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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared decision making with a Prevention Coach | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment in Prevention Services | Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs. | 1 and 6 months (cumulative) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measures (PAM) | 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 |
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Inclusion Criteria:
To be included in the study, patients must meet the following:
Exclusion Criteria:
Individuals will be excluded if they have any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States | ||
| Durham VA Medical Center, Durham, NC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28126455 | Result | Oddone EZ, Damschroder LJ, Gierisch J, Olsen M, Fagerlin A, Sanders L, Sparks J, Turner M, May C, McCant F, Curry D, White-Clark C, Juntilla K. A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:1-9. doi: 10.1016/j.cct.2017.01.007. Epub 2017 Jan 24. | |
| 29736750 |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment 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 PACT, and a follow-up call one month later to assess the progress of the prevention plan. |
| FG001 | Control | Usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment 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 PACT, and a follow-up call one month later to assess the progress of the prevention plan. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment in Prevention Services | Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs. | Unknowns were removed from the denominator: Intervention n=29; control n=15. | Posted | Number | participants | 1 and 6 months (cumulative) |
|
Through study completion, an average of 6 months.
Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment 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 PACT, and a follow-up call one month later to assess the progress of the prevention plan. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study Safety Protocol | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugene Z Oddone, MD, MPSc | Durham VA Center of Innovation in Primary Care | 919-286-0411 | eugene.oddone@va.gov |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| Baseline assessment |
| Patient Activation Measures | 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 | 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 | 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 | 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 |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Result |
| Oddone EZ, Gierisch JM, Sanders LL, Fagerlin A, Sparks J, McCant F, May C, Olsen MK, Damschroder LJ. A Coaching by Telephone Intervention on Engaging Patients to Address Modifiable Cardiovascular Risk Factors: a Randomized Controlled Trial. J Gen Intern Med. 2018 Sep;33(9):1487-1494. doi: 10.1007/s11606-018-4398-6. Epub 2018 May 7. |
| 32913914 | Derived | Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep. |
| 31898118 | Derived | Sloan C, Stechuchak KM, Olsen MK, Oddone EZ, Damschroder LJ, Maciejewski ML. Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial. J Gen Intern Med. 2020 May;35(5):1452-1457. doi: 10.1007/s11606-019-05455-z. Epub 2020 Jan 2. |
| 30756302 | Derived | Nouri SS, Damschroder LJ, Olsen MK, Gierisch JM, Fagerlin A, Sanders LL, McCant F, Oddone EZ. Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE. J Gen Intern Med. 2019 Apr;34(4):552-558. doi: 10.1007/s11606-019-04861-7. Epub 2019 Feb 12. |
| BG001 | Control | Usual care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Control |
Usual care |
|
|
|
| Secondary | Patient Activation Measures (PAM) | 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 | Posted | Mean | Standard Deviation | average score | Baseline assessment |
|
|
|
| Secondary | Patient Activation Measures | 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 | Posted | Mean | Standard Deviation | average score | 1 month assessment |
|
|
|
|
| Secondary | Patient Activation Measures | 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 | Posted | Mean | Standard Deviation | average score | 6 months assessments |
|
|
|
|
| Secondary | Framingham Risk Score | 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. | Unknowns were removed from the denominator: Intervention n=7; control n=2. | Posted | Mean | Standard Deviation | average score | Baseline |
|
|
|
| Secondary | Framingham Risk Score | 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. | Unknowns were removed from the denominator: Intervention n=22; control n=18. | Posted | Mean | Standard Deviation | average score | 6 months |
|
|
|
|
| 65 |
| 208 |
| 0 |
| 208 |
| EG001 | Control | Usual care | 53 | 209 | 0 | 209 |
| Hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Study Safety Protocol | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Important Medical Event | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization | Endocrine disorders | Non-systematic Assessment |
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| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hospitalization | General disorders | Non-systematic Assessment |
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| Hospitalization | Hepatobiliary disorders | Non-systematic Assessment |
|
| Protocol Deviation | Investigations | Non-systematic Assessment |
|
| Hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Emergency Room Visit | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Important Medical Event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Important Medical Event | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Important Medical Event | Psychiatric disorders | Non-systematic Assessment |
|
| Emergency Room Visit | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Important Medical Event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
|
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| Other |
| Equivalence |
This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model. |
This model assumes the groups have equal baseline means |