AH-HA EHR Tool for Heart Health in Cancer Survivors

(AH-HA Trial)

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cancer recurrence, Active surveillance, Language barrier, Other protocol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

645 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, ongoing hormonal therapies like tamoxifen or aromatase inhibitors are allowed.

What data supports the effectiveness of the AH-HA Tool treatment for heart health in cancer survivors?

The research suggests that using electronic health records (EHRs) and informatics tools can help manage heart health in cancer survivors by integrating data to predict and monitor cardiovascular risks, which is similar to the approach used by the AH-HA Tool. ^{1 2 3 4 5}

How is the AH-HA EHR tool treatment different from other treatments for heart health in cancer survivors?

The AH-HA EHR tool is unique because it uses an electronic health record-based system to support clinical decisions specifically for cancer survivors, focusing on improving cardiovascular health discussions and referrals. Unlike traditional treatments, it emphasizes virtual visits and data collection, which is particularly beneficial during disruptions like the COVID-19 pandemic. ^{1 2 4 6 7}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants provide baseline data before and immediately after seeing their oncology provider

1 week

1 visit (in-person)

Intervention

Providers at intervention sites are trained to use the AH-HA tool during routine follow-up care with survivors

1 year

Routine follow-up visits

Follow-up

Participants complete 6-month and 1-year study follow-up visits to assess changes in cardiovascular health outcomes

1 year

2 visits (in-person)

Treatment Details

Interventions

• AH-HA Tool in the EPIC EHR

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+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Findings from Research

The pilot study involving 23 female breast cancer survivors demonstrated that an app-based interactive care plan (ICP) was feasible, allowing for remote monitoring and symptom management, although patient engagement fell short of the desired 75% completion rate for tasks.

Despite the initial feasibility, with all patients engaging in at least one task, the decreasing completion rates over time indicate a need for strategies to improve ongoing patient engagement and enhance the effectiveness of the ICP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot implementation to assess the feasibility and care team impact of an app-based interactive care plan to remotely monitor breast cancer survivors. Stan, DL., Inselman, JW., Ridgeway, JL., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot implementation to assess the feasibility and care team impact of an app-based interactive care plan to remotely monitor breast cancer survivors. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Electronic Health Records-Based Cardio-Oncology Registry for Care Gap Identification and Pragmatic Research: Procedure and Observational Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Risk and Breast Cancer Outcomes: A Pilot Study. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Informatics tools to implement late cardiovascular risk prediction modeling for population management of high-risk childhood cancer survivors. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Individual prediction of heart failure among childhood cancer survivors. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Survivor and Clinician Assessment of Survivorship Care Plans for Hematopoietic Stem Cell Transplantation Patients: An Engineering, Primary Care, and Oncology Collaborative for Survivorship Health. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing cancer survivors' cardiovascular health using the automated heart health assessment (AH-HA) EHR tool: Initial protocol and modifications to address COVID-19 challenges. [2022]