Co-morbidity, Medical Emergencies, Morbidity, Mortality, Patient Experience, Quality of Life
Conditions
Brief 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, 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.
Interventions
OTHERLevel 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.
Sponsors
Extrastiftelsen, Akersgatab28, No-0158Oslo, Norway
The National Association for Heart and Lung Disease, Jessheim, Norway
University of Oslo
University Hospital, Akershus
Ostfold Hospital Trust
Ostfold University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experiences, NORPEQ | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day Re-admission | 30 days | Number of re-admissions to hospital or MAW within 30 days after discharge, all causes |
| Length of Stay | 8 days | Number of days patients are admitted to either hospital or MAW |
| Number of Inpatients Stays | 3 months | Number of inpatient stays in a healthcare institution |
| 30-day Mortality | 30 days | Number of deaths within 30 days after discharge, all causes |
| Patient Experiences | 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 |
| Health Status as Assessed With the RAND-12 Instrument | 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. |
| Eq5D5L | 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 |
| Transfer of Patients Between MAW and Hospital | 1,5 year | Number of patients transferred from MAW to hospital |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 49 |
| Municipal Acute Ward Patients admitted to decentralized, municipal acute care wards after being assessed by a referring physician. | 115 |
| Total | 164 |
Baseline characteristics
| Characteristic | Hospital | Municipal Acute Ward | Total |
|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 19.9 | 70.7 years STANDARD_DEVIATION 20.6 | 69.6 years STANDARD_DEVIATION 20.4 |
| EQ-5D index | 0.3 units on a scale STANDARD_DEVIATION 0.4 | 0.3 units on a scale STANDARD_DEVIATION 0.4 | 0.3 units on a scale STANDARD_DEVIATION 0.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 29 Participants | 77 Participants | 106 Participants |
| Sex: Female, Male Male | 20 Participants | 38 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 49 | 4 / 115 |
| other Total, other adverse events | 0 / 49 | 0 / 115 |
| serious Total, serious adverse events | 0 / 49 | 0 / 115 |
Outcome results
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.
Time frame: 2-4 weeks after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hospital | Patient Experiences, NORPEQ | 78.7 units on a scale | Standard Deviation 15.5 |
| Municipal Acute Ward | Patient Experiences, NORPEQ | 80.9 units on a scale | Standard Deviation 9.8 |
Secondary
30-day Mortality
Number of deaths within 30 days after discharge, all causes
Time frame: 30 days
Secondary
30-day Re-admission
Number of re-admissions to hospital or MAW within 30 days after discharge, all causes
Time frame: 30 days
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
Time frame: 1,5 year
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.
Time frame: 4 weeks after discharge
Secondary
Length of Stay
Number of days patients are admitted to either hospital or MAW
Time frame: 8 days
Secondary
Number of Inpatients Stays
Number of inpatient stays in a healthcare institution
Time frame: 3 months
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
Time frame: 4 weeks after discharge
Secondary
Transfer of Patients Between MAW and Hospital
Number of patients transferred from MAW to hospital
Time frame: 1,5 year