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| [ Print-friendly version ] |
| Effects of structuring doctor-patient-communication in primary care of patients with multimorbidity (MultiCare AGENDA) |
| ISRCTN | ISRCTN46272088 |
| ClinicalTrials.gov identifier | |
| Public title | Effects of structuring doctor-patient-communication in primary care of patients with multimorbidity (MultiCare AGENDA) |
| 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 |
| Serial number at source | 01ET1006A-K |
| 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. |
| Lay summary | Not provided at time of registration |
| 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 |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Multimorbidity |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/09/2011 |
| Anticipated end date | 31/08/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned sample size: 600 |
| Interventions |
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 |
| 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) |
| 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) |
| Sources of funding | German Federal Ministry of Education and Research (Germany) (Funding no. 01ET1006A-K) |
| Trial website | |
| Publications | |
| Contact name | Dr Hanna Kaduszkiewicz |
| Address |
University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care Martinistr. 52 |
| City/town | Hamburg |
| Zip/Postcode | 20246 |
| Country | Germany |
| kaduszki@uke.de | |
| Sponsor | German Federal Ministry of Education and Research (Germany) |
| Address |
Hannoversche Straße 28-30
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| City/town | Berlin |
| Zip/Postcode | 10115 |
| Country | Germany |
| information@bmbf.bund.de | |
| Date applied | 01/09/2011 |
| Last edited | 28/11/2011 |
| Date ISRCTN assigned | 28/11/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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