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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
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicidal Ideation, Suicide, Attempted, Distress, Psychological, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. inpatient or emergency service admission for suicidality or suicide attempt
  2. lifetime suicide attempt
  3. referring clinician determined that the patient did not have appropriate outpatient mental health appointment in the next two weeks (other than an NDA)
  4. an NDA is an appropriate disposition plan
  5. consented to all study procedures.

Exclusion Criteria:

  1. under age 18
  2. insufficient English to understand the study procedures and provide informed consent
  3. too psychotic or manic, aggressive, or cognitively impaired such that outpatient therapy was not indicated
  4. patient not stable enough to be discharged home for a minimum of 24 hours prior to study treatment
  5. court-ordered to outpatient treatment
  6. 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

    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
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    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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