated outpatient clinics do not have a financial interest in the study results.

Money is not the only thing that can cause a conflict of interest. For example, being invited to take part in research by your doctor could be a conflict of interest. In such case, your doctor has an interest in both your care and in the success of this research study. For purposes of the research, the decisions the main doctor, Dr.John Smith makes for your care will be directed by the study plan for the research study. For purposes of your medical treatment, the decisions your doctor makes for your care are based on your doctor’s judgment and your wishes.

You should realize, however, that in either case, your doctor is committed to providing quality care, even if that may mean that you cannot take part in the research. You can choose not to take part in the research or stop taking part in the research study and still receive treatment from your doctor. If you wish, you may also speak about your options with another doctor, who also specializes in treating your disease or condition but who is not a member of the research team.

K. What about your privacy? What about confidentiality of your private health information?

General Comments

This section discusses how your private information will be kept confidential. It will also discuss the limited ways it may not be kept confidential.

In research, information collected about you will be compared to information collected about other research study participants. Most research study records have some sort of information that may identify you.

You will be asked to sign a separate “Authorization to Use or Disclosure Protected Health Information for Research”. This form will outline with whom your information may be shared for the purposes of this research. It will also state under what circumstances it may be shared. You can choose not to give your permission for us to use this information. This choice is a very important right that you have. If you do not give us the permission to use this information for this research study, you will not be able to take part in the study. See Section O for more information about your rights as a research subject.

If you have any questions after reading the following sections, please contact the doctor or co-researchers at the number listed in Section A.

What private information will be collected?

The research study records may include information that could be used by another person to identify you. General examples would be information that shows your name or your medical record number. When the information can identify you, we call it “private information”. If the information can identify you, it may be used and shared as the law allows and will not affect your privacy.

Confidentiality of private information

Information about you that is collected for this research study will remain confidential unless you give your permission to share it with others, or if we are authorized or required by law to release it. You should know that certain organizations may look at and/or copy your research-related records and medical records for research, quality assurance, and data analysis include:

• The VA institutional review board, and Medical review board • Representatives of government agencies, like the Office for Human Research Protections (OHRP), involved in keeping research safe for people • The Texas Health Institutional Review Board.

How will your private information be protected?

If information used for teaching or publications your identity will remain confidential.

Information regarding subjects is in a locked room with a computer that requires badge and password for entry. Only the doctor and co-researchers are able to view patient information. You will be given a unique code as opposed to a name for data collection.

You will be mailed a total of $24 upon completion of all 3 follow up surveys.

We will take additional steps to try to protect your privacy, such as storing your private information in a secure location where only authorized individuals will have access to it.

How will information about you be used in teaching and publication?

If information about the research study is used for teaching or in publications, private information will not be made public and your identity will be kept confidential.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Protections from Forced Disclosures (Subpoenas) – Certificates of Confidentiality

To further protect your personally identifiable information, we (study personnel listed in Section A) intend to apply for a Certificate of Confidentiality from the federal government. Under subpoena, the sponsor, Dr. John Smith and co-researchers, or Texas Health Resources and the study site may be asked to reveal data that would include your private information. A Certificate of Confidentiality is intended to prevent the forced sharing of your research records under any circumstances, including a subpoena.

While the Certificate of Confidentiality protects against forced sharing, Texas Health Resources institutional policy requires that Dr. Smith and research staff follow certain reporting requirements of the State of Texas even if there is a federal Certificate of Confidentiality. This means that Dr. John Smith and research staff must act on and possibly share information about the possible abuse of or harm to a child, dependent adult, elder, yourself or another person, even if a Certificate of Confidentiality is in place. If the doctor and research staff receive this type of information, the doctor and research staff will need to take measures to protect the appropriate individuals from further abuse or harm.

L. What are the costs of your being in this research study?

You and your insurance company will not be charged for your participation in this research study.

You or your insurance company will not be charged for research-related procedures. The costs of procedures listed in Section E that are considered standard care will be charged to you or your insurance company. If the insurance company does not pay for all of the procedures, you will have to pay for those charges. Telephone access for the Health Buddy and transportation to and from office visits expenses are the participants responsibility.

