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

NCT06410768 | Enrolling By Invitation

• 1 other identifier: METC2023-0114
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes mellitus; person-centered care; shared decision-making; pilot study; patient decision aid; economic evaluation

Outcome Measures

Primary Outcomes (27)

• 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

  9 months

• Sample retention

  Retention rates: percentage of participants who completed the study

  9 months

• Consent rates

  Consent rates: number of patients enrolled divided by number of eligible patients

  9 months

• Recruit to target

  Time required to recruit to target sample size

  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.

  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.

  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.

  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.

  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)

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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.

  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.

  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.

  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).

  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.

  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.

  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

  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.

  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).

  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).

  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.

  Throughout the 9-month implementation period

Study Arms (2)

Intervention

OTHER

The intervention entails a multistage shared decision-making (SDM) program for type 2 diabetes mellitus (T2DM) that combines (1) an online PDA with (2) a preparatory consult for patients, and (3) interprofessional training in the PDA and SDM for healthcare professionals.

Behavioral: multistage shared decision-making program

Control

NO INTERVENTION

Patients and healthcare professionals in the control practices will provide and receive usual care according to the national guidelines for T2DM of the Dutch College of General Practitioners (NHG). Participants in the control practices will not have access to the multistage SDM program.

Interventions

multistage shared decision-making program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is diagnosed with type 2 diabetes mellitus
• Eighteen years or older
• Need to decide on type 2 diabetes treatment based on the national guidelines
• Multiple treatment options (medication and/or lifestyle) are possible as judged by the healthcare professional
• Speak Dutch at a necessary level to complete questionnaires and ensure involvement in shared decision-making

You may not qualify if:

• Severe cognitive impairments that hamper shared decision-making

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Maastricht University: collaborator

Study Sites (1)

Care group Huisarts & Zorg

Gorinchem, Netherlands

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Arianne Elissen, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 13, 2024
• Study Start: February 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be made publicly available as a research article in a scientific journal. The protocol is under review (April 2024).
• Access Criteria: There will be no access criteria for the protocol (open access publication)

Locations

NL (1)