Prioritising and optimising multiple medications in elderly multi-morbid patients in general practice

ISRCTN	ISRCTN99691973
DOI	https://doi.org/10.1186/ISRCTN99691973
Protocol serial number	01GK0702
Sponsor	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Funder	Bundesministerium für Bildung und Forschung (ref: 01GK0702)

Submission date: 18/05/2009
Registration date: 07/07/2009
Last edited: 17/12/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christiane Muth
Scientific

Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
Frankfurt
60590
Germany

Study information

Primary study design	Interventional
Study design	Pilot open-label two-arm cluster-randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Prioritising and optimising multiple medications in elderly multi-morbid patients in general practice: a pilot open-label two-arm cluster-randomised controlled trial
Study acronym	PRIMUM pilot
Study objectives	The aim of this pilot study is to test the feasibility of a complex intervention in the general practice on the appropriateness of medication in elderly multi-morbid patients and the feasibility of a cluster-randomised controlled trial.
Ethics approval(s)	Ethics Committee of Medicine, Johann Wolfgang-Goethe University, Frankfurt, 24/03/2009, ref: 54/09
Health condition(s) or problem(s) studied	Multi-medication in elderly multi-morbid patients
Intervention	The trial has two arms: one intervention arm and one control arm. The intervention consists of several components: 1. Medication reconciliation (brown-bag review) 2. Structured interview lead by practice nurse on problems related to medications based on a checklist (medication monitoring list, MediMoL) 3. Use of a computerised decision support system on medications (AiD+) 4. Counselling session with GP on medication-related problems The total duration of the intervention is three weeks. Practices in the control arm procede as usual (i.e. there is no sham control). The duration of the follow-up period (which starts after the second data collection) is six weeks.
Intervention type	Other
Primary outcome measure(s)	1. To evaluate practicability: expenditure of time regarding intervention 2. To evaluate feasibility: number of patients who dropped out, reasons for why patients do not participate in study, time expenditure regarding data collection 3. Potential primary outcome for main study: appropriateness of medication (Medication Appropriateness Index [MAI]) There are three timepoints of data collection in both, the control and the intervention arm: T0: before the beginning of the intervention T1: six weeks after the beginning of the intervention T2: twelve weeks after the beginning of the intervention
Key secondary outcome measure(s)	1. Complexity of medication (number of drugs, number of daily doses, Medication Regimen Complexity Index [MRCI]) 2. Observed adherence (drug score, dose score, regimen score) 3. Reported adherence (Medication Adherence Report Scale [MARS] and adherence according to Morisky) 4. Patient attitude toward medication (Beliefs about Medicines Questionnaire [BMQ]) 5. Patient satisfaction regarding information about medication 6. Health related quality of life (EQ-5D) 7. Functional disability (World Health Organization Disability Assessment Schedule II [WHO-DASII]) 8. Pain (Verbal Rating Scale) 9. Hospital days 10. Number of medication side effects There are three timepoints of data collection in both, the control and the intervention arm: T0: before the beginning of the intervention T1: six weeks after the beginning of the intervention T2: twelve weeks after the beginning of the intervention
Completion date	03/11/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	100
Key inclusion criteria	Patients: 1. At least 65 years old, either sex 2. At least three chronic diseases 3. At least five continuous prescriptions 4. At least one practice visit during the last quarter 5. Written informed consent 6. Ability to fill out a questionnaire and participate in a telephone interview Practices: 1. Practice serves members of the German statutory health insurance system 2. GP practice 3. Physician is specialised in general practice or internal medicine, or without specialisation 4. Internet access 5. Availability of a practice nurse who can participate in the study
Key exclusion criteria	Patients: 1. Life expectancy of less than six months 2. Drug addiction problems 3. Cognitive impairment (Mini Mental State Examination [MMSE] score less than 26) 4. Emotional stress that would prevent participation in the study 5. Participation in a clinical trial within the last 30 days
Date of first enrolment	13/05/2009
Date of final enrolment	03/11/2009

Locations

Countries of recruitment

Germany

Study participating centre

Johann Wolfgang Goethe University

Frankfurt
60590
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/07/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/12/2018: IPD sharing statement added.
28/07/2016: Publication reference added.