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

NCT03885206 | Completed Results

• 1 other identifier: HS2522-40480
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient Experiences, NORPEQ

  Norwegian Patient Experience Questionnaire. Six of the eight NORPEQ items sum to produce an overall scale from 0 to 100, where 100 is the best possible experience of care. If respondents had missing values on more than half of the items, mean scores will be imputed.

  2-4 weeks after discharge

Secondary Outcomes (8)

• 30-day Mortality

  30 days

• 30-day Re-admission

  30 days

• Length of Stay

  8 days

• Number of Inpatients Stays

  3 months

• Transfer of Patients Between MAW and Hospital

  1,5 year

Study Arms (2)

Hospital

EXPERIMENTAL

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.

Other: Level of healthcare services

Municipal acute ward

NO INTERVENTION

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

Interventions

Level of healthcare services 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.

Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold University College: lead
• Extrastiftelsen, Akersgatab28, No-0158Oslo, Norway: collaborator
• The National Association for Heart and Lung Disease, Jessheim, Norway: collaborator
• University of Oslo: collaborator
• University Hospital, Akershus: collaborator
• Ostfold Hospital Trust: collaborator

Study Sites (1)

Ostfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

Location

Results Point of Contact

• Title: Senior Consultant
• Organization: Landsforeningen for hjerte- og lungesyke

irene.steinsvik@lhl.no

0047 95706313

Study Officials

• Stefan Sütterlin, Professor

  Ostfold University College

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: March 21, 2019
• Study Start: September 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)