Outpatient vs Inpatient Care for Suicidal Thoughts

(START Trial)

Recruiting at 3 trial locations

Overseen By Beth Kennard, PsyD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Imminent suicide risk, No supervision, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 180 days

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two types of care for teens experiencing suicidal thoughts or behaviors. It compares inpatient psychiatric treatment, where teens stay in the hospital, with outpatient crisis intervention, where they visit a clinic but remain at home. The goal is to determine which approach better supports teens brought to the emergency department for these issues. Teens who arrive at the emergency department with suicidal thoughts and require further care are suitable candidates. The study aims to enroll up to 1,000 participants over five years. As an unphased trial, it offers a unique opportunity to contribute to important research that could enhance care for teens facing similar challenges.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both inpatient psychiatry and outpatient crisis intervention clinics have distinct safety considerations when treating individuals with suicidal thoughts.

For outpatient crisis intervention clinics, studies indicate that these programs effectively assist those with severe needs, including individuals who are actively suicidal. Safety plans developed in these settings help ensure both immediate safety and long-term stability, making them a well-accepted option for many seeking help.

Inpatient psychiatry presents different challenges. While these settings aim to provide intensive support, research shows that the risk of suicide can be higher during and immediately after a hospital stay. Thus, while inpatient care can be essential for some, awareness of potential risks is important.

Both treatment types have their strengths and challenges. Participants must consider these factors when deciding which treatment might be best for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing outpatient crisis intervention clinics with inpatient psychiatry for addressing suicidal thoughts. Unlike traditional inpatient care, which involves staying in a hospital, outpatient crisis intervention allows individuals to receive intensive support while remaining in their community. This approach could offer a more flexible and less disruptive option, potentially reducing the stigma and stress associated with hospitalization. By studying these two approaches, researchers hope to determine which method is more effective in providing timely help and improving outcomes for individuals struggling with suicidal thoughts.

What evidence suggests that this trial's treatments could be effective for suicidal thoughts?

This trial will compare the effectiveness of two treatment options for suicidal thoughts in teenagers: Inpatient Psychiatry and Outpatient Crisis Intervention Clinic. Research has shown that both hospital stays and outpatient crisis clinics can help reduce suicidal thoughts in teenagers. One study found that hospital stays lowered the chance of another suicide attempt for those who had recently tried to harm themselves. Teens also reported feeling less depressed and anxious after their hospital stay. Another study found that over 85% of teens approved for outpatient crisis care completed the program and made positive progress. These findings suggest that both treatment options can effectively support young people dealing with suicidal thoughts. ^{1 6 7 8 9}

Who Is on the Research Team?

Drew Barzman, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 who arrive at the Emergency Department with suicidal thoughts or behaviors and need more care. They must have a guardian present, score 15-52 on the CHRT-SR scale, and be able to consent to the study. Non-English speakers, those unable to read/respond to surveys, lacking constant adult supervision outside of a hospital, or at immediate risk of suicide are excluded.

Inclusion Criteria

I am a teenager who went to the ER for suicidal thoughts and need more intensive care.

I am between 12 and 17 years old.

You recently went to the Emergency Department because you were thinking about hurting yourself or had tried to hurt yourself.

Exclusion Criteria

I am a teenager who needs round-the-clock supervision but cannot get it at home.

I am an adolescent who does not speak English, which is required for this study's surveys.

If you're a teenager and have serious thoughts about hurting yourself or committing suicide, you won't be able to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Outpatient Crisis Intervention Clinic (OCIC) or inpatient psychiatric treatment

180 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Exploratory Analysis

Assess demographics and potential barriers to treatment for the 'no show' group

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Inpatient Psychiatry
• Outpatient Crisis Intervention Clinic

Trial Overview The trial compares two types of care for teens with suicidal thoughts: staying in an inpatient psychiatry unit versus visiting an outpatient crisis intervention clinic. It's quasi-randomized across four sites over five years aiming for up to 1,000 participants.

How Is the Trial Designed?

Group I: Outpatient Crisis Intervention Clinic Active Control 1 Intervention

OCIC is outpatient crisis intervention clinic

Group II: Inpatient Psychiatry Active Control 1 Intervention

Child and adolescent inpatient treatment

Inpatient Psychiatry is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Inpatient Psychiatry for:

• Severe depression
• Suicidal intent or plan
• Manic episodes
• Psychosis
• Substance-use-related disorders

Approved in European Union as Inpatient Psychiatry for:

• Acute psychiatric disorders
• Severe mental health episodes
• Psychotic disorders
• Mood disorders
• Substance-induced psychosis

Approved in Canada as Inpatient Psychiatry for:

• Severe mental illness
• Suicidal behavior
• Psychotic episodes
• Mood disorders
• Substance-use disorders

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A quality improvement strategy using systematic patient feedback (PCOMS) in an inpatient psychiatric facility with 2,247 patients led to significant improvements in treatment outcomes, with effect sizes comparable to randomized clinical trials for depression.

The readmission rates for patients were notably lower than national benchmarks, at 6.1% within 30 days, indicating that focusing on patient-centered care and real-time feedback may help reduce psychiatric readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient feedback as a quality improvement strategy in an acute care, inpatient unit: An investigation of outcome and readmission rates. Reese, RJ., Duncan, BL., Kodet, J., et al.[2019]

The pilot study demonstrated that The Collaborative Assessment and Management of Suicidality (CAMS) is feasible and effective for treating suicidal inpatients, with significant reductions in depression, hopelessness, and suicidal ideation over an average treatment period of 51 days.

With a sample of 20 patients, the intervention showed large treatment effect sizes (Cohen's d > .80), indicating strong potential for CAMS as a structured approach to reduce suicide risk in hospitalized individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative assessment and management of suicidality in an inpatient setting: results of a pilot study. Ellis, TE., Green, KL., Allen, JG., et al.[2021]

In a study of 126 psychiatric patients, those in short-term hospitalization (maximum three months) showed better clinical outcomes, which were largely attributed to the increased use of group therapy in these units.

The findings suggest that the length of hospital stay influences treatment patterns and outcomes, highlighting the need for further research on how these factors affect patient improvement and the importance of follow-up data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of "short" vs "long" psychiatric hospitalization. I. Inpatient results. Rosen, B., Katzoff, A., Carrillo, C., et al.[2019]

In a study of 39 schizophrenic patients, those treated at a day hospital with an intensive therapeutic program showed significantly greater improvement in symptoms such as autism, affective bluntness, and suspiciousness compared to other treatment settings.

Inpatient treatment remains crucial, as it accounted for over half of all psychiatric referrals, but the day hospital model appears to be more effective for specific symptoms in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Follow-up studies of psychotic patients receiving inpatient treatment or alternative forms of psychiatric care]. Konieczyńska, Z., Pietrzykowska, B., Zaborowski, B.[2006]

Involving patients and families in the aftermath of serious adverse events in Dutch mental healthcare is seen as valuable for emotional support and information sharing, but current policies only address their involvement to a limited extent.

Challenges such as privacy concerns and the nature of involuntary admissions complicate this involvement, highlighting the need for tailored approaches rather than a one-size-fits-all strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving Patients and Families in the Analysis of Suicides, Suicide Attempts, and Other Sentinel Events in Mental Healthcare: A Qualitative Study in The Netherlands. Bouwman, R., de Graaff, B., de Beurs, D., et al.[2023]

Patients with suicidal ideation or behavior had a significantly shorter length of hospitalization compared to non-suicidal patients, despite having greater psychiatric issues.

The study suggests that the assumption that treating suicidal patients leads to longer hospital stays is incorrect, indicating the need for appropriate inpatient care for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do suicidal ideation and behaviour influence duration of psychiatric hospitalization? Smith, D., Fisher, L., Goldney, R.[2019]

In a pilot study involving 88 patients with acute suicidal thoughts or behaviors, both the Collaborative Assessment and Management of Suicidality (CAMS) and enhanced treatment as usual (E-TAU) were effective in reducing suicidal ideation and distress, but CAMS showed larger effect sizes and significant improvements in suicidal ideation for treatment completers.

