Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
AH-HA
3 other identifiers
interventional
645
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
May 2, 2019
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2025
CompletedResults Posted
Study results publicly available
April 15, 2026
CompletedApril 15, 2026
March 1, 2026
4.4 years
April 11, 2019
January 29, 2026
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic
Discussion of non-ideal cardiovascular health (CVH) factors (yes or no). CVH discussions will be defined as patient-reported discussions with their provider for any of the seven non-ideal CVH conditions identified for that patient. Conditions include CVH factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors (body mass index, smoking, diet, and physical activity). Measured using survivor survey (discussions, diet, and primary care) and EHR for other CVH factors.
Baseline
Secondary Outcomes (33)
Referrals to Primary Care to Manage CV Risk
Baseline
Referrals to Cardiology to Manage CV Risk
Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test
Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test
Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test
Baseline
- +28 more secondary outcomes
Study Arms (2)
Intervention - AH-HA tool
EXPERIMENTALWith 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.
Usual Care
NO INTERVENTIONUsual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Interventions
The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
Eligibility Criteria
You may qualify if:
- \>= 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- National Cancer Institute (NCI)collaborator
- Washington University School of Medicinecollaborator
- University of Texas Southwestern Medical Centercollaborator
Study Sites (12)
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 Springfield
Springfield, Missouri, 65804, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, 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
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
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PMID: 37224793DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Dressler
- Organization
- NCORP
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn Weaver, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2019
First Posted
May 2, 2019
Study Start
October 1, 2020
Primary Completion
March 7, 2025
Study Completion
November 17, 2025
Last Updated
April 15, 2026
Results First Posted
April 15, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration.
- Access Criteria
- upon request to NCORP@wakehealth.edu
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.