Prioritising and optimising multi-medication in multimorbidity

ISRCTN	ISRCTN99526053
DOI	https://doi.org/10.1186/ISRCTN99526053
ClinicalTrials.gov number	NCT01171339
Secondary identifying numbers	01GK0702

Submission date: 21/07/2010
Registration date: 31/08/2010
Last edited: 19/09/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Christiane Muth
Scientific

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

Email	muth@allgemeinmedizin.uni-frankfurt.de

Study information

Study design	Pragmatic cluster-randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet (German only)
Scientific title	Prioritising and optimising multiple medications in elderly multi-morbid patients in general practice: a pragmatic cluster-randomised controlled trial
Study acronym	PRIMUM
Study objectives	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(s)	Ethics Committee of Medicine at Johann Wolfgang-Goethe University, 20/05/2010, ref: E 46/10
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2010
Completion date	29/02/2012

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	No. GP: 70; No. patients: 490
Total final enrolment	502
Key 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
Key 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])
Date of first enrolment	01/08/2010
Date of final enrolment	29/02/2012

Locations

Countries of recruitment

Germany

Study participating centre

Institute for General Practice

Frankfurt / Main
D-60590
Germany

Sponsor information

Johann Wolfgang Goethe University (Germany)
University/education

Theodor-Stern-Kai 7
Frankfurt / Main
D-60590
Germany

Email	Ricarda.Wessinhage@kgu.de
Website	http://www.uni-frankfurt.de/english/index.html
"ROR"	https://ror.org/04cvxnb49

Funders

Funder type

Government

Bundesministerium für Bildung und Forschung
Government organisation / National government

Alternative name(s): Federal Ministry of Education and Research, BMBF
Location: Germany

Results and Publications

Intention to publish date	01/06/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in an open access peer reviewed journal.
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	24/02/2018		Yes	No
Results article	results	28/07/2018		Yes	No

Editorial Notes

19/09/2019: The following changes were made:
1. The ClinicalTrials.gov number was added.
2. The total final enrolment added.
17/12/2018: IPD sharing statement added.
12/12/2018: Publication references added.
02/11/2017: The secondary outcome measures have been updated. The participant level data sharing plan and the publication and dissemination plans have been added.