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
Scientific
University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care
Martinistr. 52
Hamburg
20246
Germany
| kaduszki@uke.de |
Study information
| Study design | Multi-center parallel group cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2011 |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned sample size: 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
20246
Germany
Sponsor information
German Federal Ministry of Education and Research (Germany)
Government
Government
Hannoversche Straße 28-30
Berlin
10115
Germany
| information@bmbf.bund.de | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
