Virtual Specialist Conferences Between General Practitioners and Endocrinologists About Type 2.Diabetes: a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking description of intervention status, i.e., outcomes assessor will not know who received the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
时间窗: Month 12
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
LDL>2.5 mmol/L treated with Statins
时间窗: Month 12
Percentage of patients with type 2-diabetes and LDL\>2.5 mmol/L being treated with Statins
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure
时间窗: Month 12
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.
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease
时间窗: Month 12
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.
Micro/macro-albuminuria treated with ACE-inhibitor or AT2
时间窗: Month 12
Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general
时间窗: Month 12
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.
Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general
时间窗: Month 12
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.
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol
时间窗: Month 12
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.
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure
时间窗: Month 12
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.
次要结局
- Patients with T2D and LDL >2.5 mmol/L at 12 and 24 months(Month 12 and Month 24)
- Patients with T2D and HbA1c <53 mmol/L at 12 and 24 months(Month 12 and Month 24)
- Patients with T2D and blood pressure <140 mmHg at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 24 month(Month 24)
- Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general at 24 month(Month 24)
- Patients with T2D and HbA1c <58 mmol/L at 12 and 24 months(Month 12 and Month 24)
- Patients with T2D and blood pressure <130 mmHg at 12 and 24 months(Month 12 and Month 24)
- Micro/macro-albuminuria treated with ACE-inhibitor or AT2(Month 24)
- Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol at 24 month(Month 24)
- Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor(Month 24)
- LDL>2.5 mmol/L treated with Statins(Month 24)
- Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general at 24 month(Month 24)
- Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure at 24 month(Month 24)
- Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease at 24 month(Month 24)
- Patients with T2D and microalbuminuria and LDL >1.8 mmol/L at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of general practitioners' rating of relational coordination in the general practice at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of general practitioners' rating of using virtual conferences at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cholesterol at 12 and 24 month(Month 12 and Month 24)
- Questionnaire for the assessment of general practitioners' rating of relational coordination with the hospital at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes in general at 12 and 24 month(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and kidney disease at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' rating of relational coordination in the general practice at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' rating of relational coordination with the hospital at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 12 and 24 month(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and blood pressure at 12 and 24 months(Month 12 and Month 24)
- Questionnaire for the assessment of practice staffs' rating of using virtual conferences at 12 and 24 months(Month 12 and Month 24)