Economic Evaluation of a Multistage Shared Decision-making Program for Type 2 Diabetes: a Pilot Study - Trial NCT06410768

Timeline & Enrollment

Primary Outcome

Sample recruitment,Sample retention,Consent rates,Recruit to target,Age (years),Sex (self-reported questionnaire),Country of birth (self-reported questionnaire),Educational level (self-reported questionnaire),Financial (self-reported questionnaire),Work situation (self-reported questionnaire),Duration of type 2 diabetes (self-reported questionnaire),Weight (kg) (self-reported questionnaire),Height (cm) (self-reported questionnaire),Medication use (self-reported questionnaire),Medication adherence measured with the Medication Adherence Report Scale (MARS),Health literacy (self-reported questionnaire),Study management measured by conducting focus groups with participating healthcare professionals,Patient decisional conflict measured with the decisional conflict scale (DCS),Patient-rated level of shared decision-making measured with the 3-item CollaboRATE survey,Patient-rated level of shared decision-making measured with the SDM-Q-9 questionnaire,Healthcare professional level of shared decision-making measured with the SDM-Q-Doc questionnaire,Patient knowledge measured with tailor-made questions,Glycemic control obtained from general practitioner data,Health-related quality of life measured with the EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) questionnaire,Medical consumption measured with the iMCQ,Productivity costs measured with the iPCQ,Understandability of measurement tools

Summary

Type 2 diabetes mellitus is a highly prevalent disease, affecting over a million Dutch
 citizens, leading to severe micro- and macrovascular complications, reduced quality of life,
 and high healthcare costs. Clinical guidelines recommend a person-centered approach to
 improve (health)outcomes. However, with rapidly increasing treatment options, both in terms
 of medication and lifestyle interventions, shared decision making (SDM) is challenging in
 practice. Therefore, researchers have developed a multistage SDM program consisting of an
 online patient decision aid for type 2 diabetes mellitus, training for healthcare
 professionals in SDM, and a preparatory consult to provide patients with the knowledge and
 confidence to participate in SDM. Strong evidence of (cost)-effectiveness is a key
 requirement to achieve broad implementation of this program. This pilot study represents an
 important initial step towards high-quality economic evaluation research, with a focus on the
 diversity of the study population, burden on participating healthcare practices, and
 feasibility of outcome measurement.

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