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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03426475
Other study ID # 01811
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2018
Est. completion date April 22, 2021

Study information

Verified date July 2022
Source University Medical Center Goettingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


Recruitment information / eligibility

Status Completed
Enrollment 680
Est. completion date April 22, 2021
Est. primary completion date June 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Utilization of Medical Care by Nursing Home Residents

Intervention

Procedure:
interprof ACT measures
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary cumulative number of hospitalisation Cumulative incidence of hospitalisations from nursing home residents within 12 months within 12 months
Secondary absolute number of hospitalisations number of hospitalisations within 12 months within 12 months
Secondary hospital days Hospital days within 12 months within 12 months
Secondary mortality mortality within 12 months within 12 months
Secondary potentially inadequate medications potentially inadequate medications at baseline and for follow-ups at 6 and 12 months baseline and after 6 and 12 months
Secondary Adverse Events Adverse Events within 12 months within 12 months
Secondary 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. baseline and after 12 months
Secondary 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). baseline and after 12 months
Secondary medical services use of other medical services within 12 months within 12 months
Secondary economic evaluation: efficiency economic evaluation: efficiency (incremental cost-effectiveness ratio) and cost savings from payer and societal perspective after 12 months
Secondary Quality of inter-professional collaboration according to the Partnership Self-Assessment Tool (PSAT) score Higher score values indicating better collaboration. after 12 months
Secondary 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. after 12 months