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

Wake Forest University Health Sciences645 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Community Medical Center

Scranton, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Baptist Memorial Hospital for Women

Memphis, Tennessee, United States

...and 2 more locations

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

Referrals to Primary Care to Manage CV Risk

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

Time frame: Baseline

Referrals to Cardiology to Manage CV Risk

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

Time frame: Baseline

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

Medical chart abstraction.

Time frame: Baseline

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

Medical chart abstraction.

Time frame: Baseline

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

Medical chart abstraction.

Time frame: Baseline

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

Medical chart abstraction.

Time frame: Baseline

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

Medical chart abstraction.

Time frame: Baseline

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

Medical chart abstraction.

Time frame: Baseline

Any Completed Visits With Primary Care Providers

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

Time frame: 1 year

Any Completed Visits With Cardiology Providers

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

Time frame: 1 year

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

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.

Time frame: 1 year

Change in CVH Behaviors Recorded in the Past Year: BMI

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

Time frame: 1 year

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

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

Time frame: 1 year

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

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.

Time frame: 1 year

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

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

Time frame: 1 year

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

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

Time frame: 1 year

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

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

Time frame: 1 year

Change in CVH Factors Recorded in the Past Year: A1c

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

Time frame: 1 year

Change in CVH Factors Recorded in the Past Year: Glucose

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

Time frame: 1 year

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

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.

Time frame: Baseline

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

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

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

Time frame: Baseline

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

Time frame: Baseline

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

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

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

Time frame: Baseline

Proportion of Survivors for Whom AH-HA is Utilized

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.

Time frame: Baseline

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

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.

Time frame: Baseline

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

Time frame: Baseline

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

Time frame: Baseline

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

Time frame: Baseline

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

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

Overview

Conditions

Interventions

Eligibility

Locations (12)

Outcomes

Primary Outcomes

Secondary Outcomes