Wake Forest University School of Medicine, Winston-Salem, NC
Kathryn E. Weaver , Emily Van Meter Dressler , Heidi D. Klepin , Simon Craddock Lee , Sydney Smith , Brian J Wells , W. Gregory Hundley , Glenn Jay Lesser , Chandylen L Nightingale , Alyssa Throckmorton , Marcia Hernandez , Jenny Marie Hanna , Ian T. Lackey , Kevin Heard , Randi E Foraker
Background: Practice guidelines recommend cardiovascular risk assessment and counseling for cancer survivors. The Automated Heart-Health Assessment study (AH-HA: WF-1804CD, NCT# 03935282) evaluated a novel electronic health record (EHR) clinical decision support tool based on American Heart Association Simple 7 cardiovascular health (CVH) factors to promote provider-patient CVH discussions in outpatient oncology. Methods: This clinic-randomized trial (R01CA226078), coordinated by the Wake Forest NCORP Research Base (UG1CA189824), randomized NCORP oncology practices using the Epic EHR to the AH-HA tool or usual care and enrolled survivors receiving routine care at least 6 months post-curative cancer treatment. The tool rendered an interactive display of risk factors, automatically populated from the EHR, alongside a tab indicating receipt of cancer treatments with cardiotoxic potential. Survivors at AH-HA sites had tool access during a routine visit; survivors at usual care sites did not. Immediately post-visit, each survivor was asked about counseling on 7 CVH factors [body mass index, physical activity, diet, smoking status, blood pressure, cholesterol, and glucose]. The primary endpoint is survivor-reported discussion of non-ideal or missing CVH factors; with 8 randomized practices (ICC=0.03), the study design had 82% power to detect a difference of 20% reported discussions in usual care versus 40% in AH-HA. Additional clinical endpoints were documentation of CVH discussions, referrals to primary care and cardiology, and change in CVH factors over 12 months (ongoing). A mixed effects logistic regression model assessed the effect of AH-HA on CVH discussions between the arms, with study arm as a fixed effect and practice as a random effect. Results: 5 usual care and 4 AH-HA practices enrolled 645 survivors from 10/1/2020- 2/28/2023. The majority had breast cancer (82%; 8% endometrial, 5% colorectal, 5% prostate, lymphoma or multiple types). Most survivors were female (96%; 84% White/non-Hispanic, 8% Black; 3% Hispanic; mean age= 62 yrs and median time since diagnosis=3.6 yrs). 18 participants (3%) did not complete necessary assessments, leaving 627 evaluable. 87% of providers (n=15) rated the tool utility and ease of use positively. Conclusions: The AH-HA tool was acceptable and effective at promoting CVH discussions during routine follow-up care for survivors and referrals to primary care. Clinical trial information: NCT03935282.
Model Estimate (95% CI) | AH-HA Tool (n=291, 4 practices) | Usual Care (n=336, 5 practices) | p-value |
---|---|---|---|
Proportion of survivors reporting ≥1 non-ideal or missing CVH factor discussed | 97.6% (95.6, 98.7) | 54.8% (44.8, 64.4) | <0.001 |
# non-ideal or missing factors discussed | 4.06 (3.46, 4.66) | 1.26 (0.72, 1.81) | <0.001 |
# of factors documented as discussed in EHR | 3.83 (1.82, 5.84) | 0.78 (-1.02, 2.58) | 0.03 |
Reported referral to primary care | 38.6% (33.2, 444) | 25.0% (16.8, 35.5) | 0.03 |
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