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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Suicidal Ideation; Suicide, Attempted; Distress, Psychological
• Intervention / Treatment: Behavioral: Treatment as Usual; Behavioral: Collaborative Assessment and Management of Suicidality

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual; Community Mental Health Center Next Day Appointment clinic	Behavioral: Treatment as Usual; 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.
Experimental: Experimental; Collaborative Assessment and Management of Suicidality (CAMS)	Behavioral: Collaborative Assessment and Management of Suicidality; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Twelve months
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)	Twelve months
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)	Twelve months
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)	Twelve months
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)	Twelve months
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)	Through the end of study treatment, an average of 3 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: American Foundation for Suicide Prevention; The Catholic University of America
• Investigators: Principal Investigator: Katherine A Comtois, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Suicide, Attempted; Psychotherapy; Suicidal Ideation; Distress, Psychological
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: STUDY00010396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No