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EHR Tool in Assessing Heart Health among Cancer Survivors

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

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.

Eligibility

  1. NATIONAL CANCER INSTITUTE COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP) PRACTICE:Use of the Epic EHR.
  2. NATIONAL CANCER INSTITUTE COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP) PRACTICE: Willingness to incorporate the AH-HA tool in their EHR.
  3. NATIONAL CANCER INSTITUTE COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP) PRACTICE: Have two or more providers willing to be trained and use AH-HA.
  4. NATIONAL CANCER INSTITUTE COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP) PRACTICE: Identified providers saw >= 100 potentially eligible patients (combined total for all providers) for follow-up in prior 6 months.
  5. SURVIVOR: >= 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, or androgen deprivation are allowed.
  6. SURVIVOR: 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.
  7. SURVIVOR: Able and willing to complete a follow-up assessment in one year.
  8. SURVIVOR: Survivors must have no evidence of disease at the time of last medical visit for all cancers, except non-melanoma skin disease.
  9. SURVIVOR: Age >= 18 years.
  10. SURVIVOR: Able to understand and willing to provide verbal informed consent.
  11. KEY INFORMANT: Age 18 >= years.
  12. KEY INFORMANT: Health care provider who completed the AH-HA provider training (e.g., physicians, nurse practitioners, physician assistants) AND two members of the site administrative team who participated in the implementation of the AH-HA tool. This will include clinic administrators and/or information technology specialists and is likely to include: facility program directors and other staff (e.g., technology support). Coordinators of centralized services for EHR maintenance at the practice would also be eligible.
  13. KEY INFORMANT: Agrees to participate in a confidential 1-on-1 semi-structured interview with the research team.
  14. KEY INFORMANT: Agrees to have the interview taped, transcribed and qualitatively analyzed.

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.