M. Will you be paid for being in this study?

You will be paid $8 per follow up visit at 3, 6, and 9 months post intervention. The total amount you will receive if you complete the whole study is $24. If you do not complete the entire study, you will only be paid for those visits and procedures you do complete.

Because payments made to you for participating in this study may be reported to the Internal Revenue Service (IRS) as income, you are required to provide your social security number and sign a W-9 form. Your participation in this study does not make you an employee or agent of the study, sponsor, investigator(s), IRB or any of the companies involved in this study.

N. What if you have an illness or injury related to being in this study?

Your health insurance company may not cover you for an injury that is due to being in this study and is not due to your condition. Neither your researcher, Texas Health Resources, or VA hospital system nor associated clinics agree to give free medical or hospital care or payment for any injury from being in the study. By signing this consent, you do not give up any legal rights that you already have.

O. What are your rights as a human research subject?

• You have the right to refuse to take part in a research study without any penalty or loss of benefits to which you are otherwise entitled. Taking part in this research is your choice. • You have the right to drop out of this study at any time without any penalty or loss of benefits to which you are otherwise entitled. • You have the right to be given important new information that may affect your health, welfare, or willingness to stay in this research. • You have the right to ask questions at any time and have them answered as soon as possible.

Whether or not you take part in this research study or decide to leave the study, it will not affect the care you receive by your doctors or the VA hospital system and associated clinics.

P. Whom do you call if you have questions or problems?

If you have questions or concerns about this study, please contact the Dr. John Smith or one of the co-researchers Brenda Pizana or Morgan Matthews, listed in Section A of this consent form. After hours and on weekends, call Dr M. Pizana 832-222-5300. If you have a sudden, serious problem, like difficulty breathing or severe pain, go to the nearest hospital emergency room, or call 911 (or the correct emergency telephone number in your area). Tell emergency personnel about any medications you are taking, including any medications you are taking for this study.

If you have questions, concerns, or comments about your rights as a research subject or regarding research-related injuries, please contact the party listed below: Institutional Review Board (IRB) Texas Health Resources Phone: (682) 236-6746 Email: irb@texashealth.org

The IRB includes doctors, scientists, non-scientists, and community members. The IRB reviews, approves, and monitors all human research at Texas Health Resources. The IRB role is to review research studies in order to protect the rights and welfare of subjects taking part in research.

Q. Consenting to be in this study:

You are deciding if you want to be in this study. You should not sign until you understand all the information in this form and until all of your questions about this study have been answered. Signing this form shows that you have decided to be in this study, having read (or been read) the information given above.

1. You understand this is a research study. [ ] Yes [ ] No 2. You understand risks of being in this study. [ ] Yes [ ] No 3. You understand how long you will be in this study. [ ] Yes [ ] No 4. You understand the purpose and hopes for outcomes of this study. [ ] Yes [ ] No 5. You understand you can stop being in this study at any time. [ ] Yes [ ] No 6. You understand that confidential information about you from this study may be shared or disclosed. [ ] Yes [ ] No 7. You understand that you have a choice whether or not to be in this study. [ ] Yes [ ] No 8. You understand that your participation in this study does not make you an employee or agent of the study, sponsor, investigator(s), IRB or any of the companies involved in this study. [ ] Yes [ ] No

If you did not answer “yes” to all of the above questions, please review being in this study again with the researcher. You should only sign this form on the signature page at the end of this form when you have answered “yes” to all of the questions above.

Future Contact: If there is other related research in the future may those persons listed on section A of this informed consent form contact you about the possibility of being in that study? [ ] Yes [ ] No

You will be given a copy of this signed and dated consent form.

