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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828567
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Health Risk Appraisal Heart Disease Prevention Behavioral: Shared decision making with a Prevention Coach Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : December 30, 2017

Arm Intervention/treatment
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.

No Intervention: Control
Usual care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828567


Locations
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United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Eugene Z. Oddone, MD MHSc Durham VA Medical Center, Durham, NC
Principal Investigator: Laura J. Damschroder, MPH VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01828567    
Other Study ID Numbers: CRE 12-288
First Posted: April 10, 2013    Key Record Dates
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.


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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
Keywords provided by VA Office of Research and Development:
veterans
health risk assessment
primary prevention
shared decision making
Healthy Living Assessment
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases