Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital: a Multicenter, Randomized Controlled Trial
Phase: NA
Conditions: Patient Experience, Medical Emergencies, Mortality, Morbidity, Co-morbidity, Quality of Life
Sponsor: Ostfold University College

Cover page 
EFFECTIVENESS AND CLINICAL OUTCOMES OF ADMISSIONS TO MUNICIPAL ACUTE 
WARDS VERSUS A GENERAL HOSPITAL: A MULTICENTER, RANDOMIZED CONTROLLED 
TRIAL IN ØSTFOLD COUNTY 
 Date: 01.07.2018 

 
1 
EFFECTIVENESS AND CLINICAL OUTCOMES OF ADMISSIONS TO MUNICIPAL ACUTE 
WARDS VERSUS A GENERAL HOSPITAL: A MULTICENTER, RANDOMIZED CONTROLLED 
TRIAL IN ØSTFOLD COUNTY  
 
1. INTRODUCTION 
 
1.1 The challenge of providing alternatives to hospital treatment 
Demographic changes in the Western world are expected to prompt a need for better organized and more 
efficient health care services (1, 2). In order to curb expenses, 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 (3-5). 
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 (5-7). The 2012 
Coordination Reform (CR) 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 (3). This reform mandates that all 428 Norwegian 
municipalities are obliged to establish Municipal Acute Wards (MAW, Kommunale akutte døgnplasser), so 
as to alleviate pressure on hospitals. However, the initiation of these units is based on political initiatives and 
not on high quality research. Hence, there is little information on the outcomes regarding the quality, cost-
effectiveness, and patient-reported outcomes of this new level of care.  
 
1.2 Our approach  
The proposed study aims at assessing the outcome of admissions to MAWs compared to a general hospital 
for patients in need of acute care, such as acutely sick elderly and patients with exacerbations of chronic 
conditions, that can be treated at a lower and decentralized level of health care, with potentially less 
resources than traditional hospitalizations (8). 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, and short-term mortality, and 
draws on linkages to national registers. A strength of the study is that it is interdisciplinary and cross-
sectoral, and it is founded on national collaboration between researchers with relevant experience and 
representatives from both MAWs and hospitals. Moreover, this intervention is of particular interest for the 
municipalities, and a number of municipalities contribute to this project.   
 
This study will provide essential knowledge for authorities, politicians, healthcare leaders and 
healthcare professionals when developing, implementing and refining decentralized acute healthcare 
services in MAWs, as an alternative to hospitalization. Moreover, it will be essential for user organizations, 
such as LHL, as thorough documentation when speaking up for users. Although the CR is a national 
reform, the results of the project will be of international interest to those working towards better ways of 
organizing healthcare delivery systems. 
 
2. THE RESEARCH PROJECT  
2.1 Background and status of knowledge 
Several models have been developed to meet the future challenges of increased demand for hospital care, 
aiming to ensure integration of services and teamwork in primary health care services, for example 
integrated care units such as community hospitals (CH) and nurse-led units (NLU)(9-11). Findings from 
such units differ substantially: some studies indicate no reduction in hospital admissions (12), while others 
report reduction of early re-admissions and higher costs than for inpatient stays (13).   
          In Norway General Practitioner Hospitals (GPHs) or Community hospitals (CHs) represent a primary 
healthcare level, low technology unit for clinical observations, treatment, rehabilitation and care of patients 
in need of more intensive medical care than can be provided at home or at standard nursing homes when the 
patients do not need general hospital care (14, 15). E.g. GPHs have been shown to contribute to a reduction 
in hospital admissions, improved access to healthcare services in rural areas, and at a lower cost (16, 17). In 
spite of an awareness in many countries of the challenge of finding feasible alternatives to hospitalizations 
for acute care, and hence to reduce costs, there is little scientific evidence for, or evaluation of, alternatives to 
hospitalization. Studies that compare patient outcomes for patients acutely admitted to supplemented primary 
care units (e.g. MAWs) instead of a general hospital are scarce A recent review (18) only identified one 

 
2 
small RCT conducted in Norway (19) and two observation studies conducted in England (20, 21). The 
review concluded: [1] It is possible that admission to a supplemented primary care unit compared with 
hospitalization provides slightly better patient satisfaction, but the quality of the evidence for this result is 
low; [2] There is insufficient scientific evidence to determine whether admission to a supplemented primary 
care unit compared to hospitalization affects patient outcomes, such as physical function and quality of life 
or affects the number of readmissions; [3] No prospective controlled studies that examined whether 
supplemented primary care units lead to fewer hospital admissions, or are associated with reduced expense 
were identified; [4] No studies that compared larger inter-municipal units with smaller were identified.  
Some studies have suggested that patients prefer being treated in a less busy and harried environment 
than in stressful and hectic hospitals, and that patient experiences are more positive in small and rural 
hospitals than in larger and more urban hospitals (22, 23). Recently, a randomized study of 60 patients in 
rural Norway compared the health consequences of acute admission to a small community hospital unit 
(n=33) as an alternative to a general hospital (n=27), The study found no differences in daily functioning or 
health consequences between the groups, though the community hospital patients had fewer in-patient days 
at hospitals and nursing homes and less use of home nursing than those admitted to the general hospital (24). 
The study included few patients, resulting in no significant findings. This RCT can be seen as a “pilot” to our 
planned study, and the researcher of this RCT also takes part in this new study.           
The municipalities will play a central role in meeting the growth in demand for healthcare services in 
Norway (4, 25). As of 1 January 2016, all Norwegian municipalities are obliged to have in place a MAW in 
order to reduce the pressure on hospitals. The MAWs are designed for patients diagnosed with conditions 
that can be managed with less advanced equipment than in hospital, without reducing treatment quality. 
These units offer 24-hour acute treatment and care service within the municipality, to people in need of 
necessary, urgent and immediate help, as wards with an anticipated length of stay less than 72 hours (26). A 
recent study reported that the establishment of MAWs in Norway reduced general hospital admissions, 
especially for people 80 years or above, and where the MAW was co-located with a casualty and had a 
physician present 24/7 (27). Moreover, MAWs have been shown to deliver safe and quality, patient-centered 
healthcare services from patients’ perspectives (28, 29). The MAWs represent somehow different services 
than the ICUs, GPHs and community hospitals, since the MAWs are meant to be an alternative to acute 
hospitalization, while the other units are services prior to and after hospitalization, or used for rehabilitation.   
As far as we know, 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.  
 
2.2 Overall study design: a randomized controlled trial 
Patients selected for treatment in a MAW are presumed to be less severely ill than those treated in the 
hospitals, and the staffing, diagnostic and monitoring facilities are more limited than in the hospital. 
Therefore there is a selection bias that represents a challenge when comparing treatment in MAWs and 
hospitals. In order to compare treatment between MAWs and adjust for observable and non-observable 
bias and confounding, an RCT would be feasible. RCTs are the most rigorous way of determining whether 
a cause-effect relation exists between an intervention and an outcome (30), yet such studies have been 
underutilized in the health care services research.  
Therefore, the study is designed as an RCT of the effectiveness and quality of care in five MAWs, 
compared to one hospital in Østfold County. The study will be a large, open, parellel group RCT, which 
aims to include a minimum of 700 patients. In order to reduce the additional workload on the hospital, we 
shall use a 2:1 allocation to the MAWs and hospital, respectively.  
 
2.3. The study’s objectives 
The primary outcome of the study will be patient experience, as measured with the Nordic Patient 
Experience Questionnaire-The NORPEQ, which is a validated, reliable short form questionnaire including 
eight questions to measure patient experiences covering important aspects of the healthcare service delivery, 
such as communication, information, trust and care, as well as overall satisfaction (31).  
 
The null hypothesis states that there is no difference in patient experiences between the two allocation 
groups.  
In addition the study will compare a number of secondary outcomes between the study arms: 

 
3 
• 
Change in HRQoL from inclusion to 4 weeks, as assessed with the EQ-5D Index utility measure 
(32).  
• 
30-day mortality  
• 
30-day readmission rate (all causes) 
• 
Length of stay and number of inpatient days over 3 months (all causes) 
• 
Transfer of patients between the MAW and the hospital 
• 
Patient experiences, using the NORPEQ questionnaire, 4 weeks after inclusion 
• 
Health status as assessed with the RAND-12 instrument 
• 
Costs and cost-effectiveness 
• 
Variation in practice between the five MAWs  
Moreover, the study will aim at further exploring General Practitioners’ perspectives on these issues, and on 
the quality, safety and efficiacy of the MAWs (see section 2.7).   
 
2.4. Patient perspectives 
There is a growing recognition that patients’ perspectives are essential in designing health care services, and 
in the assessment of the effectiveness and quality of health care (33). The planned study will assess 
effectiveness using patient-reported outcomes.  
At the time of admission, the patients will be asked to complete an interviewer-administered EQ5D- 
three level version (EQ-5D-3L) as a baseline measure. Four weeks after inclusion, the patients will be 
contacted by telephone to respond to the EQ-5D-3L and the NORPEQ questionnaires: 
The EQ-5D-3L is a generic measure of health status that provides a simple descriptive profile and a 
single index value that can be used in the clinical and economic evaluation of health care, and in 
population health surveys. The EQ-5D-3L consists of the EQ-5D descriptive system and the EQ visual 
analogue scale (EQ VAS) (32). The items are aggregated to a utility index, the EQ-5D Index. 
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. 
 
2.5. User involvement 
We have established close links with representatives from the health care services in the municipalities, 
including in the steering group, as well as users from Landsforeningen for Hjerte- og Lungesyke, LHL. For 
successful inclusion of patients in the project, it is crucial to have good support in the local communities.  
Patient participation is increasingly recognized as a key component in the design of health care 
processes and in improving patient safety (34). In the planning of this project, patient representatives from 
LHL, and a representative from the Consumer board (Brukerutvalget) at Østfold Hospital Trust have 
participated and provided constructive input in project meetings. In addition, a patient representative from 
LHL will provide input and critique to the planning of the project, specifically patient information and 
inclusion procedures. Moreover, users will be essential when planning utilization and publication of the 
findings.  
 
2.6. General Practitioners’ perspectives 
Patients admitted to MAWs are referred by a General Practitioner (GP), a casualty- or a nursing home 
physician. A recent study from Østfold found that GPs found several aspects of MAW services problematic, 
including challenges in deciding which patients were suitable for treatment 
at a MAW, whether patients could be regarded as medically clarified, and whether these services were 
sufficient and safe. GPs were also under pressure from several other stakeholders when deciding where to 
refer their patients. Moreover, the MAWs were viewed not merely as an alternative to hospitals, but also as a 
service in addition to hospitals (35). These aspects have an impact on whether MAWs are used as intended 
or not. Further investigation of GPs’ perspectives on MAWs will be included in the Post-docs’ research 
approach.  
 
3. THE PROJECT PLAN, MANAGEMENT, ORGANIZATION AND COOPERATION 
 
3.1. Project plan and data collection 
Sample and inclusion 
The study will be conducted in Østfold county, which include 17 municipalities belonging to the same 

 
4 
hospital catchment area of approximately 290 000 inhabitants. In Østfold, five MAWs have been 
established during the period 2012-2013. The MAWs concict of from six to 11 beds, and are located both 
rural and central. 
In a pilot study all patients who are admitted to the five MAWs during 2 weeks, will be presented 
with patient information about a preliminary fictive study, whether they would be willing to participate in 
such a potential proposed (theoretical) study, asked to respond to some questionnaire items, and finally 
provide comments to the process. This to ensure that inclusion will be possible.  
Statistics from the five MAWs in Østfold collected throughout the last five years, shows that 
approximately 60% of the patients are referred from one of the five casualties (Legevakt). All patients who 
otherwise would have been hospitalized, and who are judged to fulfill the criteria for admission at a MAW 
by a physician at the local Casualty (Legevaktslege) will be invited to participate. Those fulfilling the 
inclusion criteria will be randomized for admission either to a MAW or the hospital.  
 
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 physician at the local Casualty (Legevakt) on the same day  
 
Exclusion criteria: 
• 
Psychiatric or cognitive impairment 
• 
No Norwegian national identification number 
• 
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  
 
The diagnostic loop is a service by the hospital offering the GPs an opportunity to send patients to the 
hospital for examinations and diagnostic work-up, e.g. with x-rays, and then further to the MAW. Patients 
admitted via this pathway will be registered, but they will not be included in the RCT. 
 
The referring physician will contact one of the five MAWs after having judged the patients´ eligibility 
for inclusion, and received patients´ written informed consent to participate. The MAWs will then randomize 
the patients to either the MAW or the hospital, using a simple randomization procedure with numbered 
sheets in sealed, opaque envelopes. The randomization will be done by personnel responsible for receiving 
referral by telephone, either a physician or a nurse, at the MAWs. The patients will then be transported to the 
MAW or hospital according to the random allocation procedure. 
 
  
Variables collected 
The referring physician will fill in a screening form before allocation, including date, time, age, sex, ICPC2 
diagnosis and a checklist of the inclusion/exclusion criteria. These forms will be kept as part of the case 
report form (CRF) for those included, and as a reject log for those excluded. At admission to the allocated 
unit, a minimum of additional data will be collected: EQ-5D-3L profile and VAS by interview, Modified 
Early Warning Score including the raw data (MEWS; a measure to judge the severity of a patient’s 
condition), demographic variables, ID of treating hospital department or MAW, and number of 
hospitalizations (and localization) during the past 6 months. At 4 weeks (range 3-6 weeks) after inclusion, 
the patients will have a follow-up by telephone, being interviewed with the EQ-5D-3L and the NORPEQ, 
and present location (home/nursing home/rehabilitation), and whether a proxy assisted with responding to 
the phone interview. 
All included patients’ electronic medical records at the MAWs and the hospital will be reviewed 
after discharge to record a number of variables, such as previous diagnoses (comorbidity), previous number 
of admissions and inpatient days during the past year, whether the patient was admitted from the home or 
nursing home, treatments given, diagnoses at discharge, re-admissions and deaths. In addition the project 
will ask for consent to use the national personal identification number (PIN) of each patient for linkage with 
information of the Norwegian Patient Register (Norsk pasientregister, NPR), the Cause of Death Register of 
Statistics Norway (Dødsårsaksregisteret), and the Norwegian Prescription Database (Reseptregisteret). 
The Charlson comorbidity index (CCI), a method of predicting mortality by classifying or weighting 
comorbid conditions, will be used to control for comorbidity as a potential confounding variable when 

 
5 
comparing patient-reported outcomes in the MAWs and hospital wards. This method has been widely used by 
health researchers to measure burden of disease and case mix (35). In the present study, CCI will be scored 
on the basis of review of medical records at the MAWs and the hospital, and validated against diagnosis 
codes from previous hospital stays.   
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)].  
 
Sample size  
In a recent study (36) utilized the NORPEQ to validate the Picker Patient Experience Questionnaire (PPE-
15) in Norwegian. In this study the mean score in MAWs was 0.83 (Standard deviation, SD, .13), while the 
score in hospital was 0.78 (SD .13).  Following a superiority design, 2:1 allocation to the MAW and hospital 
respectively, power=0.8, alpha=0.05, we estimated the required sample size to be able to detect a mean 
difference between the groups of 0.25 standard deviation (SD). Adjusted for potential drop-outs (5% dead, 
15% non-response to follow-up) this gives a sample size of 340 patients in MAWs and 160 patients in 
hospital. The mortality rate seems realistic, as over 2 months in 2015 the 30-day mortality rate was 5% in 
total for one of the largest MAWs in Østfold County.  
 
