Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital

NCT ID: NCT03885206

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-01-31

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.

Conditions

Patient Experience; Medical Emergencies; Mortality; Morbidity; Co-morbidity; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Hospital

Level of healthcare service: Patients who can be admitted to a municipal acute ward (MAW) will be admitted to the hospital instead, so that the intervention is that patients are admitted to a higher level facility than needed. Recieve medical treatment as usual.

Group Type: EXPERIMENTAL

Level of healthcare services

Intervention Type: OTHER

Patiens judged to be eligible for admittance to a municipal acute care wrad will be admitted to hospital as an intervnetion, to be able to compare same patient groups.

Municipal acute ward

Patients admitted to decentralized, municipal acute care wards after being assessed by a referring physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Level of healthcare services

Patiens judged to be eligible for admittance to a municipal acute care wrad will be admitted to hospital as an intervnetion, to be able to compare same patient groups.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Extrastiftelsen, Akersgatab28, No-0158Oslo, Norway

OTHER_GOV

Sponsor Role: collaborator

The National Association for Heart and Lung Disease, Jessheim, Norway

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: collaborator

Ostfold University College

OTHER

Sponsor Role: lead

Responsible Party

Ann-Chatrin Leonardsen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Sütterlin, Professor

Role: STUDY_CHAIR

Ostfold University College

Locations

Ostfold Hospital Trust

Sarpsborg, Østfold fylke, Norway

Countries

Norway

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HS2522-40480

Identifier Type: -

Identifier Source: org_study_id