Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic

Study Overview
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Brief Summary
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Aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews.

Detailed Description
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Patients will be randomised to either standard care(annual visit at outpatient clinic) or standard care plus an intervention. The intervention is a medication consultation of 30-60 minutes that consist of a medication review and increased cross-sectoral communication. Follow-up is 6 months. Primary outcome are number of medications used, secondary outcomes are health related quality of life and persistance of medication changes.

Official Title
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Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic

Conditions
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Polypharmacy

Intervention / Treatment
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* Other: Medication review
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DM2 12 medications in the central prescription list Exclusion Criteria: inability to give written consent (e.g., inability to understand the intervention or language barriers); active cancer or palliative treatment; admitted to the hospital.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Standard care + medication review | Other: Medication review<br>* 30-60 minutes extra consultation regarding the patients drugs<br>Other: Standard care<br>* Standard care i.e. visit at the Dept. of Endocrinology.<br>|
| Other: Control<br>Standard care | Other: Standard care<br>* Standard care i.e. visit at the Dept. of Endocrinology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of medications used at baseline compared to number of medications used at follow-up. Resulting in a rate of medications used at baseline compared to follow-up i.e. no. medication at follow-up/no. at baseline. | The no. of medications used at baseline will be compared to the no. of medications used at follow-up. This will result in a rate i.e. no. at follow-up/no. at baseline which can be compared between groups resulting in a rate ratio. Medication usage is determined by number of medications listed in the central prescription list. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ5D index score. (a Euro Quality of Life 5-dimension 5-level (EQ-5D-5L) scale). The score is retrieved by using the validated EQ5D questionnaire which translates to a corresponding EQ5D index score using country specific value sets. | Health related quality of life measured by EQ5D index score using Danish value sets (ranging from -0.7 (worst quality of life) to 1 (best quality of life)). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polypharmacy