Clinical trial NCT01171339: Prioritising and Optimising Multi-medication in Multimorbidity
Official title: Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: elderly
multimorbidity
polypharmacy
multimedication
medication appropriateness
medication appropriateness index
cluster-randomised controlled trial
pragmatic trial
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Johann Wolfgang Goethe University Hospital
name: University Hospital Heidelberg
name: Heidelberg University
name: Maastricht University Medical Center
name: University of Oxford
First posted: 2010-07-28
Enrollment: 505
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Medication Appropriateness Index (MAI)-Score
timeFrame: 6 months from baseline
Secondary outcomes:
measure: MAI-Score
timeFrame: 9 months from baseline
measure: Generic health related quality of life: EQ-5D
timeFrame: 6 months from baseline
measure: Generic health related quality of life: EQ-5D
timeFrame: 9 months
measure: Functional disability: Vulnerable Elderly Survey (VES-13)
timeFrame: 6 months
measure: Functional disability: Vulnerable Elderly Survey (VES-13)
timeFrame: 9 months
measure: Change in all cause hospitalisation
timeFrame: 6 months and 9 months
measure: "Observed" adherence
timeFrame: 6 months from baseline and 9 months from baseline
measure: Self-reported adherence (Morisky)
timeFrame: 6 and 9 months from baseline
measure: Future life expectancy / years of desired life
timeFrame: 6 and 9 months from baseline
measure: medication complexity
timeFrame: 6 and 9 months from baseline
measure: Beliefs about Medicines Questionaire (BMQ)
timeFrame: 6 and 9 months from baseline
measure: Severity of chronic pain
timeFrame: 6 and 9 months from baseline
measure: Satisfaction with shared decision making (Man Son Hing scale, MSH)
timeFrame: 6 and 9 months from baseline
measure: Cognitive dysfunction in verbal fluency
timeFrame: 6 and 9 months from baseline
measure: Depressive symptoms
timeFrame: 6 and 9 months from baseline
Other outcomes:
Locations:
city: Frankfurt / Main
country: Germany
facility: Institute for General Practice, Goethe-University Frankfurt / Main, Germany
state: Hesse
Study officials:
affiliation: Institute for General Practice, Goethe-University Frankfurt / Main
name: Christiane Muth, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Buedingen F, Hammer MS, Meid AD, Muller WE, Gerlach FM, Muth C. Changes in prescribed medicines in older patients with multimorbidity and polypharmacy in general practice. BMC Fam Pract. 2018 Jul 28;19(1):131. doi: 10.1186/s12875-018-0825-3.
citation: Muth C, Uhlmann L, Haefeli WE, Rochon J, van den Akker M, Perera R, Guthlin C, Beyer M, Oswald F, Valderas JM, Knottnerus JA, Gerlach FM, Harder S. Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial. BMJ Open. 2018 Feb 24;8(2):e017740. doi: 10.1136/bmjopen-2017-017740.