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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424509
Other study ID # 2024-00589-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date January 1, 2027

Study information

Verified date June 2024
Source Lund University
Contact Sofie Westling, MD, PhD
Phone +46735626099
Email sofie.westling@med.lu.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The current study aims to evaluate the impact of long (>5 days) and/or compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm. The basis for this study is the diversity of clinical practices across Swedish regions. By categorizing clinics based on their practices with respect to long and/or compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides. All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022). Data collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. The participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with BPD. The top quartile of participants will be compared with the bottom quartile.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 390
Est. completion date January 1, 2027
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Psychiatric clinic in Sweden authorized to administer compulsory care for adults. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022). Exclusion Criteria: - No authorization to administer compulsory care for adults

Study Design


Intervention

Other:
High degree of long (>5 days) and/or compulsory psychiatric inpatient care
High degree of long (>5 days) and/or compulsory psychiatric inpatient care

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Lund University Linkoeping University

Outcome

Type Measure Description Time frame Safety issue
Primary Number of healthcare visits due to self-harm Number of healthcare visits due to self-harm in specialized inpatient or outpatient care, as defined in the NPR (X60-X84; Intentional self-harm) divided by the number of individuals diagnosed with BPD per clinic and calendar year. 1 year
Primary Number of deaths by suicide Number of deaths by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) in individuals diagnosed with BPD divided by the number of individuals diagnosed with BPD per clinic and calendar year. 1 year
Primary Number of deaths by suicide within 30 days after discharge Number of deaths by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) within 30 days after discharge, in individuals diagnosed with BPD divided by the number of individuals diagnosed with BPD, per clinic and calendar year 1 year
Secondary Number of days between admissions to psychiatric inpatient care Number of days between admissions to psychiatric inpatient care for people diagnosed with BPD divided by the number of individuals diagnosed with BPD per clinic and calendar year. 1 year
Secondary Number of days between death by suicide and discharge Number of days between death by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) and discharge in individuals diagnosed with BPD. For this variable, death by suicide during inpatient admission will be labelled 0. 1 year
Secondary Number of days in somatic (non-psychiatric) inpatient care after self-harm Number of days in somatic (non-psychiatric) inpatient care after self-harm (X60-X84; Intentional self-harm) divided by the number of individuals diagnosed with BPD per clinic and calendar year. 1 year
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