Skip to main content
OpenTrials
Completed

NCT Number: NCT03935282

Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasm Behavior Breast Diseases Breast Neoplasms Cardiovascular Diseases Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Health Behavior Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non Hodgkin Lymphoma Prostatic Diseases Prostatic Neoplasm Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AH-HA Tool in the EPIC EHR

Other

The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.

Primary outcomes

  1. Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic

    Time frame: Baseline

    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.

Secondary outcomes

  1. Referrals to Primary Care to Manage CV Risk

    Time frame: Baseline

    Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.

  2. Referrals to Cardiology to Manage CV Risk

    Time frame: Baseline

    Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.

  3. Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test

    Time frame: Baseline

    Medical chart abstraction.

  4. Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test

    Time frame: Baseline

    Medical chart abstraction.

  5. Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test

    Time frame: Baseline

    Medical chart abstraction.

  6. Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication

    Time frame: Baseline

    Medical chart abstraction.

  7. Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication

    Time frame: Baseline

    Medical chart abstraction.

  8. Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication

    Time frame: Baseline

    Medical chart abstraction.

  9. Any Completed Visits With Primary Care Providers

    Time frame: 1 year

    Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit

  10. Any Completed Visits With Cardiology Providers

    Time frame: 1 year

    Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit

  11. Change in CVH Behaviors Recorded in the Past Year: Smoking Status

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Proportion of participants who were non-smoking at 1-year, of those who were smoking at baseline.

  12. Change in CVH Behaviors Recorded in the Past Year: BMI

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in BMI from baseline to 1-year.

  13. Change in CVH Behaviors Recorded in the Past Year: Physical Activity

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in total minutes of physical activity per week from baseline to 1-year.

  14. Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in healthy diet score from baseline to 1-year. Healthy diet score is calculated from the sum of 5 diet questions (range: 0-5) with higher scores indicating a healthier diet.

  15. Change in CVH Factors Recorded in the Past Year: Total Cholesterol

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in total cholesterol from baseline to 1-year.

  16. Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in systolic blood pressure l from baseline to 1-year.

  17. Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in diastolic blood pressure l from baseline to 1-year.

  18. Change in CVH Factors Recorded in the Past Year: A1c

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in A1c from baseline to 1-year.

  19. Change in CVH Factors Recorded in the Past Year: Glucose

    Time frame: 1 year

    Medical chart abstraction; Patient survey as secondary, verification source. Change in glucose from baseline to 1-year.

  20. Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  21. Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  22. Patient Perception and Knowledge of CV Risks: I Plan to Take Steps to Maintain or Improve my Heart Health Within the Next Year

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  23. Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  24. Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  25. Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  26. Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Primary Care Provider About my Heart Health

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  27. Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health

    Time frame: Baseline

    Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.

  28. Proportion of Survivors for Whom AH-HA is Utilized

    Time frame: Baseline

    We will capture the number of eligible patient visits during which the AH-HA tool was used in intervention clinics and the total number of eligible visits to calculate the proportion of patients where AH-HA was utilized.

  29. Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider

    Time frame: Baseline

    In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.

  30. Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score

    Time frame: Baseline

    In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.

  31. Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand

    Time frame: Baseline

    In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.

  32. Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health

    Time frame: Baseline

    In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.

  33. 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

    Time frame: Baseline

    In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Texas Southwestern Medical Center
  • Washington University School of Medicine

Registry information

Official study title

Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)

Acronym: AH-HA

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 2, 2019
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.