Clinical trial NCT03885206: Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital
Official title: Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Experience
Medical Emergencies
Mortality
Morbidity
Co-morbidity
Quality of Life
Lead sponsor: Ostfold University College
Sponsor class: OTHER
Collaborators: name: Extrastiftelsen, Akersgatab28, No-0158Oslo, Norway
name: The National Association for Heart and Lung Disease, Jessheim, Norway
name: University of Oslo
name: University Hospital, Akershus
name: Ostfold Hospital Trust
First posted: 2019-03-21
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The referring physician in a casualty in the casualty will judge the patients´ eligibility for inclusion, Study nurses in the casualty will invite participants, and receive patients´ written informed consent to participate, and then randomize the patients to either the MAW or the hospital, using a simple randomization procedure with numbered sheets in sealed, opaque envelopes. The patients will then be transported to the MAW or hospital according to the random allocation procedure.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Demographic changes in the industrialized world are expected to prompt a need for better organized and more efficient health care services. In order to curb costs, health care providers in many countries are searching for viable alternatives to hospitalizations. Norwegian white papers and reform documents presume that the municipalities will play a central role in meeting the growth in demand for health services. Central public policy documents and national research strategies highlight that we need pathways characterized by good quality and safe care, and which are responsive to needs, based on user involvement, continuity of care and successful collaboration within and between service levels. The 2012 Coordination Reform placed new responsibilities on municipalities in the delivery of primary health care services and on hospitals as deliverers of specialist services, as well as on the integration and collaboration between the two organizational levels. This reform mandates that all 428 Norwegian municipalities are obliged to establish or co-operate on establishing Municipal Acute Wards (MAW) (In Norwegian: Kommunale akutte døgnplasser), so as to alleviate pressure on hospitals. However, the research basis for these units is relatively weak. Hence, there is little information on the outcomes regarding the quality, cost-effectiveness, patient-reported as well as personnel-reported outcomes of this new level of care.

This study aims at assessing the outcome of admissions to MAWs compared to a general hospital for patients in need of acute care, that can be treated at a lower and decentralized level of health care, with potentially less resources than traditional hospitalizations. The study will use a Randomized Controlled Trial (RCT) design. It builds on previous research and systematic reviews, and aims to assess several outcomes, patient experiences (NORPEQ), health-related quality of life, short-term mortality and morbidity, and draws on linkages to national registers. The primary hypothesis is that there is no difference in patient experiences between admissions to a MAW versus a hospital. The secondary hypothesis was that there is no difference in outcomes such as readmission, length of stay, self-assessed health-related quality of life (HRQoL) measured by the EuroQol 5 items 5 level (EQ-5D-5L) index, and health status measured by the RAND-12, between patients admitted to a MAW versus a hospital

Detailed description: No other randomized, controlled studies have been conducted to compare healthcare services as offered in MAWs to those offered in hospital. The study will use an RCT design, which is a strong study design. The study includes measures of patient experiences and HRQoL. The project is interdisciplinary and cross-sectoral, and it represents research in, about and with support from the municipalities, which is a prioritized area of research, together with health services research, for the owners of the Østfold Hospital Trust, Helse Sør-Øst (HSØ). The project incorporates users in the planning of the project, which may contribute better acceptance of and a successful completion of the project. This proposal addresses key aspects of the CR and other national strategic documents. The CR has mandated the establishment of MAWs all over Norway as of 2016, without any strong scientific documentation of cost-effectiveness. The study builds on data from previous research, stating that there is a need for more solid documentation about new levels of acute hospital care. The proposed study will assess several aspects of quality of care and will contribute useful information for evaluation and future planning of MAWs, as an alternative to hospitalization. Therefore the researchers think this project is timely. The MAWs in Østfold County are small to medium-sized and are expected to be representative for the majority of MAWs in Norway, and therefore of broad national interest. These outputs will be important for authorities, politicians, healthcare leaders, and professionals as well as researchers involved in developing, implementing and refining decentralized acute health care services as an alternative to hospitalization- to the best of the patients. Moreover, the project outputs will be of international interest, in particular in countries with national health insurance with broad coverage, as in the Nordic countries, the UK, Canada and Australia.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Ability to provide written, informed consent
* Eligible for admission at a MAW according to established admission criteria
* Assessed and referred by a GP, by a physician at the local Casualty (Legevaktslege), or a physician in a nursing home on the same day

Exclusion Criteria:

* Psychiatric or cognitive impairment
* No Norwegian national identification number
* Acute disability in elderly, requiring extensive diagnostic procedures
* Patients admitted to the MAW via the diagnostic loop\*
* Previous admission to a MAW during the project period (to prevent patients being included more than once in the project)
* Insufficient Norwegian language skills to respond to the questionnaires

Primary outcomes:
measure: Patient Experiences, NORPEQ
timeFrame: 2-4 weeks after discharge
Secondary outcomes:
measure: 30-day Mortality
timeFrame: 30 days
measure: 30-day Re-admission
timeFrame: 30 days
measure: Length of Stay
timeFrame: 8 days
measure: Number of Inpatients Stays
timeFrame: 3 months
measure: Transfer of Patients Between MAW and Hospital
timeFrame: 1,5 year
measure: Patient Experiences
timeFrame: 4 weeks after discharge
measure: Health Status as Assessed With the RAND-12 Instrument
timeFrame: 4 weeks after discharge
measure: Eq5D5L
timeFrame: 1,5 year
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Ostfold Hospital Trust
state: Østfold
Study officials:
affiliation: Ostfold University College
name: Stefan Sütterlin, Professor
role: STUDY_CHAIR
References: