Mixed Comparative Evaluation of a Training Program Dedicated to Cystic Fibrosis Reference Centers: Protocol for the Pilot Implementation of Shared Decision-Making in the Treatment of Diabetes in Adult Patients With Cystic Fibrosis.

BACKGROUND

Diabetes affects half of the patients with cystic fibrosis who are aged 30 years and older. Diabetes progresses asymptomatically over a long period of time. Two treatment options are possible: start insulin as soon as cystic fibrosis diagnosis is made with the additional constraints of cystic fibrosis or wait while monitoring the patient's clinical condition and start insulin when diabetes symptoms develop and therefore later. This situation is particularly well suited to shared decision-making (SDM) between the physician (health care team) and patient/relatives.

OBJECTIVE

The aim of this study was to perform qualitative and quantitative analyses for evaluating the outcomes and experience of SDM implementation between the physician/health care team trained for SDM and patients/their relatives for cystic fibrosis-related diabetes.

METHODS

A quasi-experimental with a comparison study will be developed. Three cystic fibrosis reference centers (CFRCs) will be trained in SDM by using a web-based training, including a validated decision aid and coaching for physicians and the medical team. Two control CFRCs will maintain their usual practices. A qualitative analysis through observation of consultations, individual semistructured interviews with patients, and focus groups in CFRCs will be conducted based on a thematic content analysis. Questionnaires related to decision-making and experience of decision-making with and without SDM implementation will be administered to patients and physicians.

RESULTS

Forty patients will be included (8 patients in each center), that is, 60 consultation observations (2 consultations per patient in the intervention groups given the modalities of the SDM process) will be conducted in 2025. Eight focus groups will be conducted in the 5 centers (2 groups in each intervention CFRC and 1 group in each control CFRC). This qualitative corpus plus responses to the patient and physician questionnaires will make it possible to know whether the practice of SDM in CFRCs is increased by an implementation strategy and to analyze the experience of patients and their relatives regarding decision-making modalities. Analysis of the outcomes and experience of the implementation of SDM are of importance to identify the facilitators and barriers to SDM from patients' and CFRCs' point of views.

CONCLUSIONS

Our study will give us keys to adapt, improve, and disseminate SDM more widely in the context of cystic fibrosis therapy. SDM could thus be used in routine clinical practice in CFRCs at the national level.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04891159; https://clinicaltrials.gov/study/NCT04891159?id=NCT04891159.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/62931.