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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03885206
Other study ID # HS2522-40480
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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