Recruitment schedule 
In 2018 about 2,300 unique patients were admitted to the five MAWs in Østfold county, and the annual 
number of admissions is expected to increase during the next years. Patients may not be eligible for 
inclusion, may be excluded, or may reject to participate because they have a preference for being treated in 
their local community (24), for the most advanced treatment, or the may opt to avoid unnecessary 
transport to another facility. Given extensive encouragement and support in the recruitment process, we 
anticipate that it is possible to include the needed amount of patients over 12 months. The duration of the 
inclusion period in the project will be a maximum of 15 months.  
 
Statistical analysis 
Groups will be compared using the Student’s t test, Mann-Whitney U or chi-square test, as appropriate. 
Change in the EQ-5D-3L index (the primary outcome) will be compared using the Student’s t test. The 
distributions of scores on the EQ-5D dimensions at follow-up will be compared using the Mann Whitney U 
test.  30-day mortality rate will be compared between groups using the chi square test or multivariable logistic 
regression analysis. 
Similarly, average cost per disease episode will be compared between the two study arms using the t 
test. LOS will be compared using the Mann-Whitney U-test, or multivariable negative binomial regression 
analysis.  
A priori, we assume a 20% crossover rate of patients from the MAWs to the hospitals. Analyses will 
be based on the intention-to-treat principle where possible. In some of the secondary analyses, we shall 
control for potential confounding factors such as gender, age and co-morbidity to reduce bias.  
 
3.2. Project management and organization 
The project has been established in collaboration between the Østfold Hospital Trust, Østfold College, the 
five inter-municipal MAWs, the 17 municipalities in the Østfold county, Helse Sør-Øst Centre for Health 
Services Research (HØKH, Akershus University Hospital), and the University of Oslo. The project has 
been planned by a working group in consultation with an advisory board consisting of experienced 
researchers, physicians from three of the MAWs in Østfold County and users. The project will be organized 
with a project group, project supervisors/investigators, and an advisory board. The researchers established 
contact with LHL at an early point, and user representatives have participated in project planning.  
Statistical support is available at the Department of Research, Østfold Hospital Trust, HØKH, as 
well as the University of Oslo. HØKH has skilled researchers with a competence in methodology, health 
economics, and clinical medicine, and the project will draw on their expertise.  
 
3.2.1 The project group and roles 

 
6 
The following positions will be funded by the project: 
PhD student. Nystrøm will primarily be employed at the Østfold University College during the 
study. The student will take responsibility for applications for data linkage, data collection, including follow-
up and support of the randomization and inclusion process, review of medical records, data analysis and 
publications, in addition to completing the mandatory courses for the PhD. She/he will be involved in 
follow-up of data collection in the Emergency department of the hospital and the MAWs in collaboration 
with the project coordinators/research assistants.  
Project coordinators/research assistants. At each of the MAWs, we will aim at engaging a dedicated 
research assistant. They will be located at each of the MAWs and will be involved in randomization, data 
collection and general support, with a focus on daily follow-up with the PhD candidate, the Emergency 
department of the hospital and the MAWs.  
 
3.2.2 Project supervisors/collaborators 
Main supervisor. Dr Ann-Chatrin Linqvist Leonardsen, associate Professor Østfold University 
College and Podt-doc at Østfold Hospital trust. Dr Leonardsen will be the main supervisor for the PhD 
student. She holds her PhD in health-service research and was one of the first Norwegian researcher focusing 
on the effects of the collaboration reform. She has excellent knowledge of the primary care health service in 
Østfold County and a well-renowned network within the field of health-service research. As a post-doc 
fellow at Østfold Hospital Trust (20%) dr. Leonardsen will assist during inclusion of patients and co-write 
relevant papers, as well as resume responsibility for 1-2 of the remaining papers.  
Co-supervisor Tron Moger, Professor University of Oslo will be co-supervisor for the PhD student. 
Dr Moger has done extensive research within the field of health economics. He is specialized in the field of 
cost-effectiveness analyses. Dr. Moger will assist in data analyses and relevant scientific papers. 
Co-supervisor Hilde Lurås, Associate Professor University of Oslo will be co-supervisor for the PhD 
student. Lurås has done extensive research within the field of effects of organization, patient pathways and 
collaboration in healthcare services, as well as in health economics. Dr Lurås will assist in data analyses, 
writing and publication.  
Research collaborators: 
Co-investigator. Professor Terje Hagen, University of Oslo. With his extensive research experience 
within the field of health service research and health economics, professor Hagen will contribute to this 
project in data analyses and scientific input on relevant papers. 
Co-investigator. Professor Patrik Midløv University of Lund, Sweden. Professor Midløv has 
extensive experience in the field of health-service research, as well as in primary care research. He holds the 
position as professor and chief of primary care research at Lund University, Sweden. Professor Midløv will 
contribute to this project through data analyses and scientific input on the papers. 
Co-investigator. Øystein Lappegard, MD, PhD. Dr. Lappegard took his PhD on «Acute admissions 
at Hallingdal sjukestugu: Can and should local medical centres play a role in Norwegian healthcare services 
for acute admissions of a specified group of patients?». His experience with complex health-service research 
designs will be valuable for the PhD student. Dr Lappegard will provide help in data analyses and 
interpretation of findings. 
 
3.4 Budget 
The PhD candidate will be financed through fundings from Extratsiftelsen. Leonardsen has received a 
finance guarantee for three years from Østfold Hospital Trust. Lurås and Moger will be financed through 
internal research time in their employments at UiO, respectively.  
 
3.5 Time schedule 
 
 2018 
 
2019 
 
2020 
 
2021 
2022 
 July-Dec 
Jan-
Jun 
July-
Dec 
Jan-
Jun 
July-
Dec 
Jan-
July 
July-
Dec 
Jan-
July 
July-
Dec 
Project planning & 
protocol 
  
 
 
 
 
 
 
 
Applications 
  
 
 
 
 
 
 
 
Employment of PhD 
candidate-12/6-19 
  
 
 
 
 
 
 
 
Inclusion period 
                             
 
 
 
 
 
 
 

 
7 
PhD courses, 
 
 
 
 
 
 
 
 
 
Data cleaning, 
analysis 
  
           
 
 
 
 
 
 
Presentations/abstracts 
 
  
        
 
 
 
 
Paper I:  
 
              
 
 
 
 
 
Paper II: 
 
 
  
 
 
 
 
Paper III: 
 
 
  
 
 
 
 
 
PhD thesis 
 
 
 
  
 
 
 
 
Paper IV (post-doc) 
 
 
  
       
 
 
 
 
 
 
4. KEY PERSPECTIVES AND RELEVANCE TO HELSEVEL 
 
4.1 Compliance with strategic documents  
The study builds on recent research on MAWs in Østfold county, and on an established collaboration between 
researchers and participants from both municipalities, hospital and educational institutions as well as research 
groups both nationally and internationally. The study includes measures of HRQoL and patient-experiences, 
as well as data from national registers, and has a comparative approach. The project incorporates users from 
LHL and the hospital consumer board 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 (3, 7, 37). Finally, health services research is a prioritized area for the owners of 
the Østfold Hospital Trust, HSØ.  
 
4.2 Relevance and benefit to society  
The study will provide important knowledge about structural, organizational and economic aspects of acute 
healthcare services, exploring the effectiveness and outcomes in MAWs versus a general hospital, including 
HRQoL, quality of care, cost-effectiveness and patient experiences/satisfaction, as well as GPs perspectives 
on these issues. These outputs will be important for authorities, politicians, health care leaders, and 
professionals as well as researchers involved in developing, implementing and refining decentralized acute 
health care services as an alternative to hospitalization. In addition these outputs are important 
documentation for user organizations (such as LHL), when speaking up for their members.  
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 that have 
previously undertaken similar but different approaches to decentralize health care and reduce the costs of 
acute hospitalizations. 
 
