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

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

      • Göttingen, Germany
        • Department of General Practice, University Medical Center Göttingen
      • Göttingen, Germany
        • Organization and Corporate Development, Georg August University Göttingen
      • Hamburg, Germany
        • Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf
      • Lübeck, Germany
        • Institute for Social Medicine and Epidemiology, Nursing Research Group,University of Lübeck

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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative number of hospitalisation
Time Frame: within 12 months
Cumulative incidence of hospitalisations from nursing home residents within 12 months
within 12 months

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
within 12 months
potentially inadequate medications
Time Frame: baseline and after 6 and 12 months
potentially inadequate medications at baseline and for follow-ups at 6 and 12 months
baseline and after 6 and 12 months
Adverse Events
Time Frame: within 12 months
Adverse Events within 12 months
within 12 months
Quality of Life in Alzheimer's Disease scale - Nursing Home version (QoL-AD-NH)
Time Frame: baseline and after 12 months
Residents' quality of life at baseline and at 12 months. Scale range is 15 - 60, with higher scores indicating higher QoL.
baseline and after 12 months
Health-related Quality of Life (HRQL) of residents measured by EQ-5D-5L
Time Frame: baseline and after 12 months
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).
baseline and after 12 months
medical services
Time Frame: within 12 months
use of other medical services within 12 months
within 12 months
economic evaluation: efficiency
Time Frame: after 12 months
economic evaluation: efficiency (incremental cost-effectiveness ratio) and cost savings from payer and societal perspective
after 12 months
Quality of inter-professional collaboration according to the Partnership Self-Assessment Tool (PSAT) score
Time Frame: after 12 months
Higher score values indicating better collaboration.
after 12 months
Attitudes towards inter-professional collaboration according to the Jefferson Scale of Attitudes Toward Physician-Nurse Collaboration (JSAPNC) score
Time Frame: after 12 months
Higher score values indicating more favourable attitudes.
after 12 months

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.

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

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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