Prioritising and Optimising Multi-medication in Multimorbidity

Study Overview
=================
Brief Summary
-----------------
Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices. Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.

Detailed Description
-----------------
Key elements (1 to 4) of the complex intervention: Basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (HCA) and Checklist-based (MediMoL - Medication-Monitoring-List) pre-consultation interview on problems relating to medicines (technical handling, potential adverse drug reactions) and patient's therapeutic aims by HCA provides structured information in the Medication-Monitoring-List (MediMoL) for the general practitioner (GP) and enables patients to discuss their problems with the GP. GP uses a computerized decision support system (pharmaceutical information system, AiD+) to optimize medication (reducing number of inappropriate prescriptions, e.g. pharmaceutical interactions, renal dose adjustments, duplicate prescriptions) and prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.

Official Title
-----------------
Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Other: Optimization strategy (complex intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 60 years old of both sexes at least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment at least five long-term prescriptions with systemic effects health care provided by GP (at least one contact in most recent quarter) patient is legally competent to sign any documents ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews written informed consent to participate in trial Exclusion Criteria: diseases cause life expectancy of less than 12 months abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof cognitive impairment that prevents trial participation (MMSE < 26) emotional stress that prevents trial participation participation in a clinical trial within the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care in accordance with recommended standard# #Recommended standard: clinical practice guideline Geriatrie of the guideline group of Hesse (part 1 and 2) | |
| Experimental: Intervention arm<br>Intervention: Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard# #Recommended standard: clinical practice guideline Geriatrie of the guideline group of Hesse (part 1 and 2) | Other: Optimization strategy (complex intervention)<br>* Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard# #Recommended standard: clinical practice guideline Geriatrie of the guideline group of Hesse (part 1 and 2)<br>* Other names: Intervention arm;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Appropriateness Index (MAI)-Score | Difference in Medication Appropriateness Index (MAI)-Score 6 months from baseline minus baseline (MAI T1-T0) | 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAI-Score | Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0) | 9 months from baseline | 
| Generic health related quality of life: EQ-5D | Change in generic health related quality of life measured as the difference in the EQ-5D-Score 6 months from baseline minus baseline (T1-T0) | 6 months from baseline | 
| Generic health related quality of life: EQ-5D | Change in generic health related quality of life measured as the difference in the EQ-5D-Score 9 months from baseline minus baseline (T2-T0) | 9 months | 
| Functional disability: Vulnerable Elderly Survey (VES-13) | Change in functional disability measured as the difference in the VES-13-Score 6 months from baseline minus baseline (T1-T0) | 6 months | 
| Functional disability: Vulnerable Elderly Survey (VES-13) | Change in functional disability measured as the difference in the VES-13-Score 9 months from baseline minus baseline (T2-T0) | 9 months | 
| Change in all cause hospitalisation |  | 6 months and 9 months | 
| Observed adherence | Change in observed adherence measured as the difference between intake (patient's interview) and prescribed medication (CRF reported by physician's) 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) | 6 months from baseline and 9 months from baseline | 
| Self-reported adherence (Morisky) | Change in self-reported adherence measured as the difference in the Morisky-Score 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) | 6 and 9 months from baseline | 
| Future life expectancy / years of desired life | Change in perceived future life expectancy reflects concepts of will to life or years of desired life [YDL] measured as the difference of the three items future expectation / expected lifetime duration / desired lifetime duration in the interval 6 months | 6 and 9 months from baseline | 
| medication complexity | Change in complexity of medication measured as the difference 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) Total number of prescriptions Number of single doses / day Medication Regimen Complexity Index (MRCI) | 6 and 9 months from baseline | 
| Beliefs about Medicines Questionaire (BMQ) | Change in health and illness beliefs and attitudes measured as the difference in the Beliefs about Medicines Questionaire (BMQ) score 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) | 6 and 9 months from baseline | 
| Severity of chronic pain | Change in severity of chronic pain measured as the difference in Characteristic Pain Intensity score, the Disability Score, in Disability Points and the resulting Grades of chronic pain severity in accordance with M. von Korff, J. Ormel et al. the interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) | 6 and 9 months from baseline | 
| Satisfaction with shared decision making (Man Son Hing scale, MSH) | Change in satisfaction with shared decision making measured as the difference in the Man Son Hing scale (MSH) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) | 6 and 9 months from baseline | 
| Cognitive dysfunction in verbal fluency | Change in cognitive (dys)function measured as the difference in the Verbal Fluency Test (VFT) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) | 6 and 9 months from baseline | 
| Depressive symptoms | Change in depressive symptoms measured as the difference in the Geriatric Depression Scale (GDS) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) | 6 and 9 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, multimorbidity, polypharmacy, multimedication, medication appropriateness, medication appropriateness index, cluster-randomised controlled trial, pragmatic trial