Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01GK0702
Study information
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
Acronym
PRIMUM pilot
Study hypothesis
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
Ethics Committee of Medicine, Johann Wolfgang-Goethe University, Frankfurt, 24/03/2009, ref: 54/09
Study design
Pilot open-label two-arm cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
13/05/2009
Overall trial end date
03/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
13/05/2009
Recruitment end date
03/11/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Johann Wolfgang Goethe University
Frankfurt
60590
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Sponsor details
Hannoversche Strasse 28-30
Berlin
10115
Germany
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung (ref: 01GK0702)
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27456328