- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885206
Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital
Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital: a Multicenter, Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Østfold
-
Sarpsborg, Østfold, Norway, 1714
- Ostfold Hospital Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient experiences, NORPEQ
Time Frame: 2-4 weeks after discharge
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day mortality
Time Frame: 30 days
|
Number of deaths within 30 days after discharge, all causes
|
30 days
|
30-day re-admission
Time Frame: 30 days
|
Number of re-admissions to hospital or MAW within 30 days after discharge, all causes
|
30 days
|
Length of stay
Time Frame: 8 days
|
Number of days patients are admitted to either hospital or MAW
|
8 days
|
Number of inpatients stays
Time Frame: 3 months
|
Number of inpatient stays in a healthcare institution
|
3 months
|
Transfer of patients between MAW and hospital
Time Frame: 1,5 year
|
Number of patients transferred from MAW to hospital
|
1,5 year
|
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 |
4 weeks after discharge
|
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.
|
4 weeks after discharge
|
Costs and cost-effectiveness
Time Frame: 1,5 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)]. |
1,5 year
|
Eq5D5L
Time Frame: 1,5 year
|
Health related quality of life. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement |
1,5 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Stefan Sütterlin, Professor, Ostfold University College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS2522-40480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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