Abstract

Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention

Patient Educ Couns. 2022 May;105(5):1075-1081.doi: 10.1016/j.pec.2021.09.030. Epub 2021 Sep 30.

 

Ellen A Lipstein 1William B Brinkman 2Yin Zhang 3Kevin A Hommel 4Richard F Ittenbach 5Chunyan Liu 3Lee A Denson 6

 
     

Author information

1Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, USA. Electronic address: ellen.lipstein@cchmc.org.

2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.

3Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.

4Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.

5Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.

6Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.

Abstract

Objective: We conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD).

Methods: We recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms.

Results: Two out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm.

Conclusions: This pilot trial provides important guidance for developing a larger scale trial of a modified intervention.

Practice implications: Overall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.

 

 

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