Breast Cancer Clinical Trial

Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors

Summary

The objective of this hybrid effectiveness-implementation study is to examine the effects of an EHR-based cardiovascular health assessment tool (AH-HA) among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors (N=600) receiving survivorship care in community oncology practices, using a group-randomized trial design (6 intervention practices and 6 usual care practices). Our central hypothesis is that the AH-HA tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) referrals and visits to primary care and cardiology (care coordination), and (3) cardiovascular (CV) risk reduction and health promotion activities compared to usual care.

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Full Description

In this hybrid effectiveness-implementation group-randomized clinical trial, 6 intervention practices will receive an EHR-based cardiovascular health assessment tool (Automated Heart Health Assessment for Survivors: AH-HA) and 6 practices will serve as usual care (control) practices without access to the AH-HA tool. AH-HA renders a visual, interactive display of CVH risk factors, automatically populated from the EHR. This tool was first implemented in primary care and now incorporates EHR data on receipt of cancer treatments with cardiotoxic potential. Providers at each intervention site will be trained to use the tool during routine follow-up care with survivors. Eligible survivors with breast, prostate, colorectal, endometrial, or Hodgkin and non-Hodgkin lymphoma cancer (n=600) will provide baseline data before and immediately after seeing their oncology provider and complete 6-month and 1-year study follow-up visits. The study team will compare changes in outcomes from baseline to 1-year in survivors at the intervention and usual care clinics using data from survivor self-reports and the EHR. The primary outcome is CVH discussions defined as the number of patient-reported discussions with their provider regarding up to seven non-ideal CVH conditions identified for that patient during oncology visits. Secondary outcomes include referrals to primary care and cardiology, provider efforts to manage CV risk, survivors' completed visits with primary care providers and cardiologists, and control of CVH factors and behaviors. Implementation metrics will be assessed using data from the EHR and semi-structured interviews with providers and administrators (n=24-30) at intervention clinics.

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Eligibility Criteria

Inclusion Criteria:

>= 6 months post-potentially curative cancer treatment for breast, prostate, colorectal, or endometrial cancers or Hodgkin and non-Hodgkin lymphomas. Ongoing hormonal therapies such as tamoxifen, aromatase inhibitors (with or without adjuvant CDK 4/6 inhibitors such as abemaciclib), or androgen deprivation are allowed.
Scheduled for a routine cancer-related follow-up care visit within the next 30 days with a provider who received training to use AH-HA.
Able and willing to complete a follow-up assessment in one year.
Survivors must have no evidence of disease at the time of last medical visit for all cancers, except non-melanoma skin disease.
Age >= 18 years.
Able to understand and willing to provide verbal informed consent.

Exclusion Criteria:

Survivors will be excluded if they have a history of cancer recurrence for any cancer other than non-melanoma skin disease.
Prostate patients on active surveillance will be excluded.
Survivor does not speak English or Spanish.
Survivors who are currently on another interventional protocol in which cardiovascular risk factors (e.g., blood pressure, smoking, diet, physical activity) are being addressed, as per patient self-report or research staff members' knowledge at the time of consent.

Study is for people with:

Breast Cancer

Estimated Enrollment:

640

Study ID:

NCT03935282

Recruitment Status:

Enrolling by invitation

Sponsor:

Wake Forest University Health Sciences

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There are 10 Locations for this study

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Mercy Hospital Fort Smith
Fort Smith Arkansas, 72903, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin Missouri, 63011, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
Mercy Hospital Oklahoma City
Oklahoma City Oklahoma, 73120, United States
Community Medical Center
Scranton Pennsylvania, 18510, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis Tennessee, 38120, United States
Baptist Memorial Hospital for Women
Memphis Tennessee, 38120, United States
ThedaCare Regional Cancer Center
Appleton Wisconsin, 54911, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

640

Study ID:

NCT03935282

Recruitment Status:

Enrolling by invitation

Sponsor:


Wake Forest University Health Sciences

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