Veteran Peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH)

The purpose of this study is to test if having a Veteran peer health coach will improve blood pressure control among Veterans with high blood pressure and at least one other Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity, and smoking cessation. Facilitators, barriers, and costs of the intervention will be determined.

The Vet-COACH study is a peer health coaching program to help reduce Cardiovascular disease (CVD) risk among Veterans. The goal of the study is to test the effectiveness of a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple CVD risk factors with a hybrid type 1 implementation study. The study will focus on Veterans with poorly controlled hypertension and at least one other CVD risk factor to target a high risk population. The study will conduct a randomized controlled trial to enroll n=400 Veterans to compare a peer health coach intervention consisting of home visits, telephone support, and linkages to appropriate community-based and clinic resources compared to usual VHA primary care. The primary outcome is reduction in systolic blood pressure from baseline to follow-up at 1-year. Secondary outcomes include a reduction in Framingham Cardiovascular risk score, individual cardiovascular risks (tobacco use, lipids), health related quality of life, and health care use. The investigators will also assess the effects of the peer health coach intervention on intermediate outcomes including social support, patient activation, patient/provider communication and health behaviors (e.g. medication adherence, physical activity, nutrition, alcohol use, and stress management). The cost of the intervention will be assessed to inform feasibility for future studies, determine Veteran and staff satisfaction with the intervention, and identify barriers and facilitators to adoption.

Smoking (tobacco use), Peer health coach, Systolic blood pressure, Framingham Cardiovascular risk score, Lipid, Health related quality of life, Health care utilization, Medication adherence, Physical activity, Nutrition, Alcohol use, Stress management

Parallel: Participants are assigned to one of two groups--the control or intervention group- in parallel for the duration of the study.

Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors.

Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.

The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).

Reduction in Framingham Cardiovascular risk score (FRS), which has good predictive validity for Coronary Heart Disease events. FRS algorithms include age, total and high-density lipoprotein cholesterol, systolic blood pressure, treatment for hypertension, diabetes, and cigarette smoking.

Tobacco use will be measured as an individual cardiovascular risk. Tobacco use will be calculated based on self-reported number of cigarettes smoked, and/or of use of chewing tobacco, snuff, or snus. Questions on tobacco use will be taken from the Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire.

Overall Health will be assessed using the 12-Item Short-Form Health Survey to measure health related quality of life, which includes a summary assessment of role limitations caused by physical health, physical functioning, mental health, and general health.

Health care utilization will be measured using VA administrative data, including number of outpatient and ER visits, hospitalizations during the previous year.

Body Mass Index (BMI) will be measured as an individual cardiovascular risk. Measurements will be initially recorded in height (feet/inches), and weight (pounds/ ounces, which will be converted to weight in kilograms and height in meters. BMI will be calculated as kg/m^2.

Low density lipoprotein cholesterol (LDL-c) will be measured as mg/dL. Lipoprotein cholesterol will be assessed as an individual cardiovascular risk, and will be based laboratory data of blood tests from VA CPRS medical records (when taken within 6 months of baseline and/or 1 year follow up appointment). If no lab data exits within this timeframe, blood will be drawn by the study nurse.

Health care utilization will be measured using the High Risk Patient Survey to collect self-reported use of non-VA care services, including outpatient and ER visits, hospitalizations, or pharmacy utilization.

The 8-item Medical Outcomes Study (MOS) Social Support Survey Instrument will be used to measure self-perceived overall social support, including community support.

The CHAI will be used to measure patient activation, including self-rated ability to take preventive actions, manage symptoms of medical problems, find and use appropriate medical care, and work with health care providers.

Consumer Assessment of Health Plans (CAHPS) Clinician & Group Survey and Reporting Kit (Four-Point Scale)

The CAHPS survey will be used to measure patient satisfaction and patient/provider communication with the participant's physician and health care team.

The IPAQ will be used to measure exercise and physical activity, which will assess self-management health behaviors.

Self-reported medication non-adherence questions from Voils, C.I et al. will be used to measure medication adherence, which will be used to assess self-management health behaviors.

The tool will be used to measure nutrition from eating, which will be used to assess self-management health behaviors.

The Food Frequency Questionnaire (FFQ) will be used to measure nutrition as related to food frequency, which will be used to assess self-management health behaviors.

AUDIT-C questionnaire will measure alcohol use, which will be used to assess self-management health behaviors.

Overall Health, 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity

The 12-Item Short-Form Health Survey will be used to measure overall health, which will be used to assess self-management health behaviors.

Food security will be measured using the United States Department of Agriculture, Economic Research Service. U.S. Household Food Security Survey Module: Six- Item Short Form.

The publication, "Outcome measures for health education and other health care interventions" by Lorig, Kate; Stewart, Anita; Ritter, Philip; Gonz lez, Virginia; et al. will be used to confidence in communication with providers.

Self Management Behaviors to control blood pressure will be measured by questions taken from the Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2009

Utilization of neighborhood resources will be assessed using the Chronic Illness Resources Survey: Cross-validation and sensitivity to intervention.

Patient Mental Health will be measured using the PHQ-8: A New Depression Diagnostic and Severity Measure

Health literacy will be measured using questions taken from the article, Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep; 36(8):588-94.

Inclusion Criteria: Must be a Veteran Have > 1 visit to VA Puget Sound Health Care Center(Seattle or American Lake VA) primary care or women's clinic in the past year Poorly controlled hypertension (> 150/90 mmHg) At least one other CVD risk (including overweight or obesity, body mass index > 25 kg/m2, tobacco use, hyperlipidemia LDL-c > 130 mg/dL) Exclusion Criteria: Hospitalization in the past 3 months for cardiovascular-related conditions (IHD, Cerebral Vascular Accident [CVA], PVD) Severe illness that precludes lifestyle program, end-stage renal disease (ESRD) on dialysis Nursing home resident, homeless Severe cognitive impairment Receiving home-based primary care (including VA Home Tele-Health and patients who received palliative care or are enrolled in hospice care)

We will adhere to all VA 1200.12 policies to protect individual privacy & confidentiality of data. Data will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted & evaluated by the VA Puget Sound FOIA Officer, or as passed down to the facility. A unique study ID will label all data records to allow validation of results, but prevent data from being linked to individuals. Records across data sets can be cross-referenced using the study ID to verify accuracy of publication results. Research publications will be made available to the public via the National Library of Medicine PubMed Central website within one year after publication date(s). A Limited Dataset will be created & shared pursuant a Data Use Agreement that appropriately limits use of the dataset & prohibits recipients from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Nelson K, Fennell T, Gray KE, Williams JL, Lutton MC, Silverman J, Jain K, Augustine MR, Kopf W, Taylor L, Sayre G, Vanderwarker C. Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks. Contemp Clin Trials. 2018 Oct;73:61-67. doi: 10.1016/j.cct.2018.08.011. Epub 2018 Aug 29.