SIGNATURE BY THE SUBJECT OR
THE SUBJECT’S LEGAL REPRESENTATIVE:

Name of Subject (Print) Signature of Subject Date of Signature

SIGNATURE BY THE RESEARCH COORDINATOR

I attest that all the elements of informed consent described in this form have been discussed fully in non-technical terms with the subject or the subject’s legally authorized representative. I further attest that all questions concerning non-clinical issues, asked by the subject or the subject’s legal representative, were answered to the best of my knowledge. Additionally, I attest that neither the subject, nor the subject's legal representative, had any questions about clinical issues or medical treatment that were not answered by the main and/or co-study doctor.

Signature of the Research Coordinator Date of Signature

For Purposes of Pre-screening to Determine Eligibility (procedures to be completed were

not investigational or done solely for research purposes)

Statement of Dr. John Smith obtaining consent:

I have fully explained this study to the subject. I have discussed the study’s purpose, its experimental and non-experimental procedures and interventions, the possible risks and benefits, the standard and research aspects of the study, the alternatives to participation, the voluntary nature of the participation, and the source of funding for the research and conflict of interest on the part of the research staff. I have also discussed the information required under the HIPAA Privacy Rule in a separate document entitled Authorization to Use or Disclose Protected Health Information for Research. I have invited the subject to ask questions and have answered any questions that the subject has asked.

_____________________________________________ __________________ Signature of the Date of Signature Main study doctor ____________________________________ Printed name

SIGNATURE BY THE WITNESS/INTERPRETER

I attest that the information in the consent form, any other written information as well as questions and answers to and from the subject or the subject’s legally authorized representative were conveyed in the consent process. I also attest to the validity of the subject’s or legally authorized representative’s signature and that the informed consent was freely given by the subject or the subject’s legally authorized representative.

Signature of Witness Date of Signature

____________________________________ Printed name

I attest that I accurately conveyed all information as well as questions and answers to and from the subject or the subject’s legally authorized representative.

Signature of Interpreter Date of Signature

____________________________________ Printed name

____________________________________ Interpreter Employed By:

AUTHORIZATION TO USE OR DISCLOSE
PROTECTED HEALTH INFORMATION FOR RESEARCH

SIGNING THIS FORM GIVES AUTHORIZATION (PERMISSION) FOR THE RESEARCHER, HEALTH CARE FACILITY AND IRB TO USE AND DISCLOSE (SHARE) YOUR PROTECTED (PRIVATE) HEALTH INFORMATION FOR THE RESEARCH NAMED HERE:

Title of Research Project: Post-9/11 Veterans with PTSD: A battle with smoking
Leader of Research Team: Brenda Pizana, RN, BSN, CPAN
Address: 123 First Street, Houston, TX 77001
Phone Number: 832-222-3200

What information will be used or shared? If you give authorization, the health care facility where you received treatment or testing will make available (disclose) to the researcher your protected health information as necessary for this study as described below. I understand that specified information to be released may include, but is not limited to: history, diagnoses, and/or treatment of drug or alcohol abuse, mental illness, or communicable disease, including Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS).

1. Co2 lab draws
2. survey results
3. quit rate results

Why will the information be used or shared? If you give authorization, the researchers may use or disclose your protected health information for the following specific purposes:

1. to gain knowledge of PTSD for the age group of 18-35years old
2. to support integrative care for smoking cessation
3. to build on previous studies and promote health in our veteran community

The researchers may also use or share your private information to develop new procedures or commercial products.

Who will get my information? If you give authorization, the researchers may disclose your protected health information to the research sponsor, inspectors who check the research, the Institutional Review Board (IRB) overseeing the research, and government agencies like the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). The researchers may also disclose your information to the following people:

1. The research team, names provided on page 2 of this consent
2. Director of Research Compliance Texas Health Resources, 612 E. Lamar Blvd., Ste. 1212, Arlington Texas 776011 If you have questions call 682-236-6746

Confidentiality. The researchers may report their findings in scientific reports, but they will not name you in their reports. The researchers will try to keep your information confidential, but this cannot be guaranteed. The government does not require everyone who might see or receive your information to keep it confidential, so it might not remain private.

Voluntary Choice. The choice to give authorization to use or disclose your protected health information is voluntary. It is completely up to you. No one can force you to give authorization. Refusing to give your authorization will not affect your ability to get normal treatment, payment, or health benefits from your physician or health care provider. However, you must give authorization for the researchers to use or disclose your protected health information if you want to participate in the research.

Canceling Permission. If you give the THR researchers authorization to use or disclose your protected health information, you have a right to cancel your authorization whenever you want. However, canceling your authorization will not apply to information that the researchers have already used or disclosed.

To cancel your authorization (permission), you must write to either of the following:

1. The Leader of the Research Team named at the beginning of this form or

2. Director Research Compliance Texas Health Resources, 612 E. Lamar Blvd., Ste. 1212, Arlington Texas 76011 If you have questions call: 682-236-6746

End of Permission. Unless you cancel it, authorization to use or disclose your protected health information for the research will end when 9 month post intervention data is collected

Giving Permission. By signing this form, you are giving Texas Health Resources (THR), and the research team named on this form, authorization (permission) to use or disclose (share) your protected (private) health information for the research named on this form.

Patient/Subject Name: ______________________ Date of Birth

_____________________________________________________
Signature of Patient-Subject or Legal Representative** Date

** If signed by a Legal Representative, a description of the relationship to the Patient-Subject and the Authority to Act as Legal Representative must be attached to this form.

A signed copy of this form must be given to the Patient-Subject or the Legal Representative.

Appendix B

Primary Care PTSD Screen (PC-PTSD)

Description
The PC-PTSD is a 4-item screen that was designed for use in primary care and other medical settings and is currently used to screen for PTSD in veterans. The screen includes an introductory sentence to cue respondents to traumatic events. The authors suggest that in most circumstances the results of the PC-PTSD should be considered "positive" if a patient answers "yes" to any 3 items. Those screening positive should then be assessed with a structured interview for PTSD. The screen does not include a list of potentially traumatic events.
Scale

Instructions:
In your life, have you ever had any experience that was so frightening, horrible, or upsetting that, in the past month, you:

1. Have had nightmares about it or thought about it when you did not want to? YES / NO

2.Tried hard not to think about it or went out of your way to avoid situations that reminded you of it? YES / NO

3.Were constantly on guard, watchful, or easily startled? YES / NO

4. Felt numb or detached from others, activities, or your surroundings? YES /NO

Current research suggests that the results of the PC-PTSD should be considered "positive" if a patient answers "yes" to any three items.

(Prins et al., 2003)
[pic]

(Melzack, 1975)
[pic]

(Melzack, 1975)
[pic]
(Melzack, 1975)
[pic](Melzack, 1975)
[pic]

(Melzack, 1975)
[pic]
(Melzack, 1975)
[pic]
(ACCC,2004)

[pic]

[pic]

(ACCC,2004)
[pic]

(Greenberg, 2012)

[pic]

(NCQA, 2011)

[pic]

(NCQA, 2011)

[pic]

(NCQA, 2011)
[pic]

(NCQA, 2011)

Appendix C

Measures used to protect patient confidentiality. A 7 digit numerical identification number was initially assigned by using the electronic health record system ID number for each patient. The numerical identification is then converted into an alpha-numerical ID. This ID will be assigned in order to keep data collection confidential.

1. 7 Digit Numerical ID – From the electronic health record system 2. To create the code 10 randomized letters from the alphabet are assigned to the following numbers: (For clinical and trial purpose only)

0 |1 |2 |3 |4 |5 |6 |7 |8 |9 | |A |H |R |U |B |Z |M |P |L |J | | 3. Data collection ID is then generated by using the first four and the last numerical digits from the electronic health record and used to convert to the corresponding alphabets.

Example: Patient #1 – Electronic Health Record Number: 5901214 Data Collection ID: ZJAH21B

-----------------------
Table 1: Post Traumatic Stress Disorder Screen

Table 2: McGill Pain Questionnaire

Table 3: Patient Assessment of Care for Chronic Conditions (PACIC, 20 items)

Table 4: Geriatric Depression Scale

Table 5: VR-12 20 Item Short Form Health Form Health Survey