Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
NCT ID: NCT03935282
Last Updated: 2025-12-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
600 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-10-01
Study Completion Date
2025-11-17
Brief Summary
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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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Detailed Description
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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.
Conditions
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Breast Neoplasm
Prostatic Neoplasm
Colorectal Neoplasms
Endometrial Neoplasms
Hodgkin Disease
Non Hodgkin Lymphoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Intervention - AH-HA tool
With assistance from the study team, the clinic will implement the AH-HA tool in the clinics' EPIC EHR. Providers at the intervention sites will be trained to use the tool during routine follow-up care with survivors. During a routine follow-up care appointment, the provider will use the AH-HA tool with enrolled patients.
Group Type
EXPERIMENTAL
AH-HA Tool in the EPIC EHR
Intervention Type
OTHER
The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
Usual Care
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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AH-HA Tool in the EPIC EHR
The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
collaborator
University of Texas Southwestern Medical Center
OTHER
Sponsor Role
collaborator
Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Kathryn Weaver, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Site Status
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Site Status
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States
Site Status
Mercy Hospital Springfield
Springfield, Missouri, United States
Site Status
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Site Status
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Site Status
Community Medical Center
Scranton, Pennsylvania, United States
Site Status
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Site Status
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Site Status
Baptist Memorial Hospital for Women
Memphis, Tennessee, United States
Site Status
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Site Status
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Site Status
Countries
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United States
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Nightingale CL, Dressler EV, Kepper M, Klepin HD, Lee SC, Smith S, Aguilar A, Wiseman KD, Sohl SJ, Wells BJ, DeMari JA, Throckmorton A, Kulbacki LW, Hanna J, Foraker RE, Weaver KE. Oncology Provider and Patient Perspectives on a Cardiovascular Health Assessment Tool Used During Posttreatment Survivorship Care in Community Oncology (Results from WF-1804CD): Mixed Methods Observational Study. J Med Internet Res. 2025 Mar 6;27:e65152. doi: 10.2196/65152.
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DERIVED
Weaver KE, Dressler EV, Klepin HD, Lee SC, Wells BJ, Smith S, Hundley WG, Lesser GJ, Nightingale CL, Turner JC, Lackey I, Heard K, Foraker R; AH-HA Study Team. Effectiveness of a Cardiovascular Health Electronic Health Record Application for Cancer Survivors in Community Oncology Practice: Results From WF-1804CD. J Clin Oncol. 2025 Jan;43(1):46-56. doi: 10.1200/JCO.24.00342. Epub 2024 Nov 21.
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Weaver KE, Dressler EV, Smith S, Nightingale CL, Klepin HD, Lee SC, Wells BJ, Hundley WG, DeMari JA, Price SN, Foraker RE. Cardiovascular health assessment in routine cancer follow-up in community settings: survivor risk awareness and perspectives. BMC Cancer. 2024 Jan 31;24(1):158. doi: 10.1186/s12885-024-11912-8.
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DERIVED
DeMari JA, Dressler EV, Foraker RE, Wells BJ, Smith S, Klepin H, Hundley WG, Lesser GJ, Shalowitz DI, Nightingale CL, Hernandez M, Weaver KE. Endometrial cancer survivors' perceptions of their cardiovascular disease risk (results from WF-1804CD AH-HA). Gynecol Oncol. 2023 Jul;174:208-212. doi: 10.1016/j.ygyno.2023.05.009. Epub 2023 May 22.
Reference Type
DERIVED
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2019-01362
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2019-01362
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB00056774
Identifier Type: -
Identifier Source: org_study_id
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