Effects of structuring doctor-patient-communication in primary care of patients with multimorbidity (MultiCare AGENDA)

ISRCTN	ISRCTN46272088
DOI	https://doi.org/10.1186/ISRCTN46272088
Protocol serial number	01ET1006A-K
Sponsor	German Federal Ministry of Education and Research (Germany)
Funder	German Federal Ministry of Education and Research (Germany) (Funding no. 01ET1006A-K)

Submission date: 01/09/2011
Registration date: 28/11/2011
Last edited: 05/02/2018

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 Hanna Kaduszkiewicz
Scientific

University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care
Martinistr. 52
Hamburg
20246
Germany

Email	kaduszki@uke.de

Study information

Primary study design	Interventional
Study design	Multi-center parallel group cluster-randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	MultiCare AGENDA
Study objectives	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(s)	Ethics Committee of the Medical Association of Hamburg approved on 1st July 2011, approval no. PV3788
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	600
Key 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)
Key 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
Date of first enrolment	01/09/2011
Date of final enrolment	31/08/2013

Locations

Countries of recruitment

Germany

Study participating centre

University Medical Center Hamburg-Eppendorf

Hamburg
20246
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/01/2018		Yes	No
Protocol article	protocol	12/12/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/02/2018: Publication reference has been added.