Condition category
Not Applicable
Date applied
01/09/2011
Date assigned
28/11/2011
Last edited
18/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hanna Kaduszkiewicz

ORCID ID

Contact details

University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care
Martinistr. 52
Hamburg
20246
Germany
kaduszki@uke.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01ET1006A-K

Study information

Scientific title

Effects of structuring doctor-patient-communication in primary care of patients with multimorbidity (MultiCare AGENDA): a multi-center, parallel group, cluster-randomized controlled trial

Acronym

MultiCare AGENDA

Study hypothesis

We assume that the number of pharmaceutical agents taken by the patient can be reduced in the intervention group. We will compare the change in medication intake between baseline and follow-up in the intervention and control group. We expect that the mean difference between the changes in both groups will be at least 1.5 drugs less in the intervention group. A minimum difference of 0.5 drugs between both groups is defined as clinically relevant.

In order to include a measure that reflects the subjectivity of the patient we will also measure the health related quality of life. It is assumed that a reduction of medications used will not impair quality of life. We will compare the change in health related quality of life as measured by EuroQoL EQ-5D, UK value set between baseline and follow-up in the intervention and control group. We expect that the mean change in the intervention group will not be statistically significantly inferior to the mean change in the control group.

Ethics approval

Ethics Committee of the Medical Association of Hamburg approved on 1st July 2011, approval no. PV3788

Study design

Multi-center parallel group cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multimorbidity

Intervention

The intervention consists of three special consultations by GPs for patients with multimorbidity.

The consultations comprise of:
1. Performing a narrative doctor-patient-dialogue aimed at carving out treatment targets and priorities of the patient
2. Performing a narrative patient-centred medication review, and
3. Performing a narrative doctor-patient-dialogue reflecting the attainment of treatment targets and priorities of the patient. Before the GPs in the intervention arm start with the respective consultations they will be trained by members of the study team.

Control arm: Care as usual

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number of pharmaceutical agents taken by the patient
2. Health related quality of life as measured by the EuroQoL EQ-5D, UK value set
Measured at baseline and post intervention (12 months)

Secondary outcome measures

1. GPs knowledge of the medication taken by patient
2. Patient satisfaction with GP services as measured by the EUROPEP questionnaire
3. Patient empowerment as measured by the Health Care Empowerment Questionnaire
4. Health care utilization (e.g. contacts with GP and specialists, hospital admissions)
Measured at baseline and post intervention (12 months)

Overall trial start date

01/09/2011

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 65 – 85 years at time of recruitment
2. At least one contact with the GP within the most recent quarter (3 months period)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 600

Participant exclusion criteria

1. Poorly known patients to the general practitioner (GP) because of accidental consultation
2. Patients that are treated by the GP for less than 12 months
3. Patients with less than 3 diagnoses out of a list of 42 groups of chronic diseases and syndromes
4. Insufficient ability to consent (e.g. dementia)
5. Insufficient ability to participate in studies (e.g. severe psychic illness)
6. Severe illness probably fatal within 3 months according to the GP
7. Residence in a nursing home
8. Deafness
9. Insufficient ability to speak and read German
10. Participation in other scientific trials

Recruitment start date

01/09/2011

Recruitment end date

31/08/2013

Locations

Countries of recruitment

Germany

Trial participating centre

University Medical Center Hamburg-Eppendorf
Hamburg
20246
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (Germany)

Sponsor details

Hannoversche Straße 28-30
Berlin
10115
Germany
information@bmbf.bund.de

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Germany) (Funding no. 01ET1006A-K)

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

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23234237

Publication citations

  1. Protocol

    Altiner A, Schäfer I, Mellert C, Löffler C, Mortsiefer A, Ernst A, Stolzenbach CO, Wiese B, Scherer M, van den Bussche H, Kaduszkiewicz H, Activating GENeral practitioners dialogue with patients on their Agenda (MultiCare AGENDA) study protocol for a cluster randomized controlled trial., BMC Fam Pract, 2012, 13, 118, doi: 10.1186/1471-2296-13-118.

Additional files

Editorial Notes