Adapting Tools to Implement Stroke Risk Management to Veterans

Ischemic Stroke Clinical Trial

— TOOLS  

Official title:

Adapting Tools to Implement Stroke Risk Management to Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355147
• Other study ID #: IAB 05-297
• Secondary ID: 0608-01B10090016
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

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
• 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

Other:
• Attention Control Group
Received Phone Calls from Staff to Control for Attention

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 considerati — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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