N/A
N=645
Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
Breast Neoplasm · Prostatic Neoplasm · Colorectal Neoplasms · Endometrial Neoplasms · Hodgkin Disease
Bottom Line
View on ClinicalTrials.gov: NCT03935282 ↗Enrolled (actual)
645
Serious AEs
—
Results posted
Apr 2026
Primary outcome: Primary: Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic — 96.2; 52.2 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AH-HA Tool in the EPIC EHR (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic |
96.2; 52.2 | <0.0001 sig |
| SECONDARY Referrals to Primary Care to Manage CV Risk |
28.7; 24.8 | 0.6946 |
| SECONDARY Referrals to Cardiology to Manage CV Risk |
2.9; 2.9 | 0.9921 |
| SECONDARY Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test |
25; 0 | <0.0001 sig |
| SECONDARY Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test |
19; 49 | 0.0016 sig |
| SECONDARY Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test |
22; 1 | <.0001 sig |
| SECONDARY Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication |
3; 3 | 1.00 |
| SECONDARY Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication |
0; 1 | 1.00 |
| SECONDARY Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication |
3; 3 | 1.00 |
| SECONDARY Any Completed Visits With Primary Care Providers |
63.2; 74.5 | 0.1819 |
| SECONDARY Any Completed Visits With Cardiology Providers |
5.3; 16.2 | 0.0020 sig |
| SECONDARY Change in CVH Behaviors Recorded in the Past Year: Smoking Status |
47.1; 13.1 | 0.1708 |
| SECONDARY Change in CVH Behaviors Recorded in the Past Year: BMI |
-0.98; 0.97 | 0.0702 |
| SECONDARY Change in CVH Behaviors Recorded in the Past Year: Physical Activity |
-32.8; 23.9 | 0.3478 |
| SECONDARY Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score |
0.5; 0.4 | 0.4529 |
| SECONDARY Change in CVH Factors Recorded in the Past Year: Total Cholesterol |
-1.3; -0.4 | 0.8037 |
| SECONDARY Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure |
0.1; -0.2 | 0.7832 |
| SECONDARY Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure |
-0.8; -0.4 | 0.5697 |
| SECONDARY Change in CVH Factors Recorded in the Past Year: A1c |
-0.2; 0.3 | 0.0827 |
| SECONDARY Change in CVH Factors Recorded in the Past Year: Glucose |
6.3; 4.4 | 0.7317 |
| SECONDARY Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease |
61.3; 42.0 | 0.0765 |
| SECONDARY Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health |
80.8; 54.9 | 0.0285 sig |
| SECONDARY Patient Perception and Knowledge of CV Risks: I Plan to Take Steps to Maintain or Improve my Heart Health Within the Next Year |
79.2; 49.5 | 0.0845 |
| SECONDARY Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health |
33.4; 45.0 | 0.1108 |
| SECONDARY Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health |
57.1; 31.8 | 0.0011 sig |
| SECONDARY Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health |
61.6; 24.7 | <0.0001 sig |
| SECONDARY Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Primary Care Provider About my Heart Health |
63.3; 67.9 | 0.6513 |
| SECONDARY Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health |
63.4; 23.7 | 0.0006 sig |
| SECONDARY Proportion of Survivors for Whom AH-HA is Utilized |
245 | — |
| SECONDARY Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider |
231 | — |
| SECONDARY Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score |
229 | — |
| SECONDARY Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand |
228 | — |
| SECONDARY Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health |
204 | — |
| SECONDARY Measure of Tool Acceptability With Tool Assessment: I Would Like to Use This Tool to Talk About my Heart Health With my Oncology Provider at a Future Appointment |
208 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03935282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.