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

NCT03935282CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Wake Forest University Health Sciences

Enrollment

600

Start Date

2020-10-01

Completion Date

2025-03-07

Study Type

INTERVENTIONAL

Official Title

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

Interventions

AH-HA Tool in the EPIC EHR

Conditions

Breast NeoplasmProstatic NeoplasmColorectal NeoplasmsEndometrial NeoplasmsHodgkin DiseaseNon Hodgkin Lymphoma

Eligibility

Age Range

18 Years+

Sex

ALL

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.

Outcome Measures

Primary Outcomes

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

Secondary Outcomes

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

Locations

Mercy Hospital Fort Smith, Fort Smith, United States

Oncology Associates at Mercy Medical Center, Cedar Rapids, United States

Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, United States

Mercy Hospital Springfield, Springfield, United States

Mercy Hospital Saint Louis, St Louis, United States

Mercy Hospital Oklahoma City, Oklahoma City, United States

Community Medical Center, Scranton, United States

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, United States

Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, United States

Baptist Memorial Hospital for Women, Memphis, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, United States

ThedaCare Regional Cancer Center, Appleton, United States