Caution Ahead: Research Challenges of a Randomized Controlled Trial Implemented to Improve Breast Cancer Treatment at Safety-Net Hospitals

J Oncol Pract. 2018 Mar;14(3):e158-e167. doi: 10.1200/JOP.2017.026534. Epub 2018 Jan 3.

Abstract

Purpose: To implement and test a Web-based tracking and feedback (T&F) tool to close referral loops and reduce adjuvant breast cancer treatment underuse in safety-net hospitals (SNHs).

Patient and methods: We randomly assigned 10 SNHs, identified patients with new stage 1 to stage 3 breast cancer, assessed their connection with the oncologist, and relayed this information to surgeons for follow-up. We interviewed key informants about the tool's usefulness. We conducted intention-to-treat and pre- and poststudy analyses to assess the T&F tool and implementation effectiveness, respectively.

Results: Between the study start and intervention implementation, several hospitals reorganized care delivery and 49% of patients scheduled to undergo breast cancer surgery were ineligible because they already were in contact with an oncologist. One high-volume hospital closed. Despite randomization of hospitals, intervention (INT) hospitals had fewer white patients (5% v 16%; P = .0005), and more underuse (28% v 15%; P = .002) compared with usual care (UC) hospitals. Over time, INT hospitals with poorer follow-up significantly reduced underuse compared with UC hospitals (INT hospitals, from 33% to 9%, P = .001 v UC hospitals, from 15% to 11%, P = .5). There was no difference in underuse (9% at INT hospitals, 11% at UC hospitals; P = .8). Hospitals with better follow-up (odds ratio, 0.85; 95% CI, 0.73 to 0.98) had less underuse. In settings with poor follow-up and tracking approaches, key informants found the tool useful. The rapidly changing delivery landscape posed significant challenges to this implementation research.

Conclusion: A T&F tool did not significantly reduce adjuvant underuse but may help reduce underuse in SNHs with poor follow-up capabilities. Inability to discern T&F effectiveness is likely due to encountered challenges that inform lessons for future implementation research.

Trial registration: ClinicalTrials.gov NCT01544374.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Breast Neoplasms / diagnosis
  • Breast Neoplasms / epidemiology*
  • Breast Neoplasms / therapy
  • Female
  • Hospitals*
  • Humans
  • Intention to Treat Analysis
  • Medical Informatics Applications
  • New York City
  • Quality Improvement*
  • Randomized Controlled Trials as Topic*
  • Safety-net Providers* / methods
  • Safety-net Providers* / standards
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01544374