Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)
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|ClinicalTrials.gov Identifier: NCT03935282|
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2019
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Prostatic Neoplasm Colorectal Neoplasms Endometrial Neoplasms Hodgkin Disease Non Hodgkin Lymphoma||Other: AH-HA Tool in the EPIC EHR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)|
|Actual Study Start Date :||May 21, 2019|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2023|
Experimental: Intervention - AH-HA tool
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.
Other: AH-HA Tool in the EPIC EHR
The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
No Intervention: Usual Care
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
- Proportion of patients reporting 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.
- Number of referrals to primary care and cardiology to manage CV risk [ Time Frame: 1 year ]Medical chart abstraction of referrals and communication with providers regarding CVH at each survivor visit.
- Number of CVH-relevant labs and treatments to manage CV risk [ Time Frame: 1 year ]Medical chart abstraction.
- Completed visits with primary care providers and cardiology [ Time Frame: 1 year ]Medical chart abstraction of referrals and communication with providers regarding CVH at each survivor visit.
- CVH behaviors recorded in the past year [ Time Frame: 1 year ]Medical chart abstraction; Patient survey as secondary, verification source. Measured using smoking status, BMI, physical activity, and healthy diet.
- CVH factors recorded in the past year [ Time Frame: 1 year ]Medical chart abstraction; Patient survey as secondary, verification source. Measured using total cholesterol, blood pressure, and fasting plasma glucose/Alc.
- Patient perception and knowledge of CV risks [ Time Frame: Baseline, 6 months, 1 year ]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.
- Proportion of survivors for whom AH-HA is utilized [ Time Frame: 1 year ]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.
- Measure of tool acceptability with Tool Assessment [ 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. Patients will respond to 5 questions on a scale from strongly agree to strongly disagree.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935282
|United States, North Carolina|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Kathryn Weaver, MD||Wake Forest University Health Sciences|