The Effectiveness of Personalized Stroke Risk Communication (RiskCom)

This study has been completed.
Sponsor:
Information provided by:
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT01178060
First received: August 6, 2010
Last updated: August 20, 2010
Last verified: August 2010

August 6, 2010
August 20, 2010
September 2008
December 2009   (final data collection date for primary outcome measure)
  • Impact of personalized risk information [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.
  • Impact of personalized risk information [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.
Same as current
Complete list of historical versions of study NCT01178060 on ClinicalTrials.gov Archive Site
Evaluate impact on medication adherence [ Time Frame: 3-months ] [ Designated as safety issue: No ]
Evaluate the impact of personalized risk communication on medication adherence at 3-months
Same as current
Not Provided
Not Provided
 
The Effectiveness of Personalized Stroke Risk Communication
The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial

The goal of this research is to improve communication to Veterans. The investigators want to improve how doctors and nurses talk to patients about the risk of heart attack and stroke. The investigators will give everyone in the study information about the risk for heart attack or stroke. The investigators will also provide information on how to reduce this risk. This information will be given in one of two ways. The investigators want to see which way of giving information works better for veterans. The investigators also want to assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of personalized risk communication on medication adherence and blood pressure. The investigators plan to enroll approximately 100 veterans for this study. All veterans will be from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3 months.

Background:

In 2005, over 17,000 patients were treated for stroke within the VA with a cost of almost $315 million. Prevention of stroke through reduction of established risk factors is an essential part of the VA Stroke QUERI strategic plan for the VA. In spite of this, in the Veterans Affairs, only 13% of patients with known CVD achieve target BP and cholesterol control. Combining risk factors into a composite measure of risk offers a better global assessment of individual risk and is recommended by the American Heart Association and American Stroke Association for prioritizing interventions. This practice is rarely done in routine clinical practice and its use as a tool to motivate patient behavior has not been tested. Current evidence from VA patients suggests that patients with hypertension do not adequately translate their risk factors into an accurate estimation of stroke risk. Improving the accuracy of stroke risk perceptions may be particularly important in motivating risk reduction in patients.

Objectives:

The objectives of this study are to: 1.) Assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors. 2.) Evaluate the impact of personalized risk communication on medication adherence and blood pressure. 3.) Explore the feasibility and obtain sample size estimates for a larger, investigator initiative research (IIR) application testing this tool.

Methods:

A two-group randomized controlled trial testing a personalized risk communication intervention compared to an education-only control group was conducted. Eighty-nine patients were randomized and followed for 3months. Both groups received written and verbal patient education on stroke risk factors and prevention. Patients in the intervention arm also received personalized risk communication based on the Framingham stroke and coronary heart disease risk scores. A verbal and graphic presentation of their personal risk, risk relative to an age matched cohort, and their optimal or target risk based on optimal risk factor modification was presented. Outcomes measured immediately following the intervention and at 3months included: risk perception and worry; risk factor knowledge; decision preference and conflict; medication adherence; health behaviors; and blood pressure.

Status:

The study finished enrollment and all follow-up visits have been completed. The data from this project is being analyzed.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Cardiovascular Disease
  • Stroke
  • Other: Personalized Heart Attack and Stroke Risk
    Personalized assessment of heart attack and stroke risk based on 10yr predictors with individual risk factors.
  • Other: Standard Education
    Patients received a general handout describing risk factors for heart attack and stroke.
  • Active Comparator: Personalized Risk Information
    Patients received personalized stroke and heart attack risk assessment information.
    Intervention: Other: Personalized Heart Attack and Stroke Risk
  • Standard Education
    Patients received general risk information on heart attack and stroke.
    Intervention: Other: Standard Education
Powers BJ, Danus S, Grubber JM, Olsen MK, Oddone EZ, Bosworth HB. The effectiveness of personalized coronary heart disease and stroke risk communication. Am Heart J. 2011 Apr;161(4):673-80. doi: 10.1016/j.ahj.2010.12.021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrolled in a Durham VA Primary Care Clinic for at least one year
  • Age ≥ 55 years old
  • Diagnosis ICD 401.0, 401.1, or 401.9 on outpatient electronic encounter forms in the prior year
  • Received a prescription for hypertensive medication (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, alpha1 blockers, and/or central alpha2 agonists) in the previous year
  • Inadequate BP control based on an average of prior 12-month clinic BP measurements
  • Have a baseline EKG within the last 5 years to evaluate the presence of left ventricular hypertrophy.

Exclusion Criteria:

  • Hospitalized at the DVAMC for a myocardial infarction (MI), coronary artery revascularization, or diagnosis of metastatic cancer in the past 6 months
  • Prior history of stroke
  • Active diagnosis of psychosis or dementia documented in medical record
  • Participating in another chronic disease self-management study
  • Resident of a nursing home
  • Does not have access to a telephone
  • Refusal to provide informed consent
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01178060
RRP 08-240
No
Hayden Bosworth, PhD/Associate Director HSR&D and Benjamin Powers, MD/Co-I, Durham VA Medical Center
Durham VA Medical Center
Not Provided
Principal Investigator: Hayden Bosworth, PhD Durham VA Medical Center
Durham VA Medical Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP