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Utilization of Medical Care by Nursing Home Residentsinterprof ACTNCT03426475

Effect of Strategies to Improve General Practitioner-nurse Collaboration and Communication

A study testing interprof ACT measures in people with Utilization of Medical Care by Nursing Home Residents, run by University Medical Center Goettingen at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
interprof ACT measures
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
680 participants
Where
4 sitesGermany
Study dates
12 Feb 2018to 22 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • minimum size of 40 residents
  • written consent provided by the nursing home Manager Prior to randomisation

Who cannot join

  • admission for short term care only
  • participation in other projects on interprofessional collaboration.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites
  • Department of General Practice, University Medical Center Göttingen

    Göttingen

  • Organization and Corporate Development, Georg August University Göttingen

    Göttingen

  • Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf

    Hamburg

  • Institute for Social Medicine and Epidemiology, Nursing Research Group,University of Lübeck

    Lübeck

Other trials in Germany

About this study

Official title: 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).

Being tested
interprof ACT measures
Keywords
nursing home residents, interprofessional collaboration, reduction of hospitalisation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interprof ACT measuresProcedure or surgery

    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

Study groups in NCT03426475
Study groupRoleWhat they receive
Control GroupNo interventionCare of nursing home residents as usual.
Interventional GroupExperimentalImplementation 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.
Receives: Procedure: interprof ACT measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cumulative number of hospitalisation

    Cumulative incidence of hospitalisations from nursing home residents within 12 months

    Measured: within 12 months

Secondary outcomes (11)
  1. absolute number of hospitalisations

    number of hospitalisations within 12 months

    Measured: within 12 months

  2. hospital days

    Hospital days within 12 months

    Measured: within 12 months

  3. mortality

    mortality within 12 months

    Measured: within 12 months

  4. potentially inadequate medications

    potentially inadequate medications at baseline and for follow-ups at 6 and 12 months

    Measured: baseline and after 6 and 12 months

  5. Adverse Events

    Adverse Events within 12 months

    Measured: within 12 months

  6. Quality of Life in Alzheimer's Disease scale - Nursing Home version (QoL-AD-NH)

    Residents' quality of life at baseline and at 12 months. Scale range is 15 - 60, with higher scores indicating higher QoL.

    Measured: baseline and after 12 months

  7. Health-related Quality of Life (HRQL) of residents measured by EQ-5D-5L

    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).

    Measured: baseline and after 12 months

  8. medical services

    use of other medical services within 12 months

    Measured: within 12 months

  9. economic evaluation: efficiency

    economic evaluation: efficiency (incremental cost-effectiveness ratio) and cost savings from payer and societal perspective

    Measured: after 12 months

  10. Quality of inter-professional collaboration according to the Partnership Self-Assessment Tool (PSAT) score

    Higher score values indicating better collaboration.

    Measured: after 12 months

  11. Attitudes towards inter-professional collaboration according to the Jefferson Scale of Attitudes Toward Physician-Nurse Collaboration (JSAPNC) score

    Higher score values indicating more favourable attitudes.

    Measured: after 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start12 Feb 2018
  3. Primary completion12 Jun 2020
  4. Study completion22 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426475
Sponsor's protocol ID
01811
Acronym
interprof ACT
Status last verified
Jul 2022
First submitted
5 Dec 2017
Last updated
14 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luth F, Weber CE, Kortkamp C, Steyer L, Muller CA, Tetzlaff B, Mazur AL, Kuhn A, Scherer M, Kopke S, Friede T, Hummers E, Maurer I, Balzer K. Implementation of a complex intervention to improve interprofessional collaboration in long-term care: results of the mixed-methods process evaluation within the interprof ACT trial. BMC Health Serv Res. 2026 Mar 7;26(1):484. doi: 10.1186/s12913-026-14270-2.

    PubMed 41795085
  • Mazur A, Tetzlaff B, Mallon T, Hesjedal-Streller B, Wei V, Scherer M, Kopke S, Balzer K, Steyer L, Friede T, Pfeiffer S, Hummers E, Muller C. Cluster randomised trial of a complex interprofessional intervention (interprof ACT) to reduce hospital admission of nursing home residents. Age Ageing. 2023 Mar 1;52(3):afad022. doi: 10.1093/ageing/afad022.

    PubMed 36934341
  • 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.

    PubMed 35804455
  • 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.

    PubMed 33153484

Questions about this trial

What is this clinical trial studying?

A study testing interprof ACT measures in people with Utilization of Medical Care by Nursing Home Residents, run by University Medical Center Goettingen at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cumulative number of hospitalisation (time frame: within 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426475, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.

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