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

NCT ID: NCT04693845

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2019-11-30

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.

Conditions

Suicidal Ideation; Suicide, Attempted; Distress, Psychological; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment as Usual

Community Mental Health Center Next Day Appointment clinic

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: 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.

Experimental

Collaborative Assessment and Management of Suicidality (CAMS)

Group Type: EXPERIMENTAL

Collaborative Assessment and Management of Suicidality

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of America

OTHER

Sponsor Role: collaborator

American Foundation for Suicide Prevention

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kate Comtois

Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine A Comtois, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Other Identifiers

STUDY00010396

Identifier Type: -

Identifier Source: org_study_id