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Completed

NCT Number: NCT04693845

Aftercare Focus Study (AFS): A Clinical Trial to Reduce Short-Term Suicide Risk After Hospitalization

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.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Distress, Psychological Quality of Life Self-Injurious Behavior Suicide Suicide, Attempted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative Assessment and Management of Suicidality

Behavioral

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.

Treatment as Usual

Behavioral

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 outcomes

  1. Suicidal behavior

    Time frame: Twelve months

    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

  2. Suicidal ideation

    Time frame: Twelve months

    Beck Scale for Suicidal Ideation (BSS) (19 item scale scored 0-2 so scores range from 0-38 with higher scores indicating worse ideation)

  3. Suicidal intent

    Time frame: Twelve months

    Beck Suicide Intent Scale (SIS) (17 item scale scored 0-2 so scores range from 0-34 with higher scores indicating stronger suicide intent)

  4. Psychological Distress

    Time frame: Twelve months

    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)

  5. Quality of life and overall functioning

    Time frame: Twelve months

    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)

  6. Treatment Satisfaction

    Time frame: Through the end of study treatment, an average of 3 months

    Client Satisfaction Questionnaire (8 item scale scored 1-4 resulting in a score ranging from 1-32 with higher indicating greater satisfaction with treatment)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • American Foundation for Suicide Prevention
  • The Catholic University of America

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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