The Lovisenberg Open Acute Door Study (LOADS): a trial of an open-door policy for psychiatric wards

ISRCTN	ISRCTN16876467
DOI	https://doi.org/10.1186/ISRCTN16876467
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	RCN 309903
Sponsor	Lovisenberg Diakonale Sykehus
Funders	Norges Forskningsråd, Helse Sør-Øst RHF

Submission date: 29/01/2021
Registration date: 29/01/2021
Last edited: 11/03/2024

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Freedom of movement is a fundamental human right that is systematically restricted in acute psychiatry to address safety, prognosis and/or staffing concerns. The legitimacy and therapeutic impact of the current state-of-the art ‘locked door’ practice has recently been called into question by the United Nations, the WHO, user organisations, and the Norwegian Government. In this study, the Lovisenberg Diaconal Hospital will implement and test a new service model, open-door policy, to investigate their potential to reduce coercion on our inner-city acute psychiatric wards.

Who can participate?
Adults 18 - 65 years, referred to an acute psychiatric ward from a psychiatric intensive care unit.

What does the study involve?
In this healthcare services RCT, the Lovisenberg Open Acute Door Study (LOADS), staff will randomly assign admitted acute psychiatric patients to two open-door policy wards or three state-of-the-art locked-door wards for 12 months. The RCT will be followed by a 4-year observational period to report on any post RCT effects on violent and coercive events, patient feedback, or the treatment stay (duration, type/intensity of treatments received, readmission). All wards are located in the same building facility at Lovisenberg campus in Oslo, Norway. The hypothesis is that open-door care will be equivalent to locked-door care on safety and coercive measures, and equivalent- or superior to locked-door care on patient experiences of treatment.

What are the possible benefits and risks of participating?
The benefit may be an improvement in care.
The risk of participating in any study arm can be considered equivalent to or better than standard care, as Lovisenberg's regular (locked-door) services have previously been acclaimed for user-orientation and ability to minimise coercion.
Standard clinical data (including patient feedback/experience measures) will be utilised.

Where is the study run from?
Lovisenberg Diaconal Hospital Clinic of Psychiatry (Norway)

When is the study starting and how long is it expected to run for?
February 2020 to December 2025

Who is funding the study?
1. Lovisenberg Diaconal Hospital (Norway)
2. The Research Council of Norway
3. The South-Eastern Norway Regional Health Authority

Who is the main contact?
Nikolaj Kunøe, nku@lds.no

Contact information

Mr Nikolaj Kunøe
Scientific

Lovisenberg Diaconal Hospital
Postboks 4970 Nydalen
Oslo
0440
Norway

ORCID ID	0000-0003-4530-2021
Phone	+47 23226000
Email	nku@lds.no

Mr Hans Martin Nussle
Public

Lovisenberg Diaconal Hospital
Postboks 4970 Nydalen
Oslo
0440
Norway

Phone	+47 23226000
Email	hansmartin.nussle@lds.no

Study information

Primary study design	Interventional
Study design	Interventional randomized controlled single-centre study with observational follow up
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The Lovisenberg Open Acute Door Study: a randomised clinical trial of open-door policy services for ward-based, acute psychiatric healthcare services
Study acronym	LOADS
Study objectives	An open-door policy service model does not cause more incidents of violence, coercive measures or suicide than a standard, locked-door service model.
Ethics approval(s)	Approved as a healthcare services study with exemption from consent requirements on 02/02/2020, Regional Ethical Committee South-East D (P.O. Box 1130, Blindern, 0318 Oslo, Norway; +47 22 84 55 11; rek-sorost@medisin.uio.no), ref: 29328
Health condition(s) or problem(s) studied	Minimisation of violent incidents and of unnecessary coercive measures in acute inpatient treatment of patients with serious psychiatric disorders or states.
Intervention	All patients referred to acute ward care from an admissions ward or psychiatric intensive care unit (PICU) are randomly allocated to either: 1. Two wards with an open-door policy service model that provides peer service workers, treatment planning based on open dialogue with next of kin or collaborating outpatient/city services, and free mobility during daytime hours (09.00-21.00) through the ward door (contingent on frequent, accurate risk assessment) 2. Three wards with a standard, locked-door policy including de-escalation training. As a healthcare services trial, the type and duration of interventions are applied by ward staff based on individual assessment of the patient's needs. To minimise the ethical and clinical burden of random allocation of patients to wards, patients returning from a recent (2020) admission are allocated using a 'home ward' principle, while new patients are allocated using a randomisation list. This randomised phase lasts 12 months, after which an observational phase commences during which more wards adopt the open-door policy model provided study hypotheses are supported. Standard acute ward observational statistics will be collected for monthly, quarterly, and annual reports for 4 years on violent and coercive events, types and doses of treatments, length of stay, unauthorised leave/absconding, patient feedback measures, readmission (time to- and general rates). The design permits pre-post analyses of effects as well as randomised parallel groups comparisons.
Intervention type	Behavioural
Primary outcome measure(s)	Number of patient stays with one or more coercive measures (including involuntary medication, isolation/seclusion, mechanical- or manual/physical restraints) is measured by summarising registered coercive measures per study arm in patient records at 12 months (RCT), and (observational) 24, 36, and 48 months
Key secondary outcome measure(s)	1. Violent events, including suicides, are measured using the hospital incident registry at 12 months, 24, 36, and 48 months 2. Individual coercive measures (including medications, seclusion, mechanical or manual/physical restraints) are measured using patient records and summarised at 12 months, 24, 36, and 48 months 3. Duration of separate involuntary/coercive measures are measured in patient records at 12 months (RCT), and (observational) 24, 36, and 48 months 4. Patients' experience of coercion and treatment environment are measured by patient-reported experience measures (PREMs) continuously and summarised at 12 months, 24, 36, and 48 months 5. Absconding from inpatient care is measured in the patient records of all involuntarily admitted patients at 12 months (RCT), and (observational) 24, 36, and 48 months 6. Type and extent of in-building use of illicit substances and alcohol abuse is measured by continuous on-site measuring of substances and metabolites in wastewater and comparing this to baseline (2020) samples. 7. Type and extent of pharmaceutical treatments are measured by patient records at 12 months (RCT), and (observational) 24, 36, and 48 months 8. The amount of time main doors are open to patients (as opposed to locked due to emergencies) is measured using in-ward door records at 12 months (RCT), and (observational) 24, 36, and 48 months
Completion date	31/12/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	500
Total final enrolment	556
Key inclusion criteria	1. Adults aged 18 - 65 years 2. Referred to acute psychiatric ward from a psychiatric intensive care unit (PICU)
Key exclusion criteria	1. Forensic category patient (assessed as having a high risk of committing violence) 2. Police or criminal justice custody patient without legal option to utilise the open-door service
Date of first enrolment	10/02/2021
Date of final enrolment	31/12/2025

Locations

Countries of recruitment

Norway

Study participating centre

Lovisenberg Diaconal Hospital Clinic of Psychiatry

Lovisenberg Diakonale Sykehus
Postboks 4970 Nydalen
Oslo
0440
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available. The Privacy Ombudsman of Lovisenberg Diaconal Hospital has requested participant-level data not be made available to external parties due to the sensitive nature of psychiatric diagnoses and acute psychiatric admissions.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		06/03/2024	07/03/2024	Yes	No
Protocol article		16/02/2022	17/02/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/03/2024: Total final enrolment added.
07/03/2024: Publication reference added.
17/02/2022: Publication reference added.
29/01/2021: Trial’s existence confirmed by Regional Ethical Committee South-East D (Norway).