Project Summary
PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project and others.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Suicide is one of the leading causes of death among teens in the United States. After a suicidal event, such as serious thoughts about taking their own life or suicide plans or attempts, most teens get inpatient psychiatric care. Inpatient care involves staying overnight or longer in the hospital. However, some patients and their families prefer treatment outside of the hospital. Outpatient crisis intervention clinics, or OCICs, offer intensive mental health care without the need for a hospital stay.
In this study, the research team is comparing inpatient psychiatric care to OCICs for treating teens after a suicidal event. The team is looking to see how well each treatment setting reduces the risk of suicidal events.
Who can this research help?
Results may help doctors, teens, and families considering psychiatric care settings for treatment after a suicidal event.
What is the research team doing?
The study includes 1,000 teens who had a suicidal event. The research team is enrolling teens from four emergency departments, or EDs. The team is dividing the teens into two groups that are similar in terms of age, gender, and other factors. Then, the team is assigning the groups by chance to either receive inpatient or OCIC treatment.
With inpatient treatment, teens receive mental health care in the hospital. Clinicians manage their daily therapy and medicines. With OCIC, teens have crisis intervention therapy appointments outside the hospital. Therapy begins within three days of the teen’s visit to the ED and lasts for one to six weeks.
The research team is looking at health records and forms the patients complete to see if teens have another suicidal event in the six months after their ED visit and if so, how many. Every other week during these six months, teens and their guardians also complete surveys to identify suicidal thoughts and behaviors and rate life satisfaction. Two weeks after teens begin treatment, the team is asking teens how satisfied they are with their treatment. The team also wants to know whether details like age or having insurance can help identify which teens may be at risk of not going to treatment.
Teens and parents, psychiatrists, nurses, social workers, and people who specialize in providing community mental health care are helping to plan and conduct the study.
Research methods at a glance
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 1,000 teens ages 12–18 who visit an ED with suicidality and who require a high level of care (OCICs or inpatient psychiatric care) |
Interventions/ Comparators |
|
Outcomes |
Primary: first recurrence of a suicidal event, number of suicidal events Secondary: treatment satisfaction, satisfaction with life, relationship between demographics and no-show risk |
Timeframe | 6-month follow-up for primary outcome |
COVID-19-Related Study
Comparing Approaches to Treat Teens with Suicidal Thoughts during the COVID-19 Pandemic -- The PreSTART Study
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
Suicide is a leading cause of death for youth in the United States. Mental health needs are especially high due to the COVID-19 pandemic. During the pandemic, use of telehealth for treating mental health issues increased. Telehealth is a way to provide care to patients remotely using phone or video.
In this study, the research team wanted to learn how well telehealth worked for youth who went to emergency rooms, or ERs, with suicidal thoughts. The team compared telehealth with two in-person ways of providing care:
- Telehealth. Patients received remote care using phone or video.
- In-person, outpatient care. Patients received care through individual or group therapy at a clinic or other setting.
- Inpatient care. Patients stayed in a mental health center and had one-on-one therapy.
In the ER, doctors first checked youth’s symptoms and health history. Then they assigned youth to receive care in one of the three ways. All treatment included crisis care. The length of treatment differed based on youth’s needs and type of care.
What were the results?
Youth in the three groups didn’t differ in:
- Amount of time between suicide attempts
- Thinking about and planning suicide
- Number of suicide attempts
- Number of ER visits or hospital stays for suicidal thoughts or attempts
- How satisfied youth were with their life
- How satisfied youth were with their care
- How often youth had strong emotions, such as anger and fear, due to the pandemic
Who was in the study?
The study included 249 youth ages 12–18 with suicidal thoughts and 249 legal guardians. Youth presented for care in the ER at one of four hospitals in Ohio, Texas, and New York. Of youth, 66 percent were White, 13 percent were Black, 12 percent were another race, and 8 percent were mixed race. The average age was 15, and 63 percent were female. Also, 46 percent identified as gay, lesbian, bisexual, pansexual, or a sexual orientation other than straight.
What did the research team do?
For youth in the study, the research team reviewed health records each week for new suicide-related visits to the ER, hospital stays, and suicide attempts. Youth and their legal guardians completed online surveys every two weeks for up to six months. Surveys asked about suicide attempts, suicidal thoughts, and how satisfied they were with life and their care. Twice during the same six months, they answered questions about how often they had strong emotions, such as anger and fear, due to the pandemic.
Adults who experienced suicidality during their youth, caregivers of youth who had suicidal thoughts, mental health and other clinicians, and community advocates gave input during the study.
What were the limits of the study?
Doctors decided the type of care that the youth received based on the severity of their symptoms. The differences among youth receiving different types of care may have affected the results.
How can people use the results?
