EHR Tool in Assessing Heart Health among Cancer Survivors

Active:	Yes
Cancer Type:	Breast Cancer Colon/Rectal Cancer Hematopoietic Malignancies Hodgkin Lymphoma Lymphoma Non-Hodgkin Lymphoma Prostate Cancer Solid Tumor Unknown Primary Uterine Cancer	NCT ID:	NCT03935282
Trial Phases:		Protocol IDs:	WF-1804CD (primary) WF-1804CD WF-1804CD NCI-2019-01362
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	Wake Forest NCORP Research Base
NCI Full Details:	http://clinicaltrials.gov/show/NCT03935282

Summary

The objective of this hybrid effectiveness-implementation study is to examine the effects of an electronic health record (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.

Objectives

PRIMARY OBJECTIVE:
I. Assess the impact of the AH-HA tool on providers’ efforts to discuss cardiovascular health (CVH) during visits as compared to usual care.

SECONDARY OBJECTIVES:
I. Assess the impact of the AH-HA tool on providers’ efforts to: (1) refer survivors to primary care and cardiology, and (2) manage CV risk (ordering of CVH-relevant labs and treatments), using data from survivor (N=600) reports and the EHR at baseline, 6 months, and one year after enrollment.
II. Measure the impact of the AH-HA tool on survivors’: (1) completed visits with primary care providers and cardiologists, (2) control of CVH factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors (body mass index, smoking, diet, and physical activity), (3) perception of CV risk and knowledge of CVH factors, and 4) satisfaction with care using data from survivor (N=600) reports and the EHR at baseline, six months, and one year after enrollment.
III. Examine factors influencing current and future implementation of the AH-HA tool.
IIIa. Assess reach of the AH-HA tool in community oncology practices using EHR data (proportion and characteristics of survivors for whom AH-HA is utilized in clinic).
IIIb. Identify potential barriers and facilitators to “real-world” delivery of the intervention and ascertain potential modifications to maximize adoption, implementation, and maintenance by collecting data from providers and practice administrative leaders via semi-structured interviews.

OUTLINE: Participating oncology practices are randomized to 1 of 2 groups.
Survivors complete surveys before and after the survivorship visit and again at 6 months and 1 year.

GROUP I: Community oncology practices use the AH-HA tool as part of routine cancer-related follow-up care.

GROUP II: Survivors receive usual care.

Treatment Sites in Georgia

Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.