CLF: Crisis Line Facilitation

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02459587
• Collaborator: (none)
• Enrollment: 307
• Locations: 2
• Arms: 2
• Actual Duration (Months): 44.6
• Patients Per Site: 153.5
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide; Suicide, Attempted; Hospitals, Psychiatric	Behavioral: Crisis Line Facilitation (CLF); Behavioral: Enhanced Usual Care (EUC)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 307 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Facilitating Use of the Veterans Crisis Line in High-Risk Patients
• Actual Study Start Date: Mar 24, 2016
• Actual Primary Completion Date: Oct 7, 2019
• Actual Study Completion Date: Dec 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crisis Line Facilitation (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.
Placebo Comparator: Enhanced Usual Care (EUC) Enhanced Usual Care	Behavioral: 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.).

Outcome Measures

Primary Outcome Measures

1. Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk [1 year]

   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).

Secondary Outcome Measures

1. Number of Suicide Behavior Events Per Days at Risk [1 year]

   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.

2. Outpatient General Mental Health Clinic Visit [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan	United States	48105
2	Battle Creek VA Medical Center, Battle Creek, MI	Battle Creek	Michigan	United States	49037

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Mark A. Ilgen, PhD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: Ann Arbor - Jul 29, 2019
• Study Protocol and Statistical Analysis Plan: Battle Creek - Jul 29, 2019
• Informed Consent Form: Main Study Consent - Jun 9, 2016
• Informed Consent Form: Qualitative Interview Consents - Feb 14, 2019

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02459587
• Other Study ID Numbers: IIR 14-103
• First Posted: Jun 2, 2015
• Last Update Posted: Apr 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Arm/Group Title	Crisis Line Facilitation	Enhanced Usual Care
Arm/Group Description	Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.	Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
Period Title: 3-Month Follow-up Assessment
STARTED	157	150
COMPLETED	125	119
NOT COMPLETED	32	31
Period Title: 3-Month Follow-up Assessment
STARTED	152	141
COMPLETED	128	116
NOT COMPLETED	24	25
Period Title: 3-Month Follow-up Assessment
STARTED	149	138
COMPLETED	127	111
NOT COMPLETED	22	27

Baseline Characteristics

Arm/Group Title	Crisis Line Facilitation	Enhanced Usual Care	Total
Arm/Group Description	Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.	Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.	Total of all reporting groups
Overall Participants	157	150	307
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.2 (12.8)	46.8 (13.5)	47.0 (13.1)
Sex: Female, Male (Count of Participants)
Female	19 12.1%	20 13.3%	39 12.7%
Male	138 87.9%	130 86.7%	268 87.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.3%	1 0.7%	3 1%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	32 20.4%	22 14.7%	54 17.6%
White	112 71.3%	113 75.3%	225 73.3%
More than one race	7 4.5%	9 6%	16 5.2%
Unknown or Not Reported	4 2.5%	5 3.3%	9 2.9%
Region of Enrollment (Count of Participants)
United States	157 100%	150 100%	307 100%
Columbia Suicide Severity Scale (C-SSRS): Most severe suicidal ideation, Lifetime (Count of Participants)
No suicidal ideation	5 3.2%	1 0.7%	6 2%
Wish to be dead / Non-Specific Active Suicidal Thoughts	20 12.7%	15 10%	35 11.4%
Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act	17 10.8%	24 16%	41 13.4%
Active Suicidal Ideation with Some Intent to Act, without Specific Plan	23 14.6%	21 14%	44 14.3%
Active Suicidal Ideation with Specific Plan and Intent	92 58.6%	89 59.3%	181 59%
Columbia Suicide Severity Scale (C-SSRS): Lifetime Suicide Attempts (Count of Participants)
No attempts	46 29.3%	41 27.3%	87 28.3%
One attempt	31 19.7%	37 24.7%	68 22.1%
2 or more attempts	80 51%	72 48%	152 49.5%
Utilization of the Veterans Crisis Line, Lifetime (Count of Participants)
Never contacted VCL	104 66.2%	104 69.3%	208 67.8%
Contacted VCL once	25 15.9%	22 14.7%	47 15.3%
Contacted VCL 2 or more times	28 17.8%	24 16%	52 16.9%

Outcome Measures

1. Primary Outcome

Title	Number of Veterans Crisis Line (VCL) Contact Events Per Days at Risk
Description	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).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Analytical sample consists of participants who completed at least one follow-up.

