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

• ClinicalTrials.gov Identifier: NCT00355147
• Recruitment Status: Completed
• First Posted: July 21, 2006
• Results First Posted: February 10, 2015
• Last Update Posted: October 11, 2018
• Sponsor: VA Office of Research and Development
• Collaborator: Indiana University
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: July 18, 2006
• First Posted Date: July 21, 2006
• Results First Submitted Date: July 15, 2014
• Results First Posted Date: February 10, 2015
• Last Update Posted Date: October 11, 2018
• Study Start Date: January 2009
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2015)

• Stroke Specific Health Related Quality of Life [ Time Frame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain ]
  • 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.
• Self-Efficacy to Manage Stroke Symptoms [ Time Frame: 6 months ]
  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.

• Original Primary Outcome Measures (submitted: July 18, 2006): Provider based outcomes - guideline adherent treatment, medication management at stroke discharge, 3 and 6 mos. Risk factor screening, examination of CPRS records during hospitalization or following 6 mos. Lifestyle counseling, examination of CPRS record

Current Secondary Outcome Measures (submitted: March 10, 2015)

• Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment [ Time Frame: baseline, 6 months ]
  • 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%
• Medication (Statins) for Secondary Stroke Prevention Risk Factor Management [ Time Frame: baseline, 6 months ]
  • 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%.
• Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management [ Time Frame: Baseline, 6 months ]
  • 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%.

• Original Secondary Outcome Measures (submitted: July 18, 2006): Patient demographics, BL; depression symptoms at BL, 3 & 6 mos; other co morbidities at 6 mos.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adapting Tools to Implement Stroke Risk Management to Veterans
• Official Title: Adapting Tools to Implement Stroke Risk Management to Veterans

Brief 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Health Services Research

Condition

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

Study Arms

• 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
  Interventions:

  • Behavioral: Physician stroke guideline adherence
  • Behavioral: Stroke Self Management
• Placebo Comparator: Attention Control Group
  Received Phone Calls from Staff to Control for Attention
  Intervention: Other: Attention Control Group

Publications *

• 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, 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 1:68-71. doi: 10.1007/s11606-009-1123-5. Review.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2015): 174
• Original Enrollment (submitted: July 18, 2006): 327
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00355147
• 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 )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: VA Office of Research and Development
• Study Sponsor: VA Office of Research and Development
• Collaborators: Indiana University

Investigators

• Principal Investigator: Teresa M. Damush, PhD; Richard L. Roudebush VA Medical Center, Indianapolis, IN

• PRS Account: VA Office of Research and Development
• Verification Date: September 2018