Clinical trial NCT02459587: Crisis Line Facilitation
Official title: Facilitating Use of the Veterans Crisis Line in High-Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide, Attempted
Hospitals, Psychiatric
Keywords: Self-Injurious Behavior
suicide prevention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-06-02
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk
timeFrame: 1 year
Secondary outcomes:
measure: Number of Suicide Behavior Events Per Days at Risk
timeFrame: 1 year
measure: Outpatient General Mental Health Clinic Visit
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Battle Creek
country: United States
facility: Battle Creek VA Medical Center, Battle Creek, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Mark A. Ilgen, PhD
role: PRINCIPAL_INVESTIGATOR
References: