Will Veterans Engage in Prevention After HRA-guided Shared Decision Making? (ACTIVATE)

September 7, 2018 updated by: VA Office of Research and Development
The VA has committed to disseminate a web-based Healthy Living Assessment(HLA) tool and use it as the cornerstone of a personalized prevention plan to engage patients to improve their health behaviors that lead to high health risk. Health risk assessments done in isolation, however, do not generally lead to behavior change. Our study will test the effectiveness of a Shared Decision Making intervention designed to activate Veterans to enroll in effective prevention programs. The intervention will be conducted over the telephone, by a prevention coach, and will be linked to the patients' primary care team. The co-primary outcomes will be patient activation and patient enrollment in prevention programs; 10-year risk of major cardiac events will also be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over half of all deaths, and many illnesses, can be attributed to four modifiable risk factors: tobacco use, overweight/obesity, physical inactivity, and alcohol use. There are clear links between these modifiable factors and heart disease, cancer, chronic lung disease, and stroke which continue to be the leading causes of death in the United States. Significant improvements have been made in controlling conditions that lead to heart disease, cancer and stroke (e.g., hypertension and hyperlipidemia). However, the underlying behavioral factors (e.g., obesity, tobacco use, and physical inactivity) have not been addressed as well. Prevention is particularly important for Veterans because of the high prevalence of significant risk factors for poor health. For example, more than 70% of Veterans Health Administration (VHA) patients are overweight (body mass index [BMI] 25kg/m2) and one-third are obese (BMI 30kg/m2), which is significantly higher than the US population. Smoking also remains a significant problem among Veterans, with VHA enrollment data from 2010 indicating a prevalence of 20%. Younger Veterans are at particularly high risk for developing chronic illnesses because they are more likely to be overweight/obese and smoke more heavily than non-Veterans.

The investigators propose a two-site, two-arm randomized trial measuring the effectiveness of a Shared Decision Making (SDM) intervention in activating Veterans to enroll in effective prevention services, and improve cardiovascular risk, compared to Veterans Administration (VA) usual care. The study will be performed at the Durham and Ann Arbor Veterans Administration Medical Centers (VAMCs). Each arm will have 225 patients; patients will be VA users with at least one modifiable risk factor (obese, inactive, or tobacco user) who are not currently enrolled in a prevention service. The SDM intervention will be conducted by a prevention coach, telephone based, and will use the output from VHA's Healthy Living Assessment (HLA) to engage Veterans in a conversation where individual preferences are matched to behaviors, and choices for specific prevention services. The resulting prevention action plan will be shared with the Veterans primary care team, and documented in the medical record.

Outcomes will be obtained at baseline, 1 month and 6 months after enrollment by blinded research personnel. The primary outcomes will be: 1) proportion enrolled in effective prevention services; and 2) change in the Patient Activation Measure (PAM). The secondary outcome is 10-year risk of coronary events, as measured by Framingham Risk Score (FRS). Process evaluations of the intervention and its implementation will also be conducted to inform future dissemination and implementation should it prove effective.

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center, Durham, NC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be included in the study, patients must meet the following:

  • enrolled in primary care at the Durham or Ann Arbor Health Care Systems
  • have one modifiable risk factor identified by a healthy living assessment (physical inactivity, overweight or obese by BMI, or tobacco user)

Exclusion Criteria:

Individuals will be excluded if they have any of the following:

  • have been hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past three months
  • have an active diagnosis of psychosis
  • have any other health condition they feel would impede participation in the study
  • reside in a nursing home
  • are severely impaired in hearing or speech, so that they cannot respond to telephone calls
  • have significant cognitive or memory impairment
  • do not have access to a telephone
  • are participating in another prevention intervention study
  • are already enrolled in a formal prevention service

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Experimental: Intervention
Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment
Behavioral: Shared decision making with a Prevention Coach
A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to Patient Aligned Care Team (PACT), and a follow-up call one month later to assess the progress of the prevention plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment in Prevention Services
Time Frame: 1 and 6 months (cumulative)
Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.
1 and 6 months (cumulative)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Activation Measures (PAM)
Time Frame: Baseline assessment
Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
Baseline assessment
Patient Activation Measures
Time Frame: 1 month assessment
Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
1 month assessment
Patient Activation Measures
Time Frame: 6 months assessments
Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
6 months assessments
Framingham Risk Score
Time Frame: Baseline
The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.
Baseline
Framingham Risk Score
Time Frame: 6 months
The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Principal Investigator: Eugene Z. Oddone, MD MHSc, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 30, 2016

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 12-288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified, anonymized dataset will be created and shared. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD.

A local privacy officer and study statistician will certify that the dataset contains no PHI prior to distribution. Data will be provided to requestor in electronic form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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