Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06018285
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-08-25
Brief Title:
Stepped Approach to Reducing Risk of Suicide in Primary Care
Sponsor:
Cynthia Fontanella
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Stepped Approach to Reducing Risk of Suicide in Primary Care
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARRS-PC
Brief Summary:
Suicide is the second leading cause of death among young people aged 12-17 years in the United States yet many youth at risk for suicide are not identified or go untreated Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings including primary care The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement QI intervention entitled STARRS-PC Stepped Approach to Reducing Risk of Suicide in Primary Care compared to treatment as usual TAU in reducing the risk of suicidal behavior among youth in the pediatric primary care setting STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics Clinical pathways are tools used by health professionals to guide evidence-informed practice The STARRS-PC pathway consists of three evidence-based suicide clinical care processes risk detection assessment and triage and if needed follow-up transitional care
STARRS-PC is guided by the Practical Robust Implementation and Sustainability Model PRISM which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability
The main questions the study aims to answer are
Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline primary outcome
Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury and improving family satisfaction at 12 months post-baseline secondary outcomes
What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC
STARRS-PC is guided by the Practical Robust Implementation and Sustainability Model PRISM which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability
The main questions the study aims to answer are
Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline primary outcome
Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury and improving family satisfaction at 12 months post-baseline secondary outcomes
What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC
Detailed Description:
This five-year multi-site study consists of the following essential elements 1 recruitment of 2324 adolescents ages 12-17 years inclusive at baseline and their parentguardian 2 initial assessment of youth and parentguardian participants using direct interviews and standardized questionnaires and 3 follow-up assessments of all participants at 3-months 6-months and 1-year post-baseline To achieve the study objectives the project will be conducted in 16 pediatric primary care practices
The study consists of three phases of data collection TAU intervention and sustainability One thousand thirty-three suicidal youth will be enrolled during the TAU phase and 1291 suicidal youth will be enrolled during the intervention phase total number of youth participants 2324 Youth and parent participants enrolled in the study will complete multiple questionnaires at four time points baseline 3-months 6-months and 12-months Medical record reviews of youth participant files will occur throughout the study and be reviewed by research staff The intervention phase is followed by a 6-month sustainability phase during which the participating practices will work on maintaining or further improving upon the anticipated gains made during the intervention phase
Phase 1 TAU
TAU immediately precedes the intervention phase and ranges in length from 6 to 26 months During TAU participants will be treated according to usual and customary care thus establishing each sites baseline rate of suicide risk screening and detection Usual care at each participating practice involves screening for depression and suicide risk with the PHQ-9 This baseline rate will serve as the control for subsequent study phases
Phase 2 Intervention
The intervention phase will range from 11 to 30 months During this phase each site will implement the clinical pathway which includes universal screening for suicide risk using the Ask Suicide-Screening Questions ASQ a four-item questionnaire Those who screen positive will then be evaluated using the Brief Suicide Safety Assessment BSSA The BSSA allows the clinician to assess the level of suicide risk to then choose how to proceed with clinical next steps Clinicians will triage care based on three categories of risk low-risk further evaluation needed and imminent-risk The risk assessment will determine the type of care the individual then receives eg mental health referrals mental health evaluation and safety plan tele-psychiatry crisis intervention consultation send to ED
We will also conduct in-depth qualitative interviews with a purposive sample of providers eg physicians nurses social workers at each of the participating sites Purposive sampling is a way to identify and recruit participants that are especially experienced with or knowledgeable about a phenomenon of interest Provider participants will complete a series of questionnaires at three separate times 1 prior to clinical pathway training 2 after training and 3 6 months after training Provider participants will also be trained on the quality improvement process for implementing the intervention strategy Some provider participants will be asked to complete up to four qualitative interviews that will focus on the implementation process barriers and facilitators to successful implementation of the clinical pathway and lessons learned
Phase 3 Sustainability
The intervention phase is followed by a 6-month sustainability phase during which the site will work on maintaining or further improving upon the anticipated gains made during the intervention phase No participants will be recruited during the sustainability phase and this phase will not be used to evaluate intervention effectiveness
The specific aims include
Aim 1 To implement study and improve through a Plan-Do-Study-Act PDSA cycle the STARRS-PC intervention that includes suicide risk detection assessment and triage and care management based on risk profile PDSA is a systematic way to test a change that is implemented by breaking down the implementation process into specific steps and then evaluating the outcome improving on it and testing again