CAMS patients reported a better therapeutic relationship and had a lower likelihood of suicide attempts within 4 weeks after discharge compared to those receiving E-TAU, suggesting that CAMS may be a promising intervention for inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Collaborative Assessment and Management of Suicidality compared to enhanced treatment as usual for inpatients who are suicidal: A randomized controlled trial. Santel, M., Neuner, F., Berg, M., et al.[2023]

The SAFER Mental Health care bundle, designed for both adults (SAFER-MH) and youth (SAFER-YMH), aims to improve discharge processes in inpatient mental health settings by enhancing information sharing and patient involvement, addressing safety concerns expressed by patients.

This study will assess the feasibility and acceptability of the SAFER interventions over a 6-week period using both quantitative and qualitative methods, with the goal of determining if a larger effectiveness trial is viable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a co-designed care bundle to improve patient safety at discharge from adult and adolescent mental health services (SAFER-MH and SAFER-YMH): protocol for a non-randomised feasibility study. Tyler, N., Angelakis, I., Keers, RN., et al.[2023]

A study comparing care in alternative mental health services (like crisis houses) and standard acute wards found no significant difference in the intensity of staff-patient contact, suggesting that both types of services engage patients similarly.

Alternative services offered more psychological care and less physical or pharmacological treatment than standard wards, and all types of care provided were positively linked to patient satisfaction, highlighting the importance of collaborative care in enhancing patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternatives to standard acute in-patient care in England: differences in content of care and staff-patient contact. Lloyd-Evans, B., Johnson, S., Morant, N., et al.[2010]

A national survey mapped 200 adult crisis resolution teams (CRTs) in England, with 184 (92%) participating, revealing a diverse range of crisis care models, including crisis cafes and street triage teams, which have increased since 2016.

Despite the growth of new crisis care models aimed at enhancing choice and flexibility, there is significant variability in service provision across regions, and a lack of established evidence regarding their effectiveness on user experiences and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging models and trends in mental health crisis care in England: a national investigation of crisis care systems. Dalton-Locke, C., Johnson, S., Harju-Seppänen, J., et al.[2021]

The introduction of an emergency hotline for psychiatric admissions significantly reduced the proportion of hospitalizations from 100% to 44% within three months, indicating a more effective management of psychiatric patients.

Patients who were hospitalized after the hotline's implementation experienced a trend towards shorter average lengths of stay (9.32 days compared to 17.35 days), suggesting improved efficiency in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of implementing a psychiatric emergency hotline on the reduction of acute hospitalizations in a Swiss tertiary hospital. Restellini, A., Kherad, O., Kaiser, S.[2023]

Out of 18,701 adults who attempted suicide and were hospitalized, 56% received mental health services, highlighting a significant gap in care for those in need.

Factors such as higher injury severity, having insurance, and a pre-existing psychiatric diagnosis increased the likelihood of receiving mental health services, while being Black, Hispanic, male, younger, or having a positive alcohol screen decreased the odds, indicating disparities in mental health service access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unequal Treatment? Confronting Racial, Ethnic, and Socioeconomic Disparity in Management of Survivors of Violent Suicide Attempt. El-Qawaqzeh, K., Colosimo, C., Bhogadi, SK., et al.[2023]

A systematic review of 364 studies involving over 150,000 participants highlighted that inpatient mental health settings face unique patient safety challenges, such as medication errors and risks associated with self-harm and restraint measures.

The review indicates that patient safety in these settings is significantly under-researched compared to other healthcare areas, suggesting a need for more focused research and policy development to improve safety practices in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in inpatient mental health settings: a systematic review. Thibaut, B., Dewa, LH., Ramtale, SC., et al.[2020]

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Beyond risk: rethinking hospitalization for suicidal individuals Additionally, meta-analytic data indicate that suicide rates remain alarmingly high immediately after discharge, even when the protective effect of ...

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Inpatient Treatment of Suicidality: A Systematic Review ... A range of interventions for treating suicidality in inpatient settings have been evaluated, with mixed results.