Adapting Tools to Implement Stroke Risk Management to Veterans (TOOLS)

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Transient Ischemic Attack
• Intervention / Treatment: Behavioral: Physician stroke guideline adherence; Behavioral: Stroke Self Management; Other: Attention Control Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2884
      • Richard L. Roudebush VA Medical Center, Indianapolis, IN
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center, Houston, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 Secondary Risk Factor Management; Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence	Behavioral: Physician stroke guideline adherence; 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; Behavioral: Stroke Self Management; 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
Placebo Comparator: Attention Control Group; Received Phone Calls from Staff to Control for Attention	Other: Attention Control Group; Received Phone Calls from Staff to Control for Attention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Indiana University

Publications and helpful links

General Publications

• Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
• Damush TM, Jackson GL, Powers BJ, Bosworth HB, Cheng E, Anderson J, Guihan M, LaVela S, Rajan S, Plue L. Implementing evidence-based patient self-management programs in the Veterans Health Administration: perspectives on delivery system design considerations. J Gen Intern Med. 2010 Jan;25 Suppl 1(Suppl 1):68-71. doi: 10.1007/s11606-009-1123-5.
• Schmid AA, Andersen J, Kent T, Williams LS, Damush TM. Using intervention mapping to develop and adapt a secondary stroke prevention program in Veterans Health Administration medical centers. Implement Sci. 2010 Dec 15;5:97. doi: 10.1186/1748-5908-5-97.
• Damush TM, Myers L, Anderson JA, Yu Z, Ofner S, Nicholas G, Kimmel B, Schmid AA, Kent T, Williams LS. The effect of a locally adapted, secondary stroke risk factor self-management program on medication adherence among veterans with stroke/TIA. Transl Behav Med. 2016 Sep;6(3):457-68. doi: 10.1007/s13142-015-0348-6. Erratum In: Transl Behav Med. 2016 Sep;6(3):469.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 18, 2006
• First Submitted That Met QC Criteria: July 18, 2006
• First Posted (Estimate): July 21, 2006

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Ischemic stroke; Preventive medicine; Neurology; Transient Ischemic Attack; Risk management
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: IAB 05-297; 0608-01B (Other Grant/Funding Number: US Veterans Health Administration); 1009001684 (Other Grant/Funding Number: US Veterans Health Administration)