An observational study in Diabetes and Cystic Fibrosis, sponsored by Hospices Civils de Lyon. Status unknown at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Hospices Civils de Lyon · Observational
Diabetes affects half of cystic fibrosis patients aged 30 years and older. It develops asymptomatically for a long time. Also, two options are possible: start insulin treatment now with the additional constraints associated with cystic fibrosis or wait while monitoring the patient's clinical status and initiate insulin treatment when he has developed symptoms and therefore later. In practice, the choice between these two options takes place over two medical consultations without a formalized shared decision-making process between the doctor and the patient.
Shared decision-making is a decision-making process in which the healthcare provider and the patient learn about patients care options and then deliberate to reach a common agreement on the decision taken.
Shared decision-making seemed particularly relevant to us in cystic fibrosis where there are complex treatment options with variable short-, medium- and long-term side effects and where the disease and its treatments have a high impact on the patient's quality of life.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's planned enrollment of 40 is below the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Major cystic fibrosis patients
Concerning the patient :
Concerning the health professionals :
Medical and paramedical professionals practising in the adult Cystic Fibrosis Centers Competences (doctors, nurses, dieticians, psychologists, physiotherapists, etc...)
Exclusion Criteria:
During the first consultation (V1), the doctor will present the patient on the therapeutic treatment information related to diabetes according to the shared decision making (options, benefits, risks) with the assistance of decision support tools. The decision-making visit will take place after a reflection period of 8 to 15 days after V1. A discussion based on the feedback from this period of reflection will take place between the two actors and either there is a common agreement on the decision taken (shared decision-making), or the decision is taken by the patient, or the decision is made by the physician at the request of the patient. A social sciences and humanities methodologist will attend each consultation, onsite or in videoconferencing. After the consultation, he realized a semi-structured interview with the patient. During this interview, the patient filled the self-administered questionnaires: SDM-Q-9, SURE, CollaboRATE, Spielberger test and the research team questionnaire
Other: Shared decision making
Decision-making for insulin therapy is based on the usual practice defined in each Cystic Fibrosis Centers Competences with decision-making procedures specific to each center and doctor. The decision-making process is generally carried out in two consultations. A social sciences and humanities methodologist will attend each consultation, onsite or in videoconferencing. After the consultation, he realized a semi-structured interview with the patient. During this interview, the patient filled the self-administered questionnaires (SDM-Q-9, SURE, CollaboRATE, Spielberger test and the research team questionnaire).
The intervention consists of 5 components: 1) Online shared decision making training (2 hours, e-learning); 2) Individual coaching for doctors by a shared decision making expert; 3) Implementation of the shared decision making; 4) Link to institutional approaches to patient engagement; 5) Integration of the shared decision making into the multidisciplinary consultation meetings of the Cystic Fibrosis Centers Competences.
Adoption of a shared decision making measured by the total score obtained on the 9 items of the shared decision making questionnaire (SDM-Q-9), translated into French.
The SDM-Q-9 is a self-administered questionnaire of 9 items coded on a 6-point Likert scale. A total score between 0 and 45 is calculated from the sum of the scores obtained for the 9 questions. This score is converted between 0 and 100 by multiplying by a factor of 20/9, 0 indicating a non adoption of shared decision making as perceived by the patient and conversely 100 indicating an adoption of shared decision making as perceived by the patient. The total score will be described in each group by mean, standard deviation, median, quartiles and extent, and will be compared between the 2 groups with a non-parametric Wilcoxon test.
Time frame: The principal endpoint is measured for interventional group : immediately after the second consultation, for control group : immediately after the consultation where the treatment decision is taken (consultation 1 or 2)
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon