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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
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.
- 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.
- 30-day mortality [ Time Frame: 30 days ]Number of deaths within 30 days after discharge, all causes
- 30-day re-admission [ Time Frame: 30 days ]Number of re-admissions to hospital or MAW within 30 days after discharge, all causes
- Length of stay [ Time Frame: 8 days ]Number of days patients are admitted to either hospital or MAW
- Number of inpatients stays [ Time Frame: 3 months ]Number of inpatient stays in a healthcare institution
- Transfer of patients between MAW and hospital [ Time Frame: 1 year ]Number of patients transferred from MAW to hospital
- 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.
- 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.
- 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)].
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885206
|Contact: Ann-Chatrin Leonardsen, PhDfirstname.lastname@example.org|
|Contact: Hilde Lurås, PhDemail@example.com|
|Study Chair:||Stefan Sütterlin, Professor||Ostfold University College|