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
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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 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 trial start date
01/09/2011
Overall trial end date
31/08/2013
Reason abandoned (if study stopped)
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
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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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23234237
2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29362248
Publication citations
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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.
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Results
Schäfer I, Kaduszkiewicz H, Mellert C, Löffler C, Mortsiefer A, Ernst A, Stolzenbach CO, Wiese B, Abholz HH, Scherer M, van den Bussche H, Altiner A. , Narrative medicine-based intervention in primary care to reduce polypharmacy: results from the cluster-randomised controlled trial MultiCare AGENDA, BMJ Open, 2018, doi: 10.1136/bmjopen-2017-017653.