Caution ahead

Research challenges of a randomized controlled trial implemented to improve breast cancer treatment at safety-net hospitals

Nina A. Bickell, Ajay Shah, Maria Castaldi, Theophilus Lewis, Alan Sickles, Shalini Arora, Kevin Clarke, Margaret Kemeny, Anitha Srinivasan, Kezhen Fei, Rebeca Franco, Michael K. Parides, Peter Pappas, Ann Scheck McAlearney

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)e158-e167
JournalJournal of Oncology Practice
Volume14
Issue number3
DOIs
StatePublished - Mar 1 2018
Externally publishedYes

Fingerprint

Safety-net Providers
Randomized Controlled Trials
Breast Neoplasms
Research
Therapeutics
High-Volume Hospitals
Random Allocation

ASJC Scopus subject areas

  • Oncology
  • Oncology(nursing)
  • Health Policy

Cite this

Caution ahead : Research challenges of a randomized controlled trial implemented to improve breast cancer treatment at safety-net hospitals. / Bickell, Nina A.; Shah, Ajay; Castaldi, Maria; Lewis, Theophilus; Sickles, Alan; Arora, Shalini; Clarke, Kevin; Kemeny, Margaret; Srinivasan, Anitha; Fei, Kezhen; Franco, Rebeca; Parides, Michael K.; Pappas, Peter; McAlearney, Ann Scheck.

In: Journal of Oncology Practice, Vol. 14, No. 3, 01.03.2018, p. e158-e167.

Research output: Contribution to journalArticle

Bickell, NA, Shah, A, Castaldi, M, Lewis, T, Sickles, A, Arora, S, Clarke, K, Kemeny, M, Srinivasan, A, Fei, K, Franco, R, Parides, MK, Pappas, P & McAlearney, AS 2018, 'Caution ahead: Research challenges of a randomized controlled trial implemented to improve breast cancer treatment at safety-net hospitals', Journal of Oncology Practice, vol. 14, no. 3, pp. e158-e167. https://doi.org/10.1200/JOP.2017.026534
Bickell, Nina A. ; Shah, Ajay ; Castaldi, Maria ; Lewis, Theophilus ; Sickles, Alan ; Arora, Shalini ; Clarke, Kevin ; Kemeny, Margaret ; Srinivasan, Anitha ; Fei, Kezhen ; Franco, Rebeca ; Parides, Michael K. ; Pappas, Peter ; McAlearney, Ann Scheck. / Caution ahead : Research challenges of a randomized controlled trial implemented to improve breast cancer treatment at safety-net hospitals. In: Journal of Oncology Practice. 2018 ; Vol. 14, No. 3. pp. e158-e167.
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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.",
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AU - Lewis, Theophilus

AU - Sickles, Alan

AU - Arora, Shalini

AU - Clarke, Kevin

AU - Kemeny, Margaret

AU - Srinivasan, Anitha

AU - Fei, Kezhen

AU - Franco, Rebeca

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