Clinical trial NCT03935282: Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
Official title: Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Prostatic Neoplasm
Colorectal Neoplasms
Endometrial Neoplasms
Hodgkin Disease
Non Hodgkin Lymphoma
Keywords: Cardiovascular risk
Cardiovascular disease
Cancer
Survivor
Health Behaviors
Oncology Providers
EHR
Informatics
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Washington University School of Medicine
name: University of Texas Southwestern Medical Center
First posted: 2019-05-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients reporting at least one non-ideal or missing CVH topic
timeFrame: Baseline
Secondary outcomes:
measure: Number of referrals to primary care and cardiology to manage CV risk
timeFrame: 1 year
measure: Number of CVH-relevant labs and treatments to manage CV risk
timeFrame: 1 year
measure: Completed visits with primary care providers and cardiology
timeFrame: 1 year
measure: CVH behaviors recorded in the past year
timeFrame: 1 year
measure: CVH factors recorded in the past year
timeFrame: 1 year
measure: Patient perception and knowledge of CV risks
timeFrame: Baseline, 6 months, 1 year
measure: Proportion of survivors for whom AH-HA is utilized
timeFrame: 1 year
measure: Measure of tool acceptability with Tool Assessment
timeFrame: Baseline
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Mercy Hospital Fort Smith
state: Arkansas
city: Cedar Rapids
country: United States
facility: Oncology Associates at Mercy Medical Center
state: Iowa
city: Ballwin
country: United States
facility: Saint Louis Cancer and Breast Institute-Ballwin
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City
state: Oklahoma
city: Scranton
country: United States
facility: Community Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley/Henry Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Memphis
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital for Women
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn Weaver, MD
role: PRINCIPAL_INVESTIGATOR
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