Patient ExperienceNCT03885206
Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital
A study testing Level of healthcare services in people with Patient Experience and Medical Emergencies, run by Ostfold University College at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Experience, Medical Emergencies, Mortality
- What is being tested?
- Level of healthcare services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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, patient experiences (NORPEQ), health-related quality of life, short-term mortality and morbidity, and draws on linkages to national registers. The primary hypothesis is that there is no difference in patient experiences between admissions to a MAW versus a hospital. The secondary hypothesis was that there is no difference in outcomes such as readmission, length of stay, self-assessed health-related quality of life (HRQoL) measured by the EuroQol 5 items 5 level (EQ-5D-5L) index, and health status measured by the RAND-12, between patients admitted to a MAW versus a hospital
Read the 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 use an RCT design, which is a strong study design. The study includes measures of patient experiences and HRQoL. 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 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.
- Conditions
- Patient Experience, Medical Emergencies, Mortality, Morbidity, Co-morbidity, Quality of Life
- Being tested
- Level of healthcare services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level of healthcare servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital | Experimental | 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. Receives: Other: Level of healthcare services |
| Municipal acute ward | No intervention | Patients admitted to decentralized, municipal acute care wards after being assessed by a referring physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 weeks after discharge
Secondary outcomes (8)
30-day Mortality
Number of deaths within 30 days after discharge, all causes
Measured: 30 days
30-day Re-admission
Number of re-admissions to hospital or MAW within 30 days after discharge, all causes
Measured: 30 days
Length of Stay
Number of days patients are admitted to either hospital or MAW
Measured: 8 days
Number of Inpatients Stays
Number of inpatient stays in a healthcare institution
Measured: 3 months
Transfer of Patients Between MAW and Hospital
Number of patients transferred from MAW to hospital
Measured: 1,5 year
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
Measured: 4 weeks after discharge
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.
Measured: 4 weeks after discharge
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
Measured: 1,5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Sep 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patient ExperienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The referring physician in a casualty in the casualty will judge the patients´ eligibility for inclusion, Study nurses in the casualty 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)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Ann-Chatrin Leonardsen, Ostfold University College
- Investigators
- Stefan Sütterlin, Professor, Study chair, Ostfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885206
- Sponsor's protocol ID
- HS2522-40480
- Status last verified
- Aug 2024
- First submitted
- 5 Dec 2018
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03885206
- Acronym / sponsor ID
- HS2522-40480
- Conditions
- Patient Experience, Medical Emergencies, Mortality, Morbidity, Co-morbidity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- 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
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, patient experiences (NORPEQ), health-related quality of life, short-term mortality and morbidity, and draws on linkages to national registers. The primary hypothesis is that there is no difference in patient experiences between admissions to a MAW versus a hospital. The secondary hypothesis was that there is no difference in outcomes such as readmission, length of stay, self-assessed health-related quality of life (HRQoL) measured by the EuroQol 5 items 5 level (EQ-5D-5L) index, and health status measured by the RAND-12, between patients admitted to a MAW versus a hospital
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 use an RCT design, which is a strong study design. The study includes measures of patient experiences and HRQoL. 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The referring physician in a casualty in the casualty will judge the patients´ eligibility for inclusion, Study nurses in the casualty 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.
| Arm | Type | Receives |
|---|---|---|
| Hospital | Experimental | Other: Level of healthcare servicesLevel 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. |
| Municipal acute ward | No intervention | –Patients admitted to decentralized, municipal acute care wards after being assessed by a referring physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level of healthcare servicesPatiens 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. | Other | Hospital |
Primary outcome
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.
8 secondary outcomes
30-day Mortality
Time frame: 30 days
30-day Re-admission
Time frame: 30 days
Length of Stay
Time frame: 8 days
Number of Inpatients Stays
Time frame: 3 months
Transfer of Patients Between MAW and Hospital
Time frame: 1,5 year
Patient Experiences
Time frame: 4 weeks after discharge
Health Status as Assessed With the RAND-12 Instrument
Time frame: 4 weeks after discharge
Eq5D5L
Time frame: 1,5 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Sütterlin, Professor study chair
Ostfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Level of healthcare services in people with Patient Experience and Medical Emergencies, run by Ostfold University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Experiences, NORPEQ (time frame: 2-4 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.