Prioritising and Optimising Multi-medication in Multimorbidity (PRIMUM)

Goethe University

Status: Completed

Conditions: Chronic Disease

Treatments: Other: Optimization strategy (complex intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT01171339

1-Muth

Details and patient eligibility

About

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.

Full description

Key elements (1 to 4) of the complex intervention:

1. Basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (HCA) and
2. 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.
3. 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
4. prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.

Enrollment: 505 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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505 participants in 2 patient groups

Control

No Intervention group

Description:

Usual care in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)

Intervention arm

Experimental group

Description:

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)

Treatment:

Other: Optimization strategy (complex intervention)