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

ISRCTN ISRCTN46272088
DOI https://doi.org/10.1186/ISRCTN46272088
Secondary identifying numbers 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

Study designMulti-center parallel group cluster-randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects of structuring doctor-patient-communication in primary care of patients with multimorbidity (MultiCare AGENDA): a multi-center, parallel group, cluster-randomized controlled trial
Study acronymMultiCare AGENDA
Study objectivesWe 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) studiedMultimorbidity
InterventionThe 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/09/2011
Completion date31/08/2013

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsPlanned sample size: 600
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2011
Date of final enrolment31/08/2013

Locations

Countries of recruitment

  • Germany

Study participating centre

University Medical Center Hamburg-Eppendorf
Hamburg
20246
Germany

Sponsor information

German Federal Ministry of Education and Research (Germany)
Government

Hannoversche Straße 28-30
Berlin
10115
Germany

Email information@bmbf.bund.de
ROR logo "ROR" https://ror.org/04pz7b180

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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