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

Primary Purpose

Suicidal Ideas

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention for Suicidality
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideas focused on measuring Suicide, Brief Intervention, Youth, Acute Medical Setting, Readiness to Change, Suicidality

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Intervention

care as usual

Arm Description

The brief intervention consists of stepped care protocol, including building rapport, functional analysis of suicidal behavior, and crisis planning

Patients randomized to the care as usual arm will not receive the brief intervention.

Outcomes

Primary Outcome Measures

Patient Satisfaction Questionnaire
The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2011
Last Updated
March 6, 2015
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01355848
Brief Title
Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt
Official Title
Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideas
Keywords
Suicide, Brief Intervention, Youth, Acute Medical Setting, Readiness to Change, Suicidality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention
Arm Type
Experimental
Arm Description
The brief intervention consists of stepped care protocol, including building rapport, functional analysis of suicidal behavior, and crisis planning
Arm Title
care as usual
Arm Type
No Intervention
Arm Description
Patients randomized to the care as usual arm will not receive the brief intervention.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention for Suicidality
Intervention Description
Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning
Primary Outcome Measure Information:
Title
Patient Satisfaction Questionnaire
Description
The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.
Time Frame
(baseline) Assessment taking place immediately after completion of intervention
Secondary Outcome Measure Information:
Title
Scale for Suicide Ideation
Description
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.
Time Frame
One month follow-up assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen O'Connor, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived

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

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