Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 5, 2024
Open Peer Review Period: Jun 7, 2024 - Jul 6, 2024
Date Accepted: Oct 26, 2024
(closed for review but you can still tweet)
FORAIDMUCO protocol : Pilot implementation of shared decision making in the treatment of diabetes in adult patients with cystic fibrosis: a mixed comparative evaluation of a training program dedicated to cystic fibrosis reference centers
ABSTRACT
Background:
Diabetes affects half of cystic fibrosis (CF) patients aged 30 years and older. It progresses asymptomatically over a long period of time. Two treatment options are possible: start insulin now with the additional constraints of cystic fibrosis or wait while monitoring the patient's clinical condition and start insulin when symptoms develop and therefore later. This situation is particularly well suited to shared decision-making (SDM) between physician (healthcare team) and patient/relatives.
Objective:
To conduct a qualitative analysis of the outcomes and experience of the implementation of SDM between physician/healthcare team and patient/relatives for CF related diabetes.
Methods:
Three CF reference centres (CFRCs) will be trained in SDM using an online training including a validated decision aid and a live coaching for physicians and the medical team. Two control CFRCs will maintain their usual practices. A comparative here and elsewhere multicentric quasi-experimental study comparing the populations of the 2 groups will be realized. A qualitative analysis through observation of consultations, individual semi-structured interviews with patients and focus groups in CFRCs will be conducted. 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 centre), i.e. 60 consultation observations (2 consultations per patient in the intervention groups given the modalities of the SDM process). Eight focus groups will be conducted in the 5 centres (2 groups in each intervention CFRC and one 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 the CFRCs is increased by an implementation strategy and to analyze the experience of patients and caregivers regarding decision-making modalities. Analysis of the outcomes and experience of the implementation of SDM are of importance to identify facilitators and barriers to SDM from patients’ and CFRCs point of views.
Conclusions:
Our study will give us keys to adapt, improve and disseminate more widely SDM. SDM could thus be used in routine clinical practice in CFRCs at the national level. Clinical Trial: NCT04891159 – May 18, 2021
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