- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03426475
Effect of Strategies to Improve General Practitioner-nurse Collaboration and Communication (interprof ACT)
July 13, 2022 updated by: Karsten Gavenis, University Medical Center Goettingen
Effects of Strategies to Improve General Practitioner-nurse Collaboration and Communication in Regard to Hospital Admissions of Nursing Home Residents.
Previously,six measures were developed for a better collaboration of general practitioners and nurses in nursing homes in a qualitative multistep bottom-up process.
These measures, summarised as the interprof ACT intervention, shall improve the flow of information and the communication between the involved parties and lead to more transparency and effectiveness regarding treatment decisions of nursing home residents.The major aim of this trial is to examine the clinical effectiveness of interprof ACT.
The main hypothesis is that implementation of interprof ACT reduces the cumulative incidence of hospitalisations of nursing home residents within 12 months from 50% to 35% (15% absolute reduction).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
680
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Göttingen, Germany
- Department of General Practice, University Medical Center Göttingen
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Göttingen, Germany
- Organization and Corporate Development, Georg August University Göttingen
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Hamburg, Germany
- Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf
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Lübeck, Germany
- Institute for Social Medicine and Epidemiology, Nursing Research Group,University of Lübeck
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria Residents:
- at least one GP visit in recent three months or
- two GP visits in recent 6 months or
- admission to the nursing home during the precedent 6 months independently of documented GP contacts
- at least 18 years of age
- written informed consent by the resident or her/his legal guardian
Inclusion Criteria Nursing Homes:
- minimum size of 40 residents
- written consent provided by the nursing home Manager Prior to randomisation
Exclusion Criteria Residents:
- admission for short term care only
Exclusion Criteria Nursing Homes:
- participation in other projects on interprofessional collaboration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Care of nursing home residents as usual.
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Experimental: Interventional Group
Implementation of interprof ACT measures to improve collaboration and communication between general practitioners and nursing staff.
Measures are selected and adapted by nursing home management / nurses, GPs and residents' relatives or representatives.
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Definition of common goals between general practitioner and nursing staff, appointment of a contact person, support in assigning medication, use of name badges worn by GPs and nurses during visits, mandatory availability of contact person, standardized procedures for GPs home visits
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cumulative number of hospitalisation
Time Frame: within 12 months
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Cumulative incidence of hospitalisations from nursing home residents within 12 months
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within 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
absolute number of hospitalisations
Time Frame: within 12 months
|
number of hospitalisations within 12 months
|
within 12 months
|
hospital days
Time Frame: within 12 months
|
Hospital days within 12 months
|
within 12 months
|
mortality
Time Frame: within 12 months
|
mortality within 12 months
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within 12 months
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potentially inadequate medications
Time Frame: baseline and after 6 and 12 months
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potentially inadequate medications at baseline and for follow-ups at 6 and 12 months
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baseline and after 6 and 12 months
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Adverse Events
Time Frame: within 12 months
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Adverse Events within 12 months
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within 12 months
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Quality of Life in Alzheimer's Disease scale - Nursing Home version (QoL-AD-NH)
Time Frame: baseline and after 12 months
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Residents' quality of life at baseline and at 12 months.
Scale range is 15 - 60, with higher scores indicating higher QoL.
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baseline and after 12 months
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Health-related Quality of Life (HRQL) of residents measured by EQ-5D-5L
Time Frame: baseline and after 12 months
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The EQ-5D-5L consist of two self-rating components: the EQ-5D descriptive system and a visual analogue scale (EQ VAS).
The EQ-5D descriptive system measures HRQL on the five dimensions "mobility", "self-care", "usual activities", "pain / discomfort" and "anxiety / depression".
On each dimension participants can rate either "no problems" (0), "slight problems" (1), "moderate problems" (2), "severe problems" (3) or "extreme problems" (4), resulting in a score ranging from 0 (best) to 4 (worst).
The scores of the single dimensions can be combined to a sum score ranging from 0 (best) to 20 (worst).
In addition, so called "utility weights" can be attached to any possible combination of answers on the EQ-5D descriptive system which results in a utility score ranging from 0 (death) to 1 (full HRQL), which is then used to calculate quality-adjusted life years (QALYs).
The EQ VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
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baseline and after 12 months
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medical services
Time Frame: within 12 months
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use of other medical services within 12 months
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within 12 months
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economic evaluation: efficiency
Time Frame: after 12 months
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economic evaluation: efficiency (incremental cost-effectiveness ratio) and cost savings from payer and societal perspective
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after 12 months
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Quality of inter-professional collaboration according to the Partnership Self-Assessment Tool (PSAT) score
Time Frame: after 12 months
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Higher score values indicating better collaboration.
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after 12 months
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Attitudes towards inter-professional collaboration according to the Jefferson Scale of Attitudes Toward Physician-Nurse Collaboration (JSAPNC) score
Time Frame: after 12 months
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Higher score values indicating more favourable attitudes.
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after 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eva Hummers, Prof. Dr. med., Department of General Practice, University Medical Center Goettingen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Steyer L, Kortkamp C, Muller C, Tetzlaff B, Fleischmann N, Weber CE, Scherer M, Kuhn A, Jarchow AM, Luth F, Kopke S, Friede T, Konig HH, Hummers E, Maurer I, Balzer K. Implementation, mechanisms of change and contextual factors of a complex intervention to improve interprofessional collaboration and the quality of medical care for nursing home residents: study protocol of the process evaluation of the interprof ACT intervention package. Trials. 2022 Jul 8;23(1):561. doi: 10.1186/s13063-022-06476-6.
- Muller C, Hesjedal-Streller B, Fleischmann N, Tetzlaff B, Mallon T, Scherer M, Kopke S, Balzer K, Gartner L, Maurer I, Friede T, Konig HH, Hummers E. Effects of strategies to improve general practitioner-nurse collaboration and communication in regard to hospital admissions of nursing home residents (interprof ACT): study protocol for a cluster randomised controlled trial. Trials. 2020 Nov 5;21(1):913. doi: 10.1186/s13063-020-04736-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2018
Primary Completion (Actual)
June 12, 2020
Study Completion (Actual)
April 22, 2021
Study Registration Dates
First Submitted
December 5, 2017
First Submitted That Met QC Criteria
February 7, 2018
First Posted (Actual)
February 8, 2018
Study Record Updates
Last Update Posted (Actual)
July 14, 2022
Last Update Submitted That Met QC Criteria
July 13, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 01811
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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