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
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
600
The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
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
Proportion of patients reporting 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
Number of referrals to primary care and cardiology to manage CV risk
Medical chart abstraction of referrals and communication with providers regarding CVH at each survivor visit.
Time frame: 1 year
Number of CVH-relevant labs and treatments to manage CV risk
Medical chart abstraction.
Time frame: 1 year
Completed visits with primary care providers and cardiology
Medical chart abstraction of referrals and communication with providers regarding CVH at each survivor visit.
Time frame: 1 year
CVH behaviors recorded in the past year
Medical chart abstraction; Patient survey as secondary, verification source. Measured using smoking status, BMI, physical activity, and healthy diet.
Time frame: 1 year
CVH factors recorded in the past year
Medical chart abstraction; Patient survey as secondary, verification source. Measured using total cholesterol, blood pressure, and fasting plasma glucose/Alc.
Time frame: 1 year
Patient perception and knowledge of CV risks
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.Minimum score is 0, maximum score is 3 and answer is the total number of questions where a patient responded agree or strongly agree.
Time frame: Baseline, 6 months, 1 year
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: 1 year
Measure of tool acceptability with Tool Assessment
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. Patients will respond to 5 questions on a scale from strongly agree to strongly disagree.
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.