Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt

Suicidal Ideas Clinical Trial

Official title:

Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355848
• Other study ID #: 39417-C
• Secondary ID: T32HS013835_1
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2011
• Last updated: March 6, 2015
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting. 40 participants will be randomized to receive the brief intervention + care as usual or only care as usual. It is hypothesized that the intervention will be acceptable and feasible to both patients and intervention clinicians.

Description:

The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting, and will be addressed with a sample of cases (N = 40) from Harborview. The participants will be randomized into one of two groups: those that receive the intervention and those that do not. All participants will complete a battery of assessments The intervention is based on the theory of teachable moments, wherein timing in proximity to injury and appropriate treatment setting provide a unique opportunity to create patient behavioral change. The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, and safety planning. A guide to delivering the intervention has been completed and may undergo changes throughout the study. Adherence measures will be developed in order to assess the degree to which the clinician accurately provided the brief intervention without including additional therapeutic elements or leaving out elements required in the intervention guide. Best methods for integrating the brief intervention into services provided on medical and surgical units will be determined, as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• at least 15 years of age

• Inpatient on medical/surgical unit

• Admitted following a suicide attempt

• Sufficient English to benefit from psychotherapy in English

• Consents to be a research participant

Exclusion Criteria:

• Lack of sufficient English to participate in psychotherapy in English

• Prisoner/inmate at time of admission

• Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay on medical/surgical unit. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between the PI and the referring care provider, as well as the PI's own clinical assessment of the patient at the outset of the brief intervention.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Suicidal Ideas
• Suicide, Attempted

Intervention

Behavioral:
• Brief Intervention for Suicidality
Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction Questionnaire	The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.	(baseline) Assessment taking place immediately after completion of intervention	No
Secondary	Scale for Suicide Ideation	The Scale for Suicide Ideation will be used to determine the severity of current suicidality in all participants at the one-month follow-up as compared to the baseline assessment.	One month follow-up assessment	Yes