TY - JOUR
T1 - Addressing cancer survivors’ cardiovascular health using the automated heart health assessment (AH-HA) EHR tool
T2 - Initial protocol and modifications to address COVID-19 challenges
AU - Foraker, Randi E.
AU - Davidson, Eleanor C.
AU - Dressler, Emily V.
AU - Wells, Brian J.
AU - Lee, Simon Craddock
AU - Klepin, Heidi D.
AU - Winkfield, Karen M.
AU - Hundley, W. Gregory
AU - Payne, Philip R.O.
AU - Lai, Albert M.
AU - Lesser, Glenn J.
AU - Weaver, Kathryn E.
N1 - Funding Information:
Funding source: The project described is supported by the National Institutes of Health and National Cancer Institute (Grant Award Number 1R01CA226078-01 and 2UG1CA189824 Wake Forest NCORP Research Base. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
Randomization and blinding. The unit of randomization is the oncology practice, or ?group?. Group-level randomization accommodates the system-level EHR intervention and minimizes the potential for crossover if enrolled survivors saw multiple providers within a practice. The obvious nature of the clinical decision support tool and the need to work closely with sites to implement the tool in the EHR precludes blinding of survivors, clinicians, and researchers.Ethics and consent. This study is approved by the NCI Central Institutional Review Board (IRB) [22] and the Wake Forest Health Sciences IRB. Each participating institution grants authority to the CIRB to serve as the IRB of record for NCORP studies, in accordance with the NIH's single IRB policy [23]. As described below in the section outlining COVID-19-related modifications, the original in-person consent process was amended in June of 2020 to include remote consent options. The first participant was enrolled in the study in October of 2020.The AH-HA clinical decision support tool. Our team developed and deployed a novel, easy-to-use, EHR-embedded CVH assessment tool, based on the American Heart Association's (AHA) Life's Simple 7 [21]. The tool renders a visual, interactive display of CVH risk factors, automatically populated from the EHR [14?16], alongside a tab that indicates the receipt of cancer treatments (yes or no) with cardiotoxic potential. The tool was designed to be relevant to a diverse population of cancer survivors, including those who did and did not received potentially cardiotoxic treatments, and was developed and refined using input from oncology providers and survivors [17]. The tool does not dictate how oncologists should care for their patients, nor is the AH-HA tool intended to replace primary care management of CV risk factors, intensive behavioral interventions to address weight loss or tobacco use, or specialty management of survivors at high risk for cardiotoxicity. Instead, it is expected to facilitate CVH awareness and action by cancer survivors and their oncology providers, enhance referrals, and promote care coordination. Technology implementation principles followed during our previous study are employed for the current study as well [14]. Oncology providers (physicians, nurse practitioners, or physician assistants) will view two 30-min AH-HA tool tutorials online. The educational sessions will review primary prevention of CV disease risk factors according to AHA guidelines for healthcare professionals, cardiotoxicity of cancer treatments, and case-based examples illustrating use of the AH-HA tool in CVH discussions during survivorship care (see Fig. 2 for a visual of the AH-HA tool). The pre-recorded webinar-style provider training sessions provide case-based examples highlighting how cardiotoxic cancer treatment information can be used as contextual information regarding CV disease risk.Funding source: The project described is supported by the National Institutes of Health and National Cancer Institute (Grant Award Number 1R01CA226078-01 and 2UG1CA189824 Wake Forest NCORP Research Base. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2021 The Authors
PY - 2021/6
Y1 - 2021/6
N2 - Background: The purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach to cancer care delivery research. This study aims to assess the effect of a clinical decision support tool for cancer survivors on cardiovascular health (CVH) discussions, referrals, completed visits with primary care providers and cardiologists, and control of modifiable CVH factors and behaviors. The COVID-19 pandemic has caused widespread disruption to clinical trial accrual and operations. Studies conducted with potentially vulnerable populations, including cancer survivors, must shift towards virtual consent, data collection, and study visits to reduce risk for participants and study staff. Studies examining cancer care delivery innovations may also need to accommodate the increased use of virtual visits. Methods/design: This group-randomized, mixed methods study will recruit 600 cancer survivors from 12 National Cancer Institute Community Oncology Research Program (NCORP) practices. Survivors at intervention sites will use the AH-HA tool with their oncology provider; survivors at usual care sites will complete routine survivorship visits. Outcomes will be measured immediately after the study visit, with follow-up at 6 and 12 months. The study was amended during the COVID-19 pandemic to allow for virtual consent, data collection, and intervention options, with the goal of minimizing participant-staff in-person contact and accommodating virtual survivorship visits. Conclusions: Changes to the study protocol and procedures allow important cancer care delivery research to continue safely during the COVID-19 pandemic and give sites and survivors flexibility to conduct study activities in-person or remotely.
AB - Background: The purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach to cancer care delivery research. This study aims to assess the effect of a clinical decision support tool for cancer survivors on cardiovascular health (CVH) discussions, referrals, completed visits with primary care providers and cardiologists, and control of modifiable CVH factors and behaviors. The COVID-19 pandemic has caused widespread disruption to clinical trial accrual and operations. Studies conducted with potentially vulnerable populations, including cancer survivors, must shift towards virtual consent, data collection, and study visits to reduce risk for participants and study staff. Studies examining cancer care delivery innovations may also need to accommodate the increased use of virtual visits. Methods/design: This group-randomized, mixed methods study will recruit 600 cancer survivors from 12 National Cancer Institute Community Oncology Research Program (NCORP) practices. Survivors at intervention sites will use the AH-HA tool with their oncology provider; survivors at usual care sites will complete routine survivorship visits. Outcomes will be measured immediately after the study visit, with follow-up at 6 and 12 months. The study was amended during the COVID-19 pandemic to allow for virtual consent, data collection, and intervention options, with the goal of minimizing participant-staff in-person contact and accommodating virtual survivorship visits. Conclusions: Changes to the study protocol and procedures allow important cancer care delivery research to continue safely during the COVID-19 pandemic and give sites and survivors flexibility to conduct study activities in-person or remotely.
KW - Breast cancer
KW - Cancer survivors
KW - Cardiovascular diseases
KW - Clinical decision support
KW - Electronic health records
KW - Usability testing
UR - http://www.scopus.com/inward/record.url?scp=85108121596&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2021.100808
DO - 10.1016/j.conctc.2021.100808
M3 - Article
C2 - 34189339
AN - SCOPUS:85108121596
SN - 2451-8654
VL - 22
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100808
ER -