The Effectiveness of Personalized Stroke Risk Communication

Stroke Clinical Trial

— RiskCom  

Official title:

The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178060
• Other study ID #: RRP 08-240
• Status: Completed
• Phase: N/A
• First received: August 6, 2010
• Last updated: August 20, 2010
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2010
• Source: Durham VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Stroke

Intervention

Other:
• Personalized Heart Attack and Stroke Risk
Personalized assessment of heart attack and stroke risk based on 10yr predictors with individual risk factors.
• Standard Education
Patients received a general handout describing risk factors for heart attack and stroke.

Locations

Country	Name	City	State
United States	Durham VA Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Durham VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of personalized risk information	Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.	baseline	No
Primary	Impact of personalized risk information	Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.	3 month	No
Secondary	Evaluate impact on medication adherence	Evaluate the impact of personalized risk communication on medication adherence at 3-months	3-months	No