Adapting Tools to Implement Stroke Risk Management to Veterans

Study Overview
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Brief Summary
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The purpose of this study is to develop and evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and evidence based guidelines for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider. We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.

Detailed Description
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Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the American Heart Association, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary Quality Enhancement Research Initiative work indicates that stroke risk factors are often undermanaged in the Veterans Health Administration. This proposed study of a stroke risk factor management program may benefit the Veteran Health System in several ways. First, it offers a systematic program for reduction in stroke risk factors leading to better health for our veterans and a reduction in inpatient and outpatient rehabilitation and home health services for these events. Second, the Veteran Stroke Prevention Program takes into account the varied resources and services offered in VAMCs across the nation, allowing the program to be tailored both to a given facility and to the individual veteran's needs and readiness to change. Importantly, the program could allow all VA facilities to offer guideline-concurrent stroke risk reduction programs and therefore increase compliance with VA/Department of Defense, American Heart Association, and the Joint Commission stroke care guidelines and improve their quality of stroke care. Comparison(s): We will compare two regionally matched facilities on rates of secondary stroke prevention guideline care during the course of the study at the intervention sites.

Official Title
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Adapting Tools to Implement Stroke Risk Management to Veterans

Conditions
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Ischemic Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Behavioral: Physician stroke guideline adherence
* Behavioral: Stroke Self Management
* Other: Attention Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans 18 years or older hospitalized with stroke or Transient Ischemic Attack at Indianapolis Veterans Administration Medical Center and Houston Veteran Administration Medical Center; willing to participate; access to telephone; speaks and understands English; no severe cognitive impairments; life expectancy of at least 6 mos; willingness to follow-up in Veterans Administration outpatient care. Exclusion Criteria: Severe aphasia or cognitive impairment; active alcohol or substance abuse; cannot or unwilling to participate; does not speak or understand English; life expectancy less than 6 mos; no access to telephone; no Veterans Administration outpatient follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Secondary Risk Factor Management<br>Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence | Behavioral: Physician stroke guideline adherence<br>* Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors<br>Behavioral: Stroke Self Management<br>* Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA<br>|
| Placebo Comparator: Attention Control Group<br>Received Phone Calls from Staff to Control for Attention | Other: Attention Control Group<br>* Received Phone Calls from Staff to Control for Attention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Specific Health Related Quality of Life | Stroke Specifc, Health Related Quality of Life (SSQoL) Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369. Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores. We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05. | 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain | 
| Self-Efficacy to Manage Stroke Symptoms | Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%) Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80% | baseline, 6 months | 
| Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%). Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%. | baseline, 6 months | 
| Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%) Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%. | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Preventive medicine, Transient Ischemic Attack, Neurology, Risk management