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.
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
- Conditions the study is for
- Utilization of Medical Care by Nursing Home Residents
- 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
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 group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Care of nursing home residents as usual. |
| Interventional Group | Experimental | 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. Receives: Procedure: interprof ACT measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative number of hospitalisation
Cumulative incidence of hospitalisations from nursing home residents within 12 months
Measured: within 12 months
Secondary outcomes (11)
absolute number of hospitalisations
number of hospitalisations within 12 months
Measured: within 12 months
hospital days
Hospital days within 12 months
Measured: within 12 months
mortality
mortality within 12 months
Measured: within 12 months
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
Adverse Events
Adverse Events within 12 months
Measured: within 12 months
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
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
medical services
use of other medical services within 12 months
Measured: within 12 months
economic evaluation: efficiency
economic evaluation: efficiency (incremental cost-effectiveness ratio) and cost savings from payer and societal perspective
Measured: after 12 months
Quality of inter-professional collaboration according to the Partnership Self-Assessment Tool (PSAT) score
Higher score values indicating better collaboration.
Measured: after 12 months
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.
- First posted8 Feb 2018
- Study start12 Feb 2018
- Primary completion12 Jun 2020
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Utilization of Medical Care by Nursing Home ResidentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Gavenis, University Medical Center Goettingen
- Investigators
- Eva Hummers, Prof. Dr. med., Principal investigator, Department of General Practice, University Medical Center Goettingen
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 41795085Mazur 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 36934341Steyer 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 35804455Muller 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strategies to Improve General Practitioner-nurse Collaboration and Communication in Regard to Hospital Admissions of Nursing Home Residents.
- ClinicalTrials.gov ID
- NCT03426475
- Acronym / sponsor ID
- interprof ACT / 01811
- Keywords
- nursing home residents, interprofessional collaboration, reduction of hospitalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Care of nursing home residents as usual. |
| Interventional Group | Experimental | Procedure: interprof ACT measuresImplementation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- admission for short term care only
- participation in other projects on interprofessional collaboration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interprof ACT measuresDefinition 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 | Procedure or surgery | Interventional Group |
Primary outcome
cumulative number of hospitalisation
Time frame: within 12 months
Cumulative incidence of hospitalisations from nursing home residents within 12 months
11 secondary outcomes
absolute number of hospitalisations
Time frame: within 12 months
hospital days
Time frame: within 12 months
mortality
Time frame: within 12 months
potentially inadequate medications
Time frame: baseline and after 6 and 12 months
Adverse Events
Time frame: within 12 months
Quality of Life in Alzheimer's Disease scale - Nursing Home version (QoL-AD-NH)
Time frame: 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
medical services
Time frame: within 12 months
economic evaluation: efficiency
Time frame: after 12 months
Quality of inter-professional collaboration according to the Partnership Self-Assessment Tool (PSAT) score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 41795085Luth 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.
- Derived from this study: PubMed 36934341Mazur 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.
- Derived from this study: PubMed 35804455Steyer 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.
- Derived from this study: PubMed 33153484Muller 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Hummers, Prof. Dr. med. principal investigator
Department of General Practice, University Medical Center Goettingen
4 sites in 1 country: see every site and its status.
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.