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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
40
The multistage shared decision-making program consists of 1) an online patient decision aid; 2) preparatory consult to provide patients with the knowledge and confidence to participate in shared decision-making; and 3) training to improve healthcare professionals' skills for shared decision-making.
Care group Huisarts & Zorg
Gorinchem, Netherlands
Sample recruitment
Recruitment rates: how many patients were recruited on average for one month at one location. Time required to recruit to the target Sociodemographic and clinical characteristics
Time frame: 9 months
Sample retention
Retention rates: percentage of participants who completed the study
Time frame: 9 months
Consent rates
Consent rates: number of patients enrolled divided by number of eligible patients
Time frame: 9 months
Recruit to target
Time required to recruit to target sample size
Time frame: 9 months
Age (years)
Age of participating patients in years. Patients are asked to complete a questionnaire at baseline that includes a question regarding their age.
Time frame: Measured at baseline
Sex (self-reported questionnaire)
Sex of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their sex.
Time frame: Measured at baseline
Country of birth (self-reported questionnaire)
Country of birth of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their country of birth.
Time frame: Measured at baseline
Educational level (self-reported questionnaire)
Educational level of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their highest received diploma.
Time frame: Measured at baseline
Financial (self-reported questionnaire)
Make ends meet financially of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their financial situation (i.e. whether they have (not) difficulties in making ends meet financially)
Time frame: Measured at baseline
Work situation (self-reported questionnaire)
Work situation of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their work situation.
Time frame: Measured at baseline
Duration of type 2 diabetes (self-reported questionnaire)
Duration of diabetes of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding how many years they have type 2 diabetes.
Time frame: Measured at baseline
Weight (kg) (self-reported questionnaire)
Weight of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding what their weight in kg is. This measure is used, in combination with height, to calculate their BMI.
Time frame: Measured at baseline
Height (cm) (self-reported questionnaire)
Height of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding what their height in cm is. This measure is used, in combination with weight, to calculate their BMI.
Time frame: Measured at baseline
Medication use (self-reported questionnaire)
Medication use of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding whether they use medication, and if so, whether they take oral medication or inject insulin.
Time frame: Measured at baseline
Medication adherence measured with the Medication Adherence Report Scale (MARS)
Medication adherence measured with the Medication Adherence Report Scale (MARS) test. This test contains six statements regarding medication adherence and patients are asked to indicate whether the statements applies to them on a five point Likert Scale. Patients are asked to complete this test at baseline, 3 months and 9 months follow-up.
Time frame: Baseline, 3-months and 9-months follow-up
Health literacy (self-reported questionnaire)
Health literacy of participating patients measured with the shortened version of the European Health Literacy Survey questionnaire (HLS-EU) Dutch questionnaire (6 questions)
Time frame: Measured at baseline
Study management measured by conducting focus groups with participating healthcare professionals
Assessment of primary care practices' study management challenges (i.e. time constraints and capacity issues). This will be assessed by conducting focus groups with healthcare professionals from the participating general practices.
Time frame: Focus groups will be held at the end of patient inclusion period, 9-months
Patient decisional conflict measured with the decisional conflict scale (DCS)
Decisional conflict measured with the 16-item decisional conflict scale (DCS). Patients will be asked to reflect on the treatment decision they made with their healthcare professional and respond to 16 statements in the DCS using a five-point Likert scale (ranging from completely agree to completely disagree). Besides a total score, the DCS includes five dimensions (i.e. information, support, clarification or values, certainty, and decision quality) with higher scores on a five-point scale indicating more decisional conflict. Patients are asked to complete this questionnaire at baseline, 3 months and 9 months follow-up.
Time frame: Throughout implementation period, 9-months
Patient-rated level of shared decision-making measured with the 3-item CollaboRATE survey
Patient-rated level of shared decision-making is measured by the 3-item CollaboRATE survey. The CollaboRATE survey assesses patients' perception of being informed and engaged in the decision-making steps on a scale of zero (no effort was made) to nine (every effort was made). Patients are asked to complete this questionnaire at baseline, 3 months and 9 months follow-up.
Time frame: Throughout implementation period, 9-months
Patient-rated level of shared decision-making measured with the SDM-Q-9 questionnaire
Patient-rated level of shared decision-making is measured by the SDM-Q-9 questionnaire. The SDM-Q-9 questionnaire measures the extent of shared decision-making durin a consultation between the patient and healthcare professional. This questionnaire consists of nine statements each describing a different step of the shared decision-making process. All items are scored on a six-point Likert scale from zero (completely disagree) to five (completely agree).
Time frame: Throughout implementation period, 9-months
Healthcare professional level of shared decision-making measured with the SDM-Q-Doc questionnaire
The SDM Q-Doc questionnaire (SDM-Q-9 adapted to the healthcare professional viewpoint) is used to measure the level of shared decision-making during a consultation from the perspective of a healthcare professional.
Time frame: Throughout implementation period, 9-months
Patient knowledge measured with tailor-made questions
Patient knowledge is measured with nine tailor-made multiple-choice questions assessing patients' understanding of the (risks and benefits of) glucose-lowering treatments.
Time frame: Measured at baseline
Glycemic control obtained from general practitioner data
Glycemic control of participating patients will be obtained by obtaining HbA1c data from the general practitioner
Time frame: Baseline, 3-months and 9-months follow-up
Health-related quality of life measured with the EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) questionnaire
Health-related quality of life of participating patients will be measured with the Dutch EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) This measure facilitates utility calculations and includes the EQ-5D dimension and the EQ visual analog scale (EQ VAS). EQ-5D comprises five dimensions: mobility, self-care, pain, usual activities and anxiety. Each dimension is scored on a five-point Likert score (from no problems to extreme problems). The EQ VAS is used to assess the patient's self-reported health on a visual analog scale.
Time frame: Baseline, 3-months and 9-months follow-up
Medical consumption measured with the iMCQ
Medical consumption will be measured with an adapted version of the institute for Medical technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ).
Time frame: Baseline, 3-months and 9-months follow-up
Productivity costs measured with the iPCQ
Productivity costs will be measured with an adapted version of the institute for Medical technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ).
Time frame: Baseline, 3-months and 9-months follow-up
Understandability of measurement tools
Sem-structured interviews with patients will be held to gain insight into the understandability of the measurement tools.
Time frame: Throughout the 9-month implementation period
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