Implementing Medication Reviews Through Interdisciplinary Dialogue in Patients With Coexisting Diabetes and Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Medicinal load
研究概览
简要总结
This study aims to investigate the potential beneficial effects of a medication review by a clinical pharmacologist on patients with coexisting severe mental illness and diabetes. The study is an intervention study in which an intervention group is assigned to the medication review whereas a control group is not. Both groups are tested using an extensive test battery at baseline and 6 months after inclusion.
Furthermore a qualitative data assessment will be undertaken using interviews and/or surveys in order to show any obstacles in implementing the intervention. This is relevant as medication reviews, performed by clinical pharmacologists as well as pharmacists, are not always implemented by the primary physician.
The economic impact of the medication review will furthermore be assessed.
详细描述
The effects of a medication review on patients with coexisting severe mental illness and diabetes:
Introduction:
Severe mental illness (SMI) is associated with an increased risk of diabetes (DM) and metabolic complications. The risk of type-2 diabetes is increased 2-3 fold in patients with SMI compared to the average population. This may lead to polypharmacy hence adverse drug interactions as well as adverse side effects emphasizing the need for a thorough medication review. Medication reviews by pharmacists is widely used and implemented in clinical practice. However, to the investigators knowledge studies on medication reviews by medical doctors specialized in the field of clinical pharmacology let alone on this patient cohort is scarce. Hence, this study seeks to investigate the effects of a medication review by a clinical pharmacologist on patients with coexisting severe mentall illness and diabetes.
Quality control:
The study protocol will be send for approval by the Danish National Committee on Health Research Ethics. Regarding data managing the study is send to Region Zealand's list of ongoing projects thereby ensuring responsible data managing in accordance with the current legislation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients drafted must have diabetes (unspecified) and severe mental illness in this case schizophrenia, severe ADHD, anxiety, any other psychotic disorders or an affective disorder (e.g. bipolar disease and major depression). Patients are drafted from the "fusion clinic" in Slagelse Denmark which is a collaboration between endocrinologists and psychiatrists in the joint treatment of patients with diabetes and mental illness.
- •Only adult patients
排除标准
- •none of the above
- •Pediatric patients
结局指标
主要结局
Medicinal load
时间窗: 6 months
Total amount of drugs prescribed
Adverse side effects
时间窗: 6 months
The number of potentiel drug related side effects
Adverse drug interactions
时间窗: 6 months
Amount of potential drug interactions
次要结局
- UKU side effect rating scale ("UKU" is a danish acronym for the "Task force for clinical investigations")(6 months)
- SF-12 (short form survey)(6 months)
- Hamilton-17(6 months)
- Young manic rating scale (YMRS)(6 months)
- PANSS-6 (positive and negative syndrome scale)(6 months)
- MARS (medication adherence rating scale).(6 months)
- CGI (Clinical Global impression scale)(6 months)
- Biomarkers(6 months)