Aim 2 Test the effectiveness of STARRS-PC compared to TAU on the primary patient outcome suicide attempts secondary patient outcomes suicidal ideation non-suicidal self-injury NSSI and family satisfaction at 12 months post-baseline as well as mediators and moderators through a stepped wedge design
Hypotheses STARRS-PC will significantly reduce the rate of 1 suicide attempts nonfatal and fatal and 2 suicidal ideation NSSI and improve family satisfaction during the 12-month post-baseline follow-up period compared with TAU
Exploratory Aim 2a To examine whether increases in provider knowledge self-efficacy and buy-in regarding suicide risk screening assessment and management will mediate the intervention effect on patient outcomes
Exploratory Aim 2b To examine whether organization readiness and practice integration will moderate effects of intervention on patient outcomes
Aim 3 To identify barriers to and facilitators of implementation and sustainability of an intervention designed to improve suicide risk detection and risk management using qualitative interviews and surveys with clinical stakeholders at each study site
The study consists of three phases of data collection TAU intervention and sustainability One thousand thirty-three suicidal youth will be enrolled during the TAU phase and 1291 suicidal youth will be enrolled during the intervention phase total number of youth participants 2324 Youth and parent participants enrolled in the study will complete multiple questionnaires at four time points baseline 3-months 6-months and 12-months Medical record reviews of youth participant files will occur throughout the study and be reviewed by research staff The intervention phase is followed by a 6-month sustainability phase during which the participating practices will work on maintaining or further improving upon the anticipated gains made during the intervention phase
Phase 1 TAU
TAU immediately precedes the intervention phase and ranges in length from 6 to 26 months During TAU participants will be treated according to usual and customary care thus establishing each sites baseline rate of suicide risk screening and detection Usual care at each participating practice involves screening for depression and suicide risk with the PHQ-9 This baseline rate will serve as the control for subsequent study phases
Phase 2 Intervention
The intervention phase will range from 11 to 30 months During this phase each site will implement the clinical pathway which includes universal screening for suicide risk using the Ask Suicide-Screening Questions ASQ a four-item questionnaire Those who screen positive will then be evaluated using the Brief Suicide Safety Assessment BSSA The BSSA allows the clinician to assess the level of suicide risk to then choose how to proceed with clinical next steps Clinicians will triage care based on three categories of risk low-risk further evaluation needed and imminent-risk The risk assessment will determine the type of care the individual then receives eg mental health referrals mental health evaluation and safety plan tele-psychiatry crisis intervention consultation send to ED
We will also conduct in-depth qualitative interviews with a purposive sample of providers eg physicians nurses social workers at each of the participating sites Purposive sampling is a way to identify and recruit participants that are especially experienced with or knowledgeable about a phenomenon of interest Provider participants will complete a series of questionnaires at three separate times 1 prior to clinical pathway training 2 after training and 3 6 months after training Provider participants will also be trained on the quality improvement process for implementing the intervention strategy Some provider participants will be asked to complete up to four qualitative interviews that will focus on the implementation process barriers and facilitators to successful implementation of the clinical pathway and lessons learned
Phase 3 Sustainability
The intervention phase is followed by a 6-month sustainability phase during which the site will work on maintaining or further improving upon the anticipated gains made during the intervention phase No participants will be recruited during the sustainability phase and this phase will not be used to evaluate intervention effectiveness
The specific aims include
Aim 1 To implement study and improve through a Plan-Do-Study-Act PDSA cycle the STARRS-PC intervention that includes suicide risk detection assessment and triage and care management based on risk profile PDSA is a systematic way to test a change that is implemented by breaking down the implementation process into specific steps and then evaluating the outcome improving on it and testing again
Aim 2 Test the effectiveness of STARRS-PC compared to TAU on the primary patient outcome suicide attempts secondary patient outcomes suicidal ideation non-suicidal self-injury NSSI and family satisfaction at 12 months post-baseline as well as mediators and moderators through a stepped wedge design
Hypotheses STARRS-PC will significantly reduce the rate of 1 suicide attempts nonfatal and fatal and 2 suicidal ideation NSSI and improve family satisfaction during the 12-month post-baseline follow-up period compared with TAU
Exploratory Aim 2a To examine whether increases in provider knowledge self-efficacy and buy-in regarding suicide risk screening assessment and management will mediate the intervention effect on patient outcomes
Exploratory Aim 2b To examine whether organization readiness and practice integration will moderate effects of intervention on patient outcomes
Aim 3 To identify barriers to and facilitators of implementation and sustainability of an intervention designed to improve suicide risk detection and risk management using qualitative interviews and surveys with clinical stakeholders at each study site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P50MH127476 | NIH | None | None |
| 7956 | OTHER_GRANT | NIMH | httpsreporternihgovquickSearch1P50MH127476 |