Mental health providers can use these results when considering telehealth for youth with suicidal thoughts, especially when barriers exist for getting in-person care.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
Suicide is a leading cause of death among adolescents in the United States. Mental health needs are especially high due to the COVID-19 pandemic. Before the pandemic, telehealth was rarely used with adolescents with suicidality. Use of telehealth to treat mental health issues increased during the pandemic.
Objective
(1) To compare the safety and effectiveness of and satisfaction with telehealth versus in-person outpatient or inpatient treatment to treat adolescents with suicidal thoughts; (2) To explore pandemic-related experience with and management of strong feelings such as anger and fear
Study Design
Design Element | Description |
---|---|
Design | Observational, non-randomized study with three arms |
Population | 249 adolescents ages 12–18 with suicidal thoughts who were assigned to treatment after ED evaluation at 1 of 4 hospitals in Ohio, Texas, and New York, and 249 legal guardians |
Outcomes |
Primary: recurrence of suicidal events (ED visits, hospitalizations, suicide attempts) and severity of suicidal ideation Secondary: life satisfaction, treatment satisfaction, pandemic-related experience with and management of strong feelings such as anger and fear |
Data Collection Timeframe | October 2020–November 2021 |
This non-randomized observational study compared the effectiveness of telehealth versus outpatient or inpatient treatment on improving outcomes among adolescents with suicidal thoughts.
Clinicians evaluated adolescents who presented to the emergency department (ED) for suicidal ideation and referred them to one of three treatments:
- Telehealth crisis intervention services. Patients received remote care using phone or video.
- In-person outpatient crisis intervention clinics. Patients received care through individual or group therapy at a clinic or other setting.
- Inpatient treatment. Patients were admitted to an inpatient psychiatry unit and received individual therapy.
Treatment was site-specific and varied in duration, but all treatment included crisis intervention.
The study included 249 adolescents ages 12–18 with suicidal ideation and their 249 legal guardians. The adolescents received care from one of four hospitals in Ohio, Texas, and New York. Among adolescents, 66% were White, 13% were Black, 12% were another race, and 8% were mixed race. The average age was 15, 63% were female, and 46% identified as gay, lesbian, bisexual, pansexual, or a sexual orientation other than straight.
At baseline and every two weeks for up to six months, adolescents and their legal guardians completed online surveys about adolescents’ time to repeated suicide attempts, severity of ideation, number of attempts, and life satisfaction. After completing treatment, they responded to questions about treatment satisfaction. At three and six months, they also completed surveys to assess the impact of the pandemic on experiencing and managing strong feelings such as anger and fear. Researchers completed weekly medical record reviews to record recurrent suicide events, ED visits, and hospitalizations.
Adults who experienced suicidality during adolescence, legal guardians of youth experiencing suicidality, mental health and other clinicians, and community advocates provided input throughout the study.
Results
Findings for adolescents did not differ significantly across the three treatments in:
- Time to repeated suicide attempts, severity of suicidal ideation, and number of suicide attempts
- Suicide-related ED visits and hospitalizations
- Life satisfaction
- Treatment satisfaction
- Pandemic-related experience with and management of strong feelings such as anger and fear
Limitations
Researchers did not randomize adolescents to a treatment. Differences in the severity of symptoms or other differences among adolescents assigned to the three treatment groups may have affected the results.
Conclusions and Relevance
This study found no differences in safety, effectiveness, or patient satisfaction among the telehealth, in-person outpatient, and inpatient treatment approaches.
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked for clarification on which of the outcomes related to suicidality was the primary outcome and how the researchers controlled for multiple outcomes. The researchers explained that emergency room visit, suicide attempt and hospitalization were all primary outcomes and they used the Bonferroni correction to account for multiple treatment comparisons for each outcome.
- The reviewers found the results difficult to interpret and asked the researchers to provide more clinically relevant information such as the number of each outcome event in the time periods checked. The researchers created tables that provided the mean and standard deviation for each type of event at each time point.
- The reviewers noted that while the interventions were described well, there was no discussion of what would be considered a dose of each intervention, and how the interventions might have differed during the COVID-19 pandemic. The researchers acknowledged that this was an important consideration but was not in the information they collected for the study. They reported on this lack in their study limitations section.
- The reviewers requested more information about potential comorbid conditions in the sample of adolescents which would be important in understanding and interpreting study results. The researchers stated that they made the decision to not record comorbid conditions because that information in medical charts is often misleading because it is based on immediate functioning. However, they did control for unobserved variables in their analyses, which would include comorbid conditions that could affect treatment outcomes.
- The reviewers questioned the researchers’ assertion that the outpatient treatment was a safer option than inpatient treatment and implication that outpatient treatment was a superior option overall. The reviewers pointed out that the study results indicated that all three treatment conditions offered similar outcomes so the data did not support indicating that one type of treatment was better than another. The researchers acknowledged this and revised the report to clarify that outpatient treatment might be considered a safe alternative to inpatient care but not a superior alternative.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by January 2024.