Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluating the Feasibility of a Future Trial-based Economic Evaluation of a Multistage Shared Decision-making Program for the Treatment of Type 2 Diabetes Mellitus: a Pilot Study
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.
Rationale: Previous randomized controlled trials researching the effects of shared decision-making (SDM) support through patient decision aids (PDAs) for type 2 diabetes mellitus (T2DM) experienced several challenges related to study procedures, resources, and study management. These challenges include difficulties in recruiting participants, understandability of questionnaires, timely recruitment, and inadvertent recruitment bias. Small-scale piloting is crucial to address uncertainties around the feasibility of trial methods and to refine the study procedures of a large-scale economic evaluation. This protocol outlines a pilot study aimed at evaluating the feasibility of a future trial-based economic evaluation of a multistage SDM program, including a PDA for T2DM in the Netherlands. By conducting a pilot study, the researchers aim to improve the quality of the intended trial-based economic evaluation. Objectives: Researchers will conduct a pilot study focused on the following questions to prepare for an intended economic evaluation of our multistage SDM program for T2DM: 1) How to recruit and retain a representative sample of patients with T2DM in terms of sociodemographic and clinical background?; 2) How to support primary care practices in managing the challenges associated with study participation?; 3) How to feasibly measure relevant outcomes of SDM for T2DM using valid and reliable measurement instruments? Study design: The multistage SDM program will be piloted in a cluster-randomized controlled trial using a mixed-methods approach. Four primary care practices will be included, of which two will be randomly assigned to the intervention group and two to the control group. ;
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