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

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ClinicalTrials.gov Identifier: NCT03885206
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
Extrastiftelsen, Akersgatab28, No-0158Oslo, Norway
The National Association for Heart and Lung Disease, Jessheim, Norway
University of Oslo
University Hospital, Akershus
Ostfold Hospital Trust
Information provided by (Responsible Party):
Ann-Chatrin Leonardsen, Ostfold University College

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, including health-related quality of life (HRQoL), patient experiences, cost-effectiveness, short-term mortality and morbidity, and draws on linkages to national registers.


Condition or disease Intervention/treatment Phase
Quality of Life Medical Emergencies Mortality Morbidity Costs Co-morbidity Other: Level of healthcare services Not Applicable

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 undertake an economic evaluation and study other outcomes of an intervention, using an RCT design, which is a strong study design. The study also includes measures of HRQoL and patient experiences. 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 the effectiveness, cost-effectiveness and 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The referring physician in the casualty will judge the patients´ eligibility for inclusion, Study nurses 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital: a Multicenter, Randomized Controlled Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.

No Intervention: Municipal acute ward
Patients admitted to decentralized, municipal acute care wards after being assessed by a referring physician.



Primary Outcome Measures :
  1. Health related quality of life: EQ-5D [ Time Frame: 4 weeks ]

    The primary outcome of the study will be change in HRQoL from inclusion to 4 weeks, as assessed with the EQ-5D Index utility measure.This questionnaire can be self-reported, administered by an interviewer, or by telephone.

    The EQ5D3L consist of the EQ5D descriptive system that measures health-related quality of life in five dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and the EQ visual analogue scale (EQ VAS). Responses are scored according to three levels: 0=no problems, 1=some problems and 3=severe problems. The score can be used as a descriptive system or as an overall EQ-5D-3L index score by assigning weights to each level of each dimension according to the Europe VAS value set. The higher the score, the lesser self- perceived health related quality of life.



Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
    Number of deaths within 30 days after discharge, all causes

  2. 30-day re-admission [ Time Frame: 30 days ]
    Number of re-admissions to hospital or MAW within 30 days after discharge, all causes

  3. Length of stay [ Time Frame: 8 days ]
    Number of days patients are admitted to either hospital or MAW

  4. Number of inpatients stays [ Time Frame: 3 months ]
    Number of inpatient stays in a healthcare institution

  5. Transfer of patients between MAW and hospital [ Time Frame: 1 year ]
    Number of patients transferred from MAW to hospital

  6. Patient experiences [ Time Frame: 4 weeks after discharge ]

    As measured by the NORPEQ questionnaire. The questionnaire consist of eight items. The overall scale goes from 0 to 100, where 100 is the best possible experience of care.

    The


  7. Health status as assessed with the RAND-12 instrument [ Time Frame: 4 weeks after discharge ]
    The RAND-12 health status inventory (aka SF-12) is a commonly used health status instrument, which was developed as part of the Medical outcomes study in the 1980s. It uses 12 items from the SF-36 and can be aggregated to a physical health component score and an mental health component score.

  8. Costs and cost-effectiveness [ Time Frame: 1 year ]

    Costs will be estimated for the patients' hospital stays as

    [Actual inpatient-days*(DRG cost/National average LOS for the DRG)],

    and for each admission to a MAW as

    [Actual inpatient-days*Total annual MAW cost/Total number of MAW inpatient-days)].




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885206


Contacts
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Contact: Ann-Chatrin Leonardsen, PhD +4741668797 ann.c.leonardsen@hiof.no
Contact: Hilde Lurås, PhD hilde.luras@ahus.no

Locations
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Norway
Ostfold Hospital Trust Recruiting
Sarpsborg, Østfold, Norway, 1714
Contact: Ann-Chatrin Leonardsen, PhD    004741668797    annnod@so-hf.no   
Contact: Neazr Raouf, MD    0069860000    nezar.raouf@so-hf.no   
Sponsors and Collaborators
Ostfold University College
Extrastiftelsen, Akersgatab28, No-0158Oslo, Norway
The National Association for Heart and Lung Disease, Jessheim, Norway
University of Oslo
University Hospital, Akershus
Ostfold Hospital Trust
Investigators
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Study Chair: Stefan Sütterlin, Professor Ostfold University College
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Responsible Party: Ann-Chatrin Leonardsen, Associate Professor, Ostfold University College
ClinicalTrials.gov Identifier: NCT03885206    
Other Study ID Numbers: HS2522-40480
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes