Crisis Line Facilitation

Suicide Clinical Trial

— CLF  

Official title:

Facilitating Use of the Veterans Crisis Line in High-Risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459587
• Other study ID #: IIR 14-103
• Status: Completed
• Phase: N/A
• Start date: March 24, 2016
• Est. completion date: December 11, 2019

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled trial (n = 301) of a new single-session intervention, called Crisis Line Facilitation (CLF), compared to an enhanced usual care condition on utilization of the Veterans Crisis Line and other mental health services as well as suicide attempt(s). All participants were recruited during an inpatient psychiatric stay for the treatment of a recent suicidal crisis and will be re-assessed at 3-, 6- and 12-months post baseline. If successful, the proposed study will provide key data on the potential efficacy of a brief tool to improve the utilization of an existing resource, the Veterans Crisis Line, to reduce suicidal behaviors in VHA patients.

Description:

Veterans Health Administration (VHA) patients are at a significantly elevated risk for fatal and non-fatal suicide attempts and identifying strategies to reduce the risk of suicidal behavior among members of the military and Veterans is a high national priority. The VHA has invested extensively in suicide prevention and, as part of these efforts; the Veterans Crisis Line was developed as an important resource for Veterans and their families. Utilization of the Veterans Crisis Line has expanded steadily since it first opened and, currently, it receives over 20,000 calls per month. Despite high utilization of the Crisis Line, no data are currently available on whether use of the Veterans Crisis Line reduces an individual's likelihood of a suicide attempt or death and it is not feasible to test the efficacy of the Crisis Line in a randomized controlled trial because it is nationally available to all Veterans and their families. More importantly, the Veterans Crisis Line may not reach those individuals at most acute risk for suicide. The investigators' study team conducted a small survey of Veterans treated for recent suicidal crisis in a VHA inpatient psychiatric unit and found that less than half had ever utilized the Veterans Crisis Line and less than a third had used it within the past year. Consequently, the investigators have developed and gathered pilot data on a brief intervention designed to increase utilization of the Veterans Crisis Line among high risk patients, called Crisis Line Facilitation (CLF). This single-session intervention involves a discussion of the patient's perceived barriers of crisis line use during periods of suicidal crisis. The CLF session ends with the patient calling the Crisis Line with the therapist in the room as a way for Veterans to practice the logistics of making the call and to have direct experiences that may counter any negative beliefs about Veterans Crisis Line use. This study recruited 301 participants who were treated for a suicidal crisis in VHA inpatient psychiatric but had not recently used the Veterans Crisis Line. This study is a randomized controlled trial of the impact of CLF compared to enhanced usual care (EUC) on utilization of the Veterans Crisis Line and other mental health services as well as suicide attempt(s). All participants will be re-assessed at 3-, 6- and 12-months post baseline. Analyses will also examine the extent to which post-baseline Crisis Line use mediates the effect of random assignment to CLF on subsequent suicidal behaviors. Qualitative interviews at the end of the study will help understand barriers and facilitators of future implementation of the CLF intervention. If successful, the proposed study will provide key data on the potential efficacy of a brief intervention to improve the utilization of an existing resource, the Veterans Crisis Line, to reduce suicidal behaviors in VHA patients. Developing a brief and effective approach to encourage use of the Crisis Line has the potential to have a significant and substantial impact on suicide rates within the VHA and could be modified and exported to other populations and settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: December 11, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for screening (Part 1).

• adults age 18 years of age or older receiving care in an inpatient psychiatric unit at either the BC VAMC or AA VAMC;

• mention of a significant suicidal crisis within the intake note;

• medically stable and able to provide informed consent; and

• Mini-Mental State Examination (MMSE) score greater than or equal to 21.

Additional inclusion criteria for the full randomized study (Part 2):

• no reported use of the Veterans Crisis Line within the past 12-months;

• report current suicidal ideation (BSS greater than or equals 5 during the week prior to hospitalization) as reported during the screening interview.

Exclusion Criteria:

Exclusion criteria for screening and full study:

• patients who do not understand English;

• prisoners;

• patients deemed unable to provide informed consent as stated above;

• patients who recently received or are scheduled to receive electroconvulsive therapy (ECT); and

• profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments.

Related Conditions & MeSH terms

• Hospitals, Psychiatric
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Crisis Line Facilitation (CLF)
This single session therapist-delivered intervention addresses Veterans' perceived barriers and facilitators of crisis line use during periods of suicidal crisis. The CLF session culminates with the Veteran calling the Crisis Line with the therapist in the room as a way for the Veteran to practice the logistics of making the call and to have direct experiences that may counter any negative beliefs about Crisis Line use.
• Enhanced Usual Care (EUC)
Those in the EUC condition received the same promotional items and information about the Veterans Crisis Line (VCL) as the CLF condition. Participants were encouraged to seek help via a provider or the VCL if they felt suicidal in the future. Research staff briefly explained key information about the VCL to those in the EUC condition (e.g., the links between the VCL and the VA, the 24/7/365 availability, etc.).

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Battle Creek VA Medical Center, Battle Creek, MI	Battle Creek	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk	The primary data source for information regarding use of the VCL was collected via researcher-administered interview questions during the TimeLine Follow Back assessment. Participants were asked to recall how many times since the last assessment in which they contacted the VCL for any reason. For contacts that occurred, participants were asked to recall the date of these contacts and the type of contact that was made (e.g. phone call, text, or chat).	1 year
Secondary	Number of Suicide Behavior Events Per Days at Risk	The primary data source for suicidal behaviors was the TimeLine Follow Back, a semi-structured researcher-administered interview. Participants were asked to report actual, interrupted, and aborted attempt events that occurred since the last study assessment. Definitions for these events were derived from the Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Behaviors subsection [also administered during the assessment], and dates for these events were entered into the TimeLine Follow Back.	1 year
Secondary	Outpatient General Mental Health Clinic Visit	The primary data source for general mental health treatment service utilization was a modified version of the Treatment Services Review, an researcher-administered structured interview. Participants were asked to report whether or not they had been to a mental health clinic for therapy or medications since the last study assessment.	1 year