Clinical trial NCT05268081: Specialist Conferences Between General Practitioners and Endocrinologists
Official title: Virtual Specialist Conferences Between General Practitioners and Endocrinologists About Type 2.Diabetes: a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Specialist conferences
Virtual conferences
Family physician
Endocrinologist
Type 2-diabetes
Randomized Controlled Trial
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Region MidtJylland Denmark
First posted: 2022-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To support the primary care sector in delivering high-quality Type 2-diabetes (T2D), literature reviews emphasize the need for implementing models of collaboration that in a simple and effective way facilitate clinical dialogue between general practitioners (GPs) and endocrinologists. The overall aim of the project is to study if an intervention consisting of structured cross-sectoral and virtual conferences between GPs and endocrinologists about T2D improves diabetes care and increases diabetes competencies and management in general practice. This aim will be studied in a pragmatic randomized controlled trial design. This potential is yet to be fully tapped because of methodological limitations. Studies have also not yet systematically evaluated virtual conferences in the context of chronic care using a high-quality research design.

Detailed description: The overall aim is to study if cross-sectoral and virtual specialist conferences improves diabetes care and increases diabetes competencies and management in general practice. The expectation is that the intervention will:

at the patient level:

* improve adherence to international recommendations on diabetes medication for patients with Type 2-diabetes (T2D)
* improve the risk profile of patients with T2D with a reduction in glycated haemoglobin, blood pressure and cholesterol

at the general practice level:

- improve the self-reported competence and confidence in management of patients with T2D among general practitioners and practice staff

The intervention consists of four virtual and thematic conferences: (1) T2D and cardiovascular disease and heart failure, (2) T2D and lipids, (3) T2D and kidney disease and blood pressure, and (4) T2D and a free topic selected by the general practitioner (GP). Before having the first virtual conference, an introductory webinar is held to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to an endocrinologist who they meet at all four conferences. The intervention was developed using the Medical Research Framework for developing complex interventions.

All general practices located in the Municipality of Aarhus, Denmark are invited (n = 100). Block randomization is performed at the general practice level, and general practices will be randomized in a 1:1 ratio to either the intervention or the control group.

Eligibility criteria: Inclusion Criteria:

* General practices are eligible for inclusion if licensed and located in the municipality of Aarhus.
* GPs must consent to participate in the intervention and collect the data needed to measure patient and general practice outcomes.
* GPs must agree to bring patient cases to the virtual conferences who are ≥18 years, diagnosed with T2D and who they would like to discuss with the endocrinologist.

Exclusion Criteria:

* None

Primary outcomes:
measure: Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
timeFrame: Month 12
measure: Micro/macro-albuminuria treated with ACE-inhibitor or AT2
timeFrame: Month 12
measure: LDL>2.5 mmol/L treated with Statins
timeFrame: Month 12
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general
timeFrame: Month 12
measure: Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general
timeFrame: Month 12
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure
timeFrame: Month 12
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure
timeFrame: Month 12
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease
timeFrame: Month 12
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol
timeFrame: Month 12
Secondary outcomes:
measure: Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
timeFrame: Month 24
measure: Micro/macro-albuminuria treated with ACE-inhibitor or AT2
timeFrame: Month 24
measure: LDL>2.5 mmol/L treated with Statins
timeFrame: Month 24
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general at 24 month
timeFrame: Month 24
measure: Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general at 24 month
timeFrame: Month 24
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 24 month
timeFrame: Month 24
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure at 24 month
timeFrame: Month 24
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease at 24 month
timeFrame: Month 24
measure: Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol at 24 month
timeFrame: Month 24
measure: Patients with T2D and HbA1c <58 mmol/L at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Patients with T2D and HbA1c <53 mmol/L at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Patients with T2D and blood pressure <140 mmHg at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Patients with T2D and blood pressure <130 mmHg at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Patients with T2D and LDL >2.5 mmol/L at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Patients with T2D and microalbuminuria and LDL >1.8 mmol/L at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of general practitioners' rating of relational coordination in the general practice at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of general practitioners' rating of relational coordination with the hospital at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of general practitioners' rating of using virtual conferences at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' rating of relational coordination in the general practice at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' rating of relational coordination with the hospital at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' rating of using virtual conferences at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes in general at 12 and 24 month
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 12 and 24 month
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and blood pressure at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and kidney disease at 12 and 24 months
timeFrame: Month 12 and Month 24
measure: Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cholesterol at 12 and 24 month
timeFrame: Month 12 and Month 24
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Steno Diabetes Center Aarhus
state: Danmark
Study officials:
affiliation: Aarhus University Hospital
name: Thim Prætorius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Praetorius T, Baymler Lundberg AS, Sondergaard E, Tang Knudsen S, Sandbaek A. The effect of virtual specialist conferences between endocrinologists and general practitioners about type 2 diabetes: study protocol for a pragmatic randomized superiority trial. Trials. 2022 Dec 28;23(1):1059. doi: 10.1186/s13063-022-06961-y.