Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Christiane Muth
ORCID ID
Contact details
Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
Frankfurt / Main
D-60590
Germany
-
muth@allgemeinmedizin.uni-frankfurt.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
NCT01171339
Protocol/serial number
01GK0702
Study information
Scientific title
Prioritising and optimising multiple medications in elderly multi-morbid patients in general practice: a pragmatic cluster-randomised controlled trial
Acronym
PRIMUM
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. The study objective will be statistically formulated as a test of the null hypothesis H0: µ1 = µ2 (the mean difference MAI T1 - T0 is equal in the two groups) against the alternative hypothesis H1: µ1 ≠ µ2 (the mean MAI T1 - T0 are different in the two groups). The null hypothesis will be tested at the two-sided significance level of α=0.05.
Because of the cluster randomisation, the primary efficacy analysis will use a multilevel regression approach with patients at level one and practices at level two. The primary analysis will be performed adhering to the intention-to-treat principle. An additional sensitivity analysis will be conducted on a per-protocol analysis set.
Please note that the pilot study to this trial was registered with an ISRCTN on 07/07/2009 (see https://www.isrctn.com/ISRCTN99691973 for details of this pilot project).
Ethics approval
Ethics Committee of Medicine at Johann Wolfgang-Goethe University, 20/05/2010, ref: E 46/10
Study design
Pragmatic cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet (German only)
Condition
Multi-morbidity
Intervention
The trial has two arms: one intervention and one control arm.
In the control arm patients are treated as usual in accordance with the recommended standard.
In the intervention arm patients are treated with a single application of the following complex intervention and as usual based on the recommended standard. The intervention consists of several components which have been shown to be feasible in the pilot study (ISRCTN99691973):
1. Medication reconciliation (brown-bag review)
2. Structured interview lead by health care assistant (HCA) on problems related to medications based on a checklist (Medication Monitoring List [MediMoL])
3. Use of a computerised decision support system on medications ('ArzneimittelinformationsDienst' [AiD+])
4. GP-patient consultation on medication-related problems
All of the components of the complex intervention will be applied one time to each of the patients in the intervention arm. The total duration of the complex intervention per patient is about one week. The total duration of the follow-up in both arms is nine months. The recommended standard in both arms is the clinical practice guideline 'Geriatrie' of the guideline group of Hesse (part 1 and 2).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Difference in Medication Appropriateness Index (MAI) score 6 months from baseline minus baseline (MAI T1 - T0).
There are three timepoints of data collection in both, the intervention and the control arm:
T0: baseline, before randomisation and before beginning of the intervention
T1: six months after baseline
T2: nine months after baseline
Data are collected via practice documentation (case report forms), patient questionnaire, and patient interview.
Secondary outcome measures
Current secondary outcome measures as of 02/11/2017:
MAI T2 - T0 and the difference in the following scores 6 and 9 months from baseline minus baseline (T1 - T0 and T2 - T0):
1. Complexity of medication: Medication Regimen Complexity Index (MRCI), no. of prescriptions / single doses
2. Observed adherence: drug score, dose score, regimen score
3. Reported adherence: adherence according to Morisky
4. Patient attitude toward medication: Beliefs about Medicines Questionnaire (BMQ)
5. Generic health related quality of life (EQ-5D)
6. Functional disability: Vulnerably Elderly Survey 13 items (VES-13)
7. Pain assessment: grade of severity of chronic pain
8. All cause hospitalisation: hospital days
9. Satisfaction with shared decision making: Man-Sin-Hong scale (MSH)
10. Patient's future expectation, expected/desired lifetime duration: Years of Desired Life (YDL)
11. Cognitive dysfunction: Verbal Fluency Test (VFT)
12. Depression: Geriatric Depression Scale (GDS)
There are three timepoints of data collection in both, the intervention and the control arm:
T0: baseline, before randomisation and before beginning of the intervention
T1: six months after baseline
T2: nine months after baseline
Data are collected via practice documentation (case report forms), patient questionnaire, and patient interview.
Previous secondary outcome measures:
MAI T2 - T0 and the difference in the following scores 6 and 9 months from baseline minus baseline (T1 - T0 and T2 - T0):
1. Complexity of medication: Medication Regimen Complexity Index (MRCI)
2. Observed adherence: drug score, dose score, regimen score
3. Reported adherence: adherence according to Morisky
4. Patient attitude toward medication: Beliefs about Medicines Questionnaire (BMQ)
5. Patient satisfaction regarding information about medication
6. Generic health related quality of life (EQ-5D)
7. Functional disability: Vulnerably Elderly Survey 13 items (VES-13)
8. Pain assessment: grade of severity of chronic pain
9. All cause hospitalisation: hospital days
10. Satisfaction with shared decision making: Man-Sin-Hong scale (MSH)
11. Patient's future expectation, expected/desired lifetime duration: Years of Desired Life (YDL)
12. Cognitive dysfunction: Verbal Fluency Test (VFT)
13. Depression: Geriatric Depression Scale (GDS)
There are three timepoints of data collection in both, the intervention and the control arm:
T0: baseline, before randomisation and before beginning of the intervention
T1: six months after baseline
T2: nine months after baseline
Data are collected via practice documentation (case report forms), patient questionnaire, and patient interview.
Overall trial start date
01/08/2010
Overall trial end date
29/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients:
1. At least 60 years old of both sexes
2. At least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment
3. At least five long-term prescriptions with systemic effects
4. Health care provided by GP (at least one contact in most recent quarter)
5. Patient is legally competent to sign any documents
6. Ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews
7. Written informed consent to participate in trial
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 doctor with no specialist field
4. Internet access
5. Investigator's agreement to fulfil the contractual obligations arising from the trial
6. Investigator's agreement to the training of a health care assistant (HCA) from the practice for the intervention, as required by the trial
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
No. GP: 70; No. patients: 490
Total final enrolment
502
Participant exclusion criteria
Patients:
1. Diseases cause life expectancy of less than 12 months
2. Abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof
3. Cognitive impairment that prevents trial participation (mini-mental state examination [MMSE] less than 26)
4. Emotional stress that prevents trial participation
5. Participation in a clinical trial within the last 30 days
Practices:
1. Practice focuses on unconventional medical treatments
2. Practice focuses on special indications (e.g. human immunodeficiency virus [HIV])
Recruitment start date
01/08/2010
Recruitment end date
29/02/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Institute for General Practice
Frankfurt / Main
D-60590
Germany
Sponsor information
Organisation
Johann Wolfgang Goethe University (Germany)
Sponsor details
Theodor-Stern-Kai 7
Frankfurt / Main
D-60590
Germany
-
Ricarda.Wessinhage@kgu.de
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung
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
Planned publication in an open access peer reviewed journal.
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
01/06/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29478012
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30055583