Clinical trial NCT06410768: Economic Evaluation of a Multistage Shared Decision-making Program for Type 2 Diabetes: a Pilot Study
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes mellitus
person-centered care
shared decision-making
pilot study
patient decision aid
economic evaluation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2024-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Severe cognitive impairments that hamper shared decision-making

Primary outcomes:
measure: Sample recruitment
timeFrame: 9 months
measure: Sample retention
timeFrame: 9 months
measure: Consent rates
timeFrame: 9 months
measure: Recruit to target
timeFrame: 9 months
measure: Age (years)
timeFrame: Measured at baseline
measure: Sex (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Country of birth (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Educational level (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Financial (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Work situation (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Duration of type 2 diabetes (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Weight (kg) (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Height (cm) (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Medication use (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Medication adherence measured with the Medication Adherence Report Scale (MARS)
timeFrame: Baseline, 3-months and 9-months follow-up
measure: Health literacy (self-reported questionnaire)
timeFrame: Measured at baseline
measure: Study management measured by conducting focus groups with participating healthcare professionals
timeFrame: Focus groups will be held at the end of patient inclusion period, 9-months
measure: Patient decisional conflict measured with the decisional conflict scale (DCS)
timeFrame: Throughout implementation period, 9-months
measure: Patient-rated level of shared decision-making measured with the 3-item CollaboRATE survey
timeFrame: Throughout implementation period, 9-months
measure: Patient-rated level of shared decision-making measured with the SDM-Q-9 questionnaire
timeFrame: Throughout implementation period, 9-months
measure: Healthcare professional level of shared decision-making measured with the SDM-Q-Doc questionnaire
timeFrame: Throughout implementation period, 9-months
measure: Patient knowledge measured with tailor-made questions
timeFrame: Measured at baseline
measure: Glycemic control obtained from general practitioner data
timeFrame: Baseline, 3-months and 9-months follow-up
measure: Health-related quality of life measured with the EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) questionnaire
timeFrame: Baseline, 3-months and 9-months follow-up
measure: Medical consumption measured with the iMCQ
timeFrame: Baseline, 3-months and 9-months follow-up
measure: Productivity costs measured with the iPCQ
timeFrame: Baseline, 3-months and 9-months follow-up
measure: Understandability of measurement tools
timeFrame: Throughout the 9-month implementation period
Secondary outcomes:
Other outcomes:
Locations:
city: Gorinchem
country: Netherlands
facility: Care group Huisarts & Zorg
Study officials:
affiliation: Maastricht University
name: Arianne Elissen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
citation: ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009.
citation: Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
citation: Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
citation: Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
citation: Stacey D, Suwalska V, Boland L, Lewis KB, Presseau J, Thomson R. Are Patient Decision Aids Used in Clinical Practice after Rigorous Evaluation? A Survey of Trial Authors. Med Decis Making. 2019 Oct;39(7):805-815. doi: 10.1177/0272989X19868193. Epub 2019 Aug 17.
citation: Kellar I, Mann E, Kinmonth AL, Prevost AT, Sutton S, Marteau TM. Can informed choice invitations lead to inequities in intentions to make lifestyle changes among participants in a primary care diabetes screening programme? Evidence from a randomized trial. Public Health. 2011 Sep;125(9):645-52. doi: 10.1016/j.puhe.2011.05.010. Epub 2011 Jul 20.
citation: Branda ME, LeBlanc A, Shah ND, Tiedje K, Ruud K, Van Houten H, Pencille L, Kurland M, Yawn B, Montori VM. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res. 2013 Aug 8;13:301. doi: 10.1186/1472-6963-13-301.
citation: Mathers N, Ng CJ, Campbell MJ, Colwell B, Brown I, Bradley A. Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice. BMJ Open. 2012 Nov 5;2(6):e001469. doi: 10.1136/bmjopen-2012-001469. Print 2012.
citation: Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
citation: Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
citation: van Teijlingen E, Hundley V. The importance of pilot studies. Nurs Stand. 2002 Jun 19-25;16(40):33-6. doi: 10.7748/ns2002.06.16.40.33.c3214.
citation: Black SA. Diabetes, diversity, and disparity: what do we do with the evidence? Am J Public Health. 2002 Apr;92(4):543-8. doi: 10.2105/ajph.92.4.543.
citation: Brodaty H, Gibson LH, Waine ML, Shell AM, Lilian R, Pond CD. Research in general practice: a survey of incentives and disincentives for research participation. Ment Health Fam Med. 2013 Sep;10(3):163-73.
citation: McKinley N, McCain RS, Convie L, Clarke M, Dempster M, Campbell WJ, Kirk SJ. Resilience, burnout and coping mechanisms in UK doctors: a cross-sectional study. BMJ Open. 2020 Jan 27;10(1):e031765. doi: 10.1136/bmjopen-2019-031765.
citation: West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018 Jun;283(6):516-529. doi: 10.1111/joim.12752. Epub 2018 Mar 24.
citation: Tichler A, Hertroijs DFL, Ruwaard D, Brouwers MCGJ, Hiligsmann M, de Jong JD, Elissen AMJ. Preferred Conversation Topics with Respect to Treatment Decisions Among Individuals with Type 2 Diabetes. Patient Prefer Adherence. 2023 Mar 17;17:719-729. doi: 10.2147/PPA.S397647. eCollection 2023.
citation: Legare F, Ratte S, Gravel K, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: update of a systematic review of health professionals' perceptions. Patient Educ Couns. 2008 Dec;73(3):526-35. doi: 10.1016/j.pec.2008.07.018. Epub 2008 Aug 26.