AH-HA EHR Tool for Heart Health in Cancer Survivors

(AH-HA Trial)

Recruiting at11 trial locations

Overseen by Kathryn Weaver, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kathryn Weaver, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 who are cancer survivors (specifically of breast, prostate, colorectal, endometrial cancers or Hodgkin and non-Hodgkin lymphomas) with no current evidence of disease. They must understand English or Spanish, consent verbally to participate, be able to complete a follow-up in one year and have finished curative treatment at least 6 months ago.

Inclusion Criteria

Able and willing to complete a follow-up assessment in one year.

I am 18 years old or older.

I have a cancer follow-up visit within 30 days with an AH-HA trained provider.

Exclusion Criteria

I have not had a cancer recurrence except for non-melanoma skin cancer.

You are currently participating in another study that focuses on improving heart health through factors like blood pressure, smoking, diet, and physical activity.

I do not speak English or Spanish.

Treatment Details

Interventions

• AH-HA Tool in the EPIC EHR (Behavioural Intervention)

Trial Overview The study tests an electronic health record tool called AH-HA designed to improve heart health discussions between patients and doctors. It will also look at whether the tool helps increase referrals to primary care/cardiology and promotes activities that reduce cardiovascular risk among cancer survivors.

Participant Groups

Group I: Intervention - AH-HA tool Experimental Treatment 1 Intervention

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 II: Usual Care Active Control 1 Intervention

Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine