Specialist Conferences Between General Practitioners and Endocrinologists

Diabetes Mellitus, Type 2 Clinical Trial

— STAR  

Official title:

Virtual Specialist Conferences Between General Practitioners and Endocrinologists About Type 2.Diabetes: a Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05268081
• Other study ID #: 1-30-72-353-21
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: June 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Virtual specialist conferences
The intervention consists of four virtual conferences (45 min each in month 2, 5, 8 and 11) and an introductory webinar (90 min in month 1) to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to one specific endocrinologist they meet with throughout. The four virtual conferences are thematic: T2D and cardiovascular disease and heart failure, T2D and lipids, T2D and kidney disease and blood pressure, and T2D and a free topic selected by the GP. At each conference, the GP must bring 2-3 patient cases related to the theme and 1-2 patients of their own choice. The GP chairs the meeting. Each conference follows the same format: Check in (5 min); Short presentation by the endocrinologist (10 min); Presentation by GP and joint dialogue about theme-related patients (20 min); Presentation by GP and joint dialogue about theme-unrelated patients (optional, 5 min); (5) Wrapping-up (5 min).

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Aarhus	Aarhus N	Danmark

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Region MidtJylland Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor	Percentage of patients with type 2-diabetes and ischemic heart disease and/or stroke being treated with glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium glucose cotransporter 2 (SGLT2) inhibitor	Month 12
Primary	Micro/macro-albuminuria treated with ACE-inhibitor or AT2	Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)	Month 12
Primary	LDL>2.5 mmol/L treated with Statins	Percentage of patients with type 2-diabetes and LDL>2.5 mmol/L being treated with Statins	Month 12
Primary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general	Self-reported degree to which the general practitioner is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12
Primary	Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general	Self-reported degree to which the general practitioner is confident in: assessing when it is appropriate to initiate insulin treatment; selecting the appropriate medicine, when patients with diabetes need three-agent antidiabetics; selecting the appropriate medicine, when patients with have co-morbidity; achieving a lower level of Hb1Ac in patients with diabetes; high treatment quality for patients with diabetes; setting treatment targets for patients with diabetes; referring the right patients with diabetes to the department of endocrinology.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12
Primary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure	Self-reported degree to which the general practitioner is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; selecting the most appropriate medication for patients with diabetes and cardiovascular disease; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and heart failure; achieving high treatment quality for patients with diabetes and heart failure.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12
Primary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure	Self-reported degree to which the general practitioner is confident in: managing high blood pressure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and high blood pressure; achieving high treatment quality for patients with diabetes and high blood pressure.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12
Primary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease	Self-reported degree to which the general practitioner is confident in: managing kidney disease in patients with diabetes; managing Estimated Glomerular Filtration Rate (eGFR) in patients with diabetes; managing albuminuria in patients with diabetes; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of lowered eGFR; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of albuminuria; achieving high treatment quality for patients with diabetes and kidney disease.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12
Primary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol	Self-reported degree to which the general practitioner is confident in: managing high cholesterol in patients with diabetes; selecting the most appropriate cholesterol lowering medication for patients with diabetes; achieving a lower level of cholesterol among patients with diabetes and high cholesterol.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12
Secondary	Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor	Percentage of patients with type 2-diabetes and ischemic heart disease and/or stroke being treated with glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium glucose cotransporter 2 (SGLT2) inhibitor	Month 24
Secondary	Micro/macro-albuminuria treated with ACE-inhibitor or AT2	Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)	Month 24
Secondary	LDL>2.5 mmol/L treated with Statins	Percentage of patients with type 2-diabetes and LDL>2.5 mmol/L being treated with Statins	Month 24
Secondary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general at 24 month	Self-reported degree to which the general practitioner is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 24
Secondary	Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general at 24 month	Self-reported degree to which the general practitioner is confident in: assessing when it is appropriate to initiate insulin treatment; selecting the appropriate medicine, when patients with diabetes need three-agent antidiabetics; selecting the appropriate medicine, when patients with have co-morbidity; achieving a lower level of Hb1Ac in patients with diabetes; high treatment quality for patients with diabetes; setting treatment targets for patients with diabetes; referring the right patients with diabetes to the department of endocrinology.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 24
Secondary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 24 month	Self-reported degree to which the general practitioner is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; selecting the most appropriate medication for patients with diabetes and cardiovascular disease; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and heart failure; achieving high treatment quality for patients with diabetes and heart failure.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 24
Secondary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure at 24 month	Self-reported degree to which the general practitioner is confident in: managing high blood pressure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and high blood pressure; achieving high treatment quality for patients with diabetes and high blood pressure.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 24
Secondary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease at 24 month	Self-reported degree to which the general practitioner is confident in: managing kidney disease in patients with diabetes; managing Estimated Glomerular Filtration Rate (eGFR) in patients with diabetes; managing albuminuria in patients with diabetes; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of lowered eGFR; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of albuminuria; achieving high treatment quality for patients with diabetes and kidney disease.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 24
Secondary	Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol at 24 month	Self-reported degree to which the general practitioner is confident in: managing high cholesterol in patients with diabetes; selecting the most appropriate cholesterol lowering medication for patients with diabetes; achieving a lower level of cholesterol among patients with diabetes and high cholesterol.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 24
Secondary	Patients with T2D and HbA1c <58 mmol/L at 12 and 24 months	Percentage of patients with type 2-diabetes and HbA1c <58 mmol/L	Month 12 and Month 24
Secondary	Patients with T2D and HbA1c <53 mmol/L at 12 and 24 months	Percentage of patients with type 2-diabetes and HbA1c <53 mmol/L	Month 12 and Month 24
Secondary	Patients with T2D and blood pressure <140 mmHg at 12 and 24 months	Percentage of patients with type 2-diabetes and blood pressure <140 mmHg	Month 12 and Month 24
Secondary	Patients with T2D and blood pressure <130 mmHg at 12 and 24 months	Percentage of patients with type 2-diabetes and blood pressure <130 mmHg	Month 12 and Month 24
Secondary	Patients with T2D and LDL >2.5 mmol/L at 12 and 24 months	Percentage of patients with type 2-diabetes and low-density lipoprotein >2.5 mmol/L	Month 12 and Month 24
Secondary	Patients with T2D and microalbuminuria and LDL >1.8 mmol/L at 12 and 24 months	Percentage of patients with type 2-diabetes and microalbuminuria and LDL >1.8 mmol/L	Month 12 and Month 24
Secondary	Questionnaire for the assessment of general practitioners' rating of relational coordination in the general practice at 12 and 24 months	Self-reported assessment by the general practitioner about their collaboration with the general practice using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.; Range 1-5, higher score indicates relational coordination.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of general practitioners' rating of relational coordination with the hospital at 12 and 24 months	Self-reported assessment by the general practitioner about their collaboration with the hospital using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.; Range 1-5, higher score indicates relational coordination.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of general practitioners' rating of using virtual conferences at 12 and 24 months	Self-reported assessment by the general practitioner about using virtual conferences measured along the four dimensions of the Technology Acceptance Model: perceived usefulness of virtual conferences; perceived ease-of-use of virtual conferences; attitude to using virtual conferences; behavioural intention as regards using virtual conferences.; Range 1-5 from "completely disagree" to "completely agree", higher score indicates higher user ratings.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' rating of relational coordination in the general practice at 12 and 24 months	Self-reported assessment by the practice staff about their collaboration with the general practice using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.; Range 1-5, higher score indicates higher relational coordination.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' rating of relational coordination with the hospital at 12 and 24 months	Self-reported assessment by the practice staff about their collaboration with the hospital using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.; Range 1-5, higher score indicates higher relational coordination.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' rating of using virtual conferences at 12 and 24 months	Self-reported assessment by the practice staff about using virtual conferences measured along four dimensions of the Technology Acceptance Model: perceived usefulness of virtual conferences; perceived ease-of-use of virtual conferences; attitude to using virtual conferences; behavioural intention as regards using virtual conferences.; Range 1-5 from "completely disagree" to "completely agree", higher score indicates higher user ratings.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes in general at 12 and 24 month	Self-reported degree to which the practice staff is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant; achieving high treatment quality for patients with diabetes.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 12 and 24 month	Self-reported degree to which the practice staff is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; achieving high treatment quality for patients with diabetes and heart failure.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and blood pressure at 12 and 24 months	Self-reported degree to which the practice staff is confident in: managing high blood pressure in patients with diabetes; achieving high treatment quality for patients with diabetes and high blood pressure.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and kidney disease at 12 and 24 months	Self-reported degree to which the practice staff is confident in: managing kidney disease in patients with diabetes; achieving high treatment quality for patients with diabetes and kidney disease.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12 and Month 24
Secondary	Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cholesterol at 12 and 24 month	Self-reported degree to which the practice staff is confident in managing high cholesterol in patients with diabetes.; Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.	Month 12 and Month 24

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