4.3 Ethical perspectives  
Ethical approval has been granted from the Regional Committee for Medical Ethics (reference no. 2018/687) 
, as well as the Norwegian Center for Research Data (NSD, reference no. 340271). The project will be based 
on the principles stated in the declaration of Helsinki. All data will be anonymized and treated in strict 
adherence to prevailing regulations. All participants will be informed that participation is voluntary and of 
their right to withdraw at any stage, and fully informed consent will be collected prior to their enrolment and 
randomization. The consent will include that the researchers are allowed to gather needed information from 
the patients´ medical records in the MAW and Norwegian hospitals, and through linkage to national registers.  
 
4.4 Gender issues  
The results of this project will be of relevance to both women and men. The research team has a good gender 
balance and will endeavor to maintain this when employing the PhD candidate, Post-doc. candidate, and co-
workers. 
 
5. DISSEMINATION AND COMMUNICATION OF RESULTS 
The study will lead to at least five high quality scientific publications in peer-reviewed journals in English, 
of which three articles will be part of fulfillment for the PhD thesis of the PhD candidate. 
Some tentative titles for publications from the study that relate to the objectives described above:  
(1) Health-related quality of life after admissions to municipal acute wards versus a general hospital: a 
multicenter, randomized controlled trial 

 
8 
(2) Patient experiences following admissions to municipal acute wards versus a general hospital:  a 
multicenter, randomized controlled trial 
(3) Cost-effectiveness of admissions to municipal acute wards versus a general hospital: a multicenter, 
randomized controlled trial 
(4) Comparison of 30-day mortality and health care utilization for admissions to municipal acute wards 
versus a general hospital:  a multicenter, randomized controlled trial 
(5) Variations in structure, processes and healthcare utilization between municipal acute wards in Østfold 
County. GPs’ perspectives and impact.  
(6) Variations in health-related quality of life and patient experiences between five municipal acute wards: a 
descriptive study  
 
The project group includes merited researchers, thus ensuring that publication in high-impact journals is 
achievable. The protocol, planning, progress reports, and results from the study will be presented as oral 
presentations or posters at national and international conferences. The target audience will be scientific 
peers, administrators, government, and politicians, as well as representatives for various patients’ consumer 
groups. A web-site and social media, such as Facebook, will also be used to spread information about the 
progress and results from the study to users and the general public. An anticipated time schedule for the 
various study outputs is shown above in the project plan (item 3.5.) 
 
6. ADDITION INFORMATION REQUESTED IN THE CALL FOR PROPOSALS  
Expected benefit. 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 intermediate level 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 we 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 
interest to smaller cities and rural areas. In a national health service striving to curb expenses of hospital 
care, the study results on cost-effectiveness will be of particular interest and have a benefit for the 
authorities, politicians, and healthcare professionals when developing that are engaged in implementing and 
refining the MAW concept.  
User involvement. In this project the patients, relatives, municipalities and their representatives 
constitute the users. The project has established close links with representatives from the healthcare 
services in the municipalities that have participated in project planning and expressed strong support to the 
project. The municipalities’ healthcare personnel will participate in the inclusion of patients, and this 
commitment is crucial for the success of the project. The municipalities are also represented in the advisory 
board. Patient participation is a key component in the design of health care processes and in improving 
patient safety (34). In the planning of this project, patient representatives from LHL and a representative 
from the Consumer board (Brukerutvalget) at Østfold Hospital Trust have participated and provided 
constructive input. In addition, patients will provide input and critique to the patient information and 
inclusion procedures.  
 
References 
 
1. 
European Comission. Long-term care in the European Union. Brussels: Directorate-
General for Employment, Social Affairs and Equal Opportunities; 2008. 
2. 
Folkehelseinstituttet. Helsestatistikk/folkehelseprofiler 2015 [Web page]. Available 
from: http://www.fhi.no/helsestatistikk/folkehelseprofiler. 
3. 
The Norwegian Department of Health and Care. Samhandlingsreformen. Rett 
behandling-til rett tid-på rett sted [The Coordination Reform. proper treatment-in right time 
and place] The Norwegian Department of Health and Care; 2009 [Available from: 
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