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Crisis Line Facilitation (CLF)

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ClinicalTrials.gov Identifier: NCT02459587
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study is a randomized controlled trial (n = 500) 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 will be recruited during an inpatient psychiatric stay for the treatment of a recent suicidal crisis and 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.

Condition or disease Intervention/treatment Phase
Suicide Suicide, Attempted Hospitals, Psychiatric Behavioral: Crisis Line Facilitation (CLF) Not Applicable

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. The proposed study will recruit 500 participants who are currently treated for a suicidal crisis in VHA inpatient psychiatric but have not recently used the Veterans Crisis Line. This study will be 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Facilitating Use of the Veterans Crisis Line in High-Risk Patients
Actual Study Start Date : March 24, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: CLF
Crisis Line Facilitation
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.

No Intervention: EUC
Enhanced Usual Care



Primary Outcome Measures :
  1. Use of the Veterans Crisis Line [ Time Frame: use of the line over 1-year follow-up ]
    The primary data source for use of the Veterans Crisis Line will be participant medical records, collected through chart audits/abstraction. Self-report and interview questions will also assess for use of the Veterans Crisis Line and any other Crisis Line services.


Secondary Outcome Measures :
  1. Service utilization [ Time Frame: change in service utilization over 1-year follow-up ]
    The primary data source for mental health treatment services will be participant medical records, collected through chart audits/abstraction. Additional questions about treatment utilization will be based on modified items from the Treatment Services Review. Information collected on treatment utilization may include whether a session was scheduled/attended, the number of sessions attended, type and location of provider (primary care doc, therapist, etc.), and type of treatment received (therapy vs. medications).

  2. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 1 year ]
    The Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that is mandated for use in medication trials by the Federal Drug Administration and has been uniquely recommended as a standalone measure of change in suicidal thoughts and behavior over time. The investigators will use the C-SSRS to measure suicide attempts and other suicidal behaviors, including "preparatory behavior", within the follow-up period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)58 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.

    • Similar to the investigators' ongoing IIR which recruited from VHA inpatient units, the investigators do not have explicit exclusion criteria related to psychotic or cognitive disorders.
    • Instead of relying on diagnoses, the investigators will make judgments of appropriateness for the trial based on the clinical judgment of the study staff (supplemented with information in the clinical record).
    • It has been the investigators' experience that patients often are unable to provide informed consent early in a psychiatric stay but their status will improve significantly prior to discharge.
    • The investigators attempt to recruit participants during this period of improved stability and will include individuals who meet the above inclusion/exclusion criteria at that time.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459587


Contacts
Contact: Samantha Lindenauer (734) 845-3597 Samantha.Lindenauer@va.gov
Contact: Emily Yeagley, MPH Emily.Yeagley@va.gov

Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Mark A Ilgen, PhD    734-845-5046    mark.ilgen@va.gov   
Contact: Emily Yeagley, MPH       Emily.Yeagley@va.gov   
Sub-Investigator: Amy S Bohnert, PhD MHS BA         
Sub-Investigator: Elizabeth B Pope, PhD         
Sub-Investigator: Jane H. Forman, AB MHS ScD         
Principal Investigator: Mark A. Ilgen, PhD         
Sub-Investigator: Paul N Pfeiffer, MD MS         
Sub-Investigator: Stephen T. Chermack, PhD MA BA         
Battle Creek VA Medical Center, Battle Creek, MI Recruiting
Battle Creek, Michigan, United States, 49037
Contact: Elizabeth B Pope, PhD    269-966-5600 ext 31973    elizabeth.pope2@va.gov   
Contact: Samantha E Lindenauer, MSW    7348453036    samantha.lindenauer@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mark A. Ilgen, PhD VA Ann Arbor Healthcare System, Ann Arbor, MI

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02459587     History of Changes
Other Study ID Numbers: IIR 14-103
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Self-Injurious Behavior
suicide prevention

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms