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

Ellen A Lipstein, William B Brinkman, Yin Zhang, Kevin A Hommel, Richard F Ittenbach, Chunyan Liu, Lee A Denson

Journal: Patient education and counseling 2022;105(5):1075-1081

PMID: 34629231

Full Text on Elsevier Science View on PubMed

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.

Address: Department 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: [email protected].; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.; Department 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.; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA; Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.

DOI: 10.1016/j.pec.2021.09.030

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MeSH Terms: Child, Decision Making, Decision Making, Shared, Humans, Inflammatory Bowel Diseases, Patient Participation, Pilot Projects, Quality of Life, Tumor Necrosis Factor Inhibitors