Prioritising and optimising multiple medications in elderly multi-morbid patients in general practice
| ISRCTN | ISRCTN99691973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99691973 |
| Secondary identifying numbers | 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
Scientific
Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
Frankfurt
60590
Germany
Study information
| Study design | Pilot open-label two-arm cluster-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 13/05/2009 |
| Completion date | 03/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
60590
Germany
Sponsor information
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Government
Government
Hannoversche Strasse 28-30
Berlin
10115
Germany
| Website | http://www.bmbf.de |
|---|---|
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Bundesministerium für Bildung und Forschung (ref: 01GK0702)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
Editorial Notes
17/12/2018: IPD sharing statement added.
28/07/2016: Publication reference added.
