Condition category
Signs and Symptoms
Date applied
21/07/2010
Date assigned
31/08/2010
Last edited
31/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.allgemeinmedizin.uni-frankfurt.de/forschung.html

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

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 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 the 7th July 2009 (see http://www.controlled-trials.com/ISRCTN99691973 for details of this pilot project).

Ethics approval

Ethics Committee of Medicine at Johann Wolfgang-Goethe University approved on the 20th May 2010 (ref: E 46/10)

Study design

Pragmatic cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below 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 measures

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

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

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

Patient

Age group

Adult

Gender

Both

Target number of participants

No. GP: 70; No. patients: 490

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

http://www.uni-frankfurt.de/english/index.html

Funders

Funder type

Government

Funder name

Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes