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

The Lovisenberg Open Acute Door Study: a randomised clinical trial of open-door policy services for ward-based, acute psychiatric healthcare services

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16876467
Enrollment
500
Registered
2021-01-29
Start date
2021-02-10
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimisation of violent incidents and of unnecessary coercive measures in acute inpatient treatment of patients with serious psychiatric disorders or states. Mental and Behavioural Disorders

Interventions

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 pr

Sponsors

Lovisenberg Diakonale Sykehus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 - 65 years 2. Referred to acute psychiatric ward from a psychiatric intensive care unit (PICU)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Norway

Contacts

Public ContactHans Martin Nussle
hansmartin.nussle@lds.no+47 23226000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026