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

Quality of Life Clinical Trial

Official title:

Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital: a Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885206
• Other study ID #: HS2522-40480
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2021
• Source: Ostfold University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Sarpsborg	Østfold

Sponsors (6)

Lead Sponsor	Collaborator
Ostfold University College	Extrastiftelsen, Akersgatab28, No-0158Oslo, Norway, Ostfold Hospital Trust, The National Association for Heart and Lung Disease, Jessheim, Norway, University Hospital, Akershus, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30-day mortality	Number of deaths within 30 days after discharge, all causes	30 days
Secondary	30-day re-admission	Number of re-admissions to hospital or MAW within 30 days after discharge, all causes	30 days
Secondary	Length of stay	Number of days patients are admitted to either hospital or MAW	8 days
Secondary	Number of inpatients stays	Number of inpatient stays in a healthcare institution	3 months
Secondary	Transfer of patients between MAW and hospital	Number of patients transferred from MAW to hospital	1,5 year
Secondary	Patient experiences	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
Secondary	Health status as assessed with the RAND-12 instrument	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
Secondary	Costs and cost-effectiveness	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
Secondary	Eq5D5L	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