Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide

Suicidal Ideation Clinical Trial

— BAS  

Official title:

Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985047
• Other study ID #: 2014/570
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: August 10, 2018

Study information

• Verified date: August 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline Personality disorder. Participants will be allocated to BA + Treatment as Usual (TAU) or TAU.

Description:

When individuals with recurrent self-harm and suicidal behaviour seek acute admission to hospital due to a crisis and associated increased suicidal ideation, recommendations for clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are considerable, and long hospital admissions without a clear treatment structure may predict decompensation in functioning. This has resulted in a clinical practice of avoiding admission for individuals diagnosed with Borderline Personality Disorder (BPD).

Brief admission (BA) as an intervention has a longstanding history in the delivery of mental health services in the Netherlands. The core elements of brief admission were determined through consultation with Dutch researchers, interviews with individuals with experience, Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar with implementing this crisis management intervention. Core elements of the intervention were standardized into a protocol, and an educational manual was developed to train clinicians involved in the trial. An objectively rated fidelity measure was developed in order to ensure adherence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 10, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Current episodes of self-harm and/or recurrent suicidality.

• Fulfilling at least three criteria for borderline personality disorder.

• Admitted to psychiatric hospital for acute care for at least 7 days or presenting to the psychiatric emergency department at least 3 times during the last six months.

Exclusion Criteria:

• No regular contact with outpatient psychiatric services.

• Homelessness. Housing crises are outside the scope of this RCT.

• Medical disorder from other organs that significantly contributes to inclusion criteria (e.g. if self-harm only occurs during episodes of hypoglycemia in a diabetic patient).

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Emergencies
• Emergency Services, Psychiatric
• Personality Disorders
• Self-Injurious Behavior
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Other:
• Brief Admission
Participants randomised to Brief admission (BA) will participate in a negotiation together with their out-patient clinician and a representative from the ward. The aim of the negotiation is to form an individualised contract defining how BA will work for them. After signing the contract, will have the possibility to admit themselves to hospital according to the procedure stated in the contract.

Locations

Country	Name	City	State
Sweden	Division of Psychiatry, Region Skåne	Lund	Skåne

Sponsors (3)

Lead Sponsor	Collaborator
Region Skane	Lund University, Radboud University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days with hospital admission	Number of days with Brief admission, general admission, forced (involuntary) admission	Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Secondary	Frequency of forced acts (e.g. restraints and forced medication)		Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Secondary	Individuals' Experiences of the intervention	Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)	Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
Secondary	Clinicians' Experiences of the intervention	Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)	Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
Secondary	Frequency of all self-harming behaviours including suicide attempts	Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)	Change in frequency between baseline, 6 months and 12 months prospectively.
Secondary	Severity of self-harming behaviours	Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)	Change in severity between baseline, 6 months and 12 months prospectively.
Secondary	Level of functioning in activities of daily life	The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)	Change in ratings between baseline, 6 months and 12 months prospectively.
Secondary	Ability to cope effectively with life stress	The Brief COPE	Change in ratings between baseline, 6 months and 12 months prospectively.
Secondary	Ability to regulate emotions	The Difficulties in Emotion Regulation Scale	Change in ratings between baseline, 6 months and 12 months prospectively.
Secondary	Global psychiatric symptoms	Outcome from Clinical Global Impression Severity Scale	Change in ratings between baseline, 6 months and 12 months prospectively.
Secondary	Satisfaction with health care	Client Satisfaction Questionnaire (CSQ)	Change in ratings between baseline, 6 months and 12 months prospectively.