The Effectiveness of Personalized Stroke Risk Communication (RiskCom)
Primary Purpose
Cardiovascular Disease, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Heart Attack and Stroke Risk
Standard Education
Sponsored by

About this trial
This is an interventional health services research trial for Cardiovascular Disease focused on measuring Stroke, Risk, Communication, Cardiovascular Disease Knowledge, Improve Risk Communication
Eligibility Criteria
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
Sites / Locations
- Durham VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Personalized Risk Information
Standard Education
Arm Description
Patients received personalized stroke and heart attack risk assessment information.
Patients received general risk information on heart attack and stroke.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Evaluate impact on medication adherence
Evaluate the impact of personalized risk communication on medication adherence at 3-months
Full Information
NCT ID
NCT01178060
First Posted
August 6, 2010
Last Updated
August 20, 2010
Sponsor
Durham VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01178060
Brief Title
The Effectiveness of Personalized Stroke Risk Communication
Acronym
RiskCom
Official Title
The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Durham VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Stroke
Keywords
Stroke, Risk, Communication, Cardiovascular Disease Knowledge, Improve Risk Communication
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized Risk Information
Arm Type
Active Comparator
Arm Description
Patients received personalized stroke and heart attack risk assessment information.
Arm Title
Standard Education
Arm Type
Other
Arm Description
Patients received general risk information on heart attack and stroke.
Intervention Type
Other
Intervention Name(s)
Personalized Heart Attack and Stroke Risk
Intervention Description
Personalized assessment of heart attack and stroke risk based on 10yr predictors with individual risk factors.
Intervention Type
Other
Intervention Name(s)
Standard Education
Intervention Description
Patients received a general handout describing risk factors for heart attack and stroke.
Primary Outcome Measure Information:
Title
Impact of personalized risk information
Description
Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.
Time Frame
baseline
Title
Impact of personalized risk information
Description
Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Evaluate impact on medication adherence
Description
Evaluate the impact of personalized risk communication on medication adherence at 3-months
Time Frame
3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayden Bosworth, PhD
Organizational Affiliation
Durham VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21473965
Citation
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.
Results Reference
derived
Learn more about this trial
The Effectiveness of Personalized Stroke Risk Communication
We'll reach out to this number within 24 hrs