Aftercare Focus Study (AFS): A Clinical Trial to Reduce Short-Term Suicide Risk After Hospitalization
Primary Purpose
Suicidal Ideation, Suicide, Attempted, Distress, Psychological
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Collaborative Assessment and Management of Suicidality
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicidal Ideation, Suicide, Attempted, Distress, Psychological, Psychotherapy
Eligibility Criteria
Inclusion Criteria:
- inpatient or emergency service admission for suicidality or suicide attempt
- lifetime suicide attempt
- referring clinician determined that the patient did not have appropriate outpatient mental health appointment in the next two weeks (other than an NDA)
- an NDA is an appropriate disposition plan
- consented to all study procedures.
Exclusion Criteria:
- under age 18
- insufficient English to understand the study procedures and provide informed consent
- too psychotic or manic, aggressive, or cognitively impaired such that outpatient therapy was not indicated
- patient not stable enough to be discharged home for a minimum of 24 hours prior to study treatment
- court-ordered to outpatient treatment
- patient lived an impractical distance away
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as Usual
Experimental
Arm Description
Community Mental Health Center Next Day Appointment clinic
Collaborative Assessment and Management of Suicidality (CAMS)
Outcomes
Primary Outcome Measures
Suicidal behavior
Suicidal behavior will be a count of a suicide + all suicide attempts + all acute hospitalizations to prevent suicide. Suicide will be determined by death records; Suicide attempts measured with the Suicide Attempt Self-Injury Count; Hospitalizations measured with the Treatment History Interview-Short Form
Suicidal ideation
Beck Scale for Suicidal Ideation (BSS) (19 item scale scored 0-2 so scores range from 0-38 with higher scores indicating worse ideation)
Suicidal intent
Beck Suicide Intent Scale (SIS) (17 item scale scored 0-2 so scores range from 0-34 with higher scores indicating stronger suicide intent)
Psychological Distress
Outcome Questionnaire-45.2 (45 item scale scored 0-4 with three subscales (symptom distress, interpersonal problems, and social role functioning) and a total score ranging from 0-180 with higher scores indicating worse outcomes)
Quality of life and overall functioning
EQ-5D (5 items scored using an algorithm to create an index value anchored at 1=full health and 0=dead)(Note the measure of this construct was changed from proposed Lehman Quality of Life Interview prior to study recruitment to reduce subject burden)
Treatment Satisfaction
Client Satisfaction Questionnaire (8 item scale scored 1-4 resulting in a score ranging from 1-32 with higher indicating greater satisfaction with treatment)
Secondary Outcome Measures
Full Information
NCT ID
NCT04693845
First Posted
December 30, 2020
Last Updated
December 31, 2020
Sponsor
University of Washington
Collaborators
The Catholic University of America, American Foundation for Suicide Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04693845
Brief Title
Aftercare Focus Study (AFS): A Clinical Trial to Reduce Short-Term Suicide Risk After Hospitalization
Official Title
Aftercare Focus Study (AFS): A Clinical Trial to Reduce Short-Term Suicide Risk After Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
The Catholic University of America, American Foundation for Suicide Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Increasingly, the period after hospital admission is acknowledged as one of extremely high risk for suicidal patients. While it might be hoped that hospitalization would address and resolve suicide risk, a review of international studies shows the risk of suicide is up to 200 times higher among individuals recently discharged from hospitals vs. the general population. In response, some health care systems use an "urgent care" or "next-day appointment" (NDA) clinics for follow-up. NDAs serve as short-term crisis intervention at a specific appointment time and location so patients do not "fall through the cracks" in the care transition. Collaborative Assessment and Management of Suicidality (CAMS) is a potentially effective intervention to reduce short term suicidal risk in this transition from inpatient to outpatient treatment. To this end, this study has the following study aims: (1) Evaluate whether CAMS for suicidal NDA patients results in less suicidal behavior than TAU, (2) Evaluate whether CAMS for suicidal NDA patients results in less suicidal ideation and intent as well as improved mental health markers than TAU, and (3) Evaluate whether CAMS for suicidal NDA patients is more satisfactory to patients than TAU.
Detailed Description
Increasingly, the period after hospital admission is acknowledged as one of extremely high risk for suicidal patients. While it might be hoped that hospitalization would address and resolve suicide risk, a review of international studies shows the risk of suicide is up to 200 times higher among individuals recently discharged from hospitals vs. the general population. In response, some health care systems use an "urgent care" or "next-day appointment" (NDA) clinics for follow-up. NDAs serve as short-term crisis intervention at a specific appointment time and location so patients do not "fall through the cracks" in the care transition. Collaborative Assessment and Management of Suicidality (CAMS) is a promising outpatient treatment framework that merits rigorous study as a potentially effective intervention to reduce short term suicidal risk in the transition from inpatient to outpatient treatment. Pilot data suggest that CAMS decreases suicidal ideation and psychological distress while increasing hope, patient satisfaction, and retention more than NDA treatment as usual (TAU). CAMS in the NDA clinic has the potential to fill three key targets highlighted in the 2012 National Strategy for Suicide Prevention: (1) prevent suicidal behavior, (2) increase clinician confidence and willingness to see suicidal patients, and (3) are sufficiently feasible, trainable, adaptable, and flexible to scale up across health systems. To this end, this study has the following study aims: (1) Evaluate whether CAMS for suicidal NDA patients results in less suicidal behavior than TAU, (2) Evaluate whether CAMS for suicidal NDA patients results in less suicidal ideation and intent as well as improved mental health markers than TAU, and (3) Evaluate whether CAMS for suicidal NDA patients is more satisfactory to patients than TAU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide, Attempted, Distress, Psychological, Quality of Life
Keywords
Suicidal Ideation, Suicide, Attempted, Distress, Psychological, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Outcome assessors were blind to treatment condition
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Community Mental Health Center Next Day Appointment clinic
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Collaborative Assessment and Management of Suicidality (CAMS)
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Assessment and Management of Suicidality
Intervention Description
CAMS is a suicide-focused intervention that stabilizes the suicidal patient and identifies, targets, and treats patient-defined "suicidal drivers"-the problems (e.g., trauma, financial issues, relationship loss) that compel a patient to consider suicide. CAMS is theoretically agnostic, patient-centered, and can be used across different suicidal populations and clinical settings.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Treatment as Usual was based on the staff, policies, and procedures of the community mental health center Next Day Appointment clinic (CMHC) affiliated with our university. Research therapists and the research psychiatrist were hired from the CMHC staff who followed standard CMHC policies and procedures.
Primary Outcome Measure Information:
Title
Suicidal behavior
Description
Suicidal behavior will be a count of a suicide + all suicide attempts + all acute hospitalizations to prevent suicide. Suicide will be determined by death records; Suicide attempts measured with the Suicide Attempt Self-Injury Count; Hospitalizations measured with the Treatment History Interview-Short Form
Time Frame
Twelve months
Title
Suicidal ideation
Description
Beck Scale for Suicidal Ideation (BSS) (19 item scale scored 0-2 so scores range from 0-38 with higher scores indicating worse ideation)
Time Frame
Twelve months
Title
Suicidal intent
Description
Beck Suicide Intent Scale (SIS) (17 item scale scored 0-2 so scores range from 0-34 with higher scores indicating stronger suicide intent)
Time Frame
Twelve months
Title
Psychological Distress
Description
Outcome Questionnaire-45.2 (45 item scale scored 0-4 with three subscales (symptom distress, interpersonal problems, and social role functioning) and a total score ranging from 0-180 with higher scores indicating worse outcomes)
Time Frame
Twelve months
Title
Quality of life and overall functioning
Description
EQ-5D (5 items scored using an algorithm to create an index value anchored at 1=full health and 0=dead)(Note the measure of this construct was changed from proposed Lehman Quality of Life Interview prior to study recruitment to reduce subject burden)
Time Frame
Twelve months
Title
Treatment Satisfaction
Description
Client Satisfaction Questionnaire (8 item scale scored 1-4 resulting in a score ranging from 1-32 with higher indicating greater satisfaction with treatment)
Time Frame
Through the end of study treatment, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
inpatient or emergency service admission for suicidality or suicide attempt
lifetime suicide attempt
referring clinician determined that the patient did not have appropriate outpatient mental health appointment in the next two weeks (other than an NDA)
an NDA is an appropriate disposition plan
consented to all study procedures.
Exclusion Criteria:
under age 18
insufficient English to understand the study procedures and provide informed consent
too psychotic or manic, aggressive, or cognitively impaired such that outpatient therapy was not indicated
patient not stable enough to be discharged home for a minimum of 24 hours prior to study treatment
court-ordered to outpatient treatment
patient lived an impractical distance away
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine A Comtois, PhD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aftercare Focus Study (AFS): A Clinical Trial to Reduce Short-Term Suicide Risk After Hospitalization
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