Arm/Group Title	Crisis Line Facilitation	Enhanced Usual Care
Arm/Group Description	Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis	Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
Measure Participants	141	131
Measure Person-days	50488	44194
Number [VCL Contact Events]	48	35

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Crisis Line Facilitation, Enhanced Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments	Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person. VCL contacts with and without suicide ideation were combined, due to low counts.
Statistical Test of Hypothesis	p-Value	0.33
	Comments	2-tailed P-value above was calculated from type III test.
	Method	Regression, Cox
	Comments	Model was structured to allow multiple events per person. No covariates.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.92
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.222
	Estimation Comments	Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.218 (SEM=0.222)

2. Secondary Outcome

Title	Number of Suicide Behavior Events Per Days at Risk
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Analytical sample consists of participants who completed at least one follow-up.

Arm/Group Title	Crisis Line Facilitation	Enhanced Usual Care
Arm/Group Description	Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.	Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
Measure Participants	141	131
Measure Person-days	50485	44192
Number [Suicide Behavior Events]	67	116

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Crisis Line Facilitation, Enhanced Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments	Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	All tests of significance were 2-tailed. P-value above is type III. No covariates.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.153
	Estimation Comments	Cox Proportional Hazards Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.660 (SEM=0.153)

3. Secondary Outcome

Title	Outpatient General Mental Health Clinic Visit
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Analytical sample consists of participants who completed at least one follow-up.

Arm/Group Title	Crisis Line Facilitation	Enhanced Usual Care
Arm/Group Description	Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.	Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
Measure Participants	141	131
Mean (Standard Deviation) [Mean number of visits]	24.5 (25.2)	21.2 (20.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Crisis Line Facilitation, Enhanced Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments	Two binary variables were derived from Treatment Services Review responses to identify any general mental health service utilization, one binary variable for Baseline and another for any outpatient mental health service utilization at any time point in the 1 year follow-up period. The Baseline variable was included as a main-effects covariate.
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	Regression, Logistic
	Comments	Bivariate logistic, adjusted for (1) if any general outpatient mental heath visits at baseline (0) otherwise
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	1.146
	Confidence Interval	(2-Sided) 95%; 0.604 to 2.176
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Serious adverse events were death and other life-threatening events. Adverse events were suicidal ideation or behaviors, breach of confidentiality, hospitalizations or other interventions resulting from suicidal thoughts, behaviors, or substance use (e.g. overdose, acute intoxication), hospitalizations for medical reasons, accidents or injuries (including non-suicidal self-injury), and discomfort associated with answering difficult questions.
Arm/Group Title	Crisis Line Facilitation		Enhanced Usual Care
Arm/Group Description	Crisis Line Facilitation (CLF) is a single-session intervention which focuses on increasing awareness and motivation to contact the Veterans Crisis Line during a suicidal crisis.		Enhanced Usual Care (EUC) provided educational materials about the Veterans Crisis Line in addition to the standard of care provided on the inpatient hospital unit.
All Cause Mortality
	Crisis Line Facilitation		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/157 (2.5%)		3/150 (2%)
Serious Adverse Events
	Crisis Line Facilitation		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/157 (2.5%)		7/150 (4.7%)
Cardiac disorders
Death by heart attack	0/157 (0%)	0	1/150 (0.7%)	1
Psychiatric disorders
Death by suicide	2/157 (1.3%)	2	2/150 (1.3%)	2
Death by overdose	2/157 (1.3%)	2	0/150 (0%)	0
Hospitalization	0/157 (0%)	0	4/150 (2.7%)	4
Other (Not Including Serious) Adverse Events
	Crisis Line Facilitation		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/157 (58%)		97/150 (64.7%)
Psychiatric disorders
Psychiatric Hospitalization: Suicidal Ideation	42/155 (27.1%)	74	40/150 (26.7%)	74
Residential Treatment	44/157 (28%)	53	33/150 (22%)	38
Suicide Attempt	19/157 (12.1%)	36	20/150 (13.3%)	26
Psychiatric Hospitalization: Acute Substance Use	9/157 (5.7%)	10	6/150 (4%)	9
Psychiatric Hospitalization: General	6/157 (3.8%)	8	12/150 (8%)	15
Surgical and medical procedures
Medical Hospitalization	8/157 (5.1%)	11	18/150 (12%)	23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.