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Telehealth to Improve Prevention of Suicide (TIPS) (TIPS)

Primary Purpose

Suicide Risk

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth in preventing suicide (TIPS)
Modified ED-SAFE
Treatment as Usual (TAU)
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide Risk focused on measuring suicide ideation, suicide attempt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years old
  • Adults presenting to ED who either screen positive on the universal suicide risk screener completed at triage or those who the ED treating team decides should have a mental health evaluation
  • Research sample limited to those who live in Massachusetts

Exclusion Criteria:

  • < 18 years of age
  • Residing outside Massachusetts

Sites / Locations

  • UMass Chan Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

TIPS Alone

TIPS and ED-SAFE

No intervention, Treatment as Usual

Arm Description

The TIPS synchronous telehealth protocol will consist of (a) two-way televideo evaluation with enhanced suicide risk components, performed by a Masters-level evaluator from Community HealthLink, and (b) telephone consultation and, in some cases, televideo evaluation by a psychiatrist for patients the evaluator judges should be admitted. The primary evaluation will gather data form the ED providers, patient, and any other collateral sources available. The core of the evaluation itself will consist of Community HealthLink's existing standard adult emergency mental health evaluation, which is a semi-structured evaluation focused primarily on informing a disposition decision on whether to admit the patient to a psychiatric unit. The evaluators will use this same evaluation to guide the telehealth evaluation.

Half of the ED discharged patients with suicide risk will also be invited to receive post-discharge telephone counseling originally developed by Principal Investigator in a previous study, "Emergency Department Safety Assessment and Follow-up Evaluation" (ED-SAFE). The participant will receive three calls, clustered within three months of the index visit, with some flexibility to continue beyond that if desired. These coaching calls will still follow the original structure and content from ED-SAFE, with modifications guided by study investigators.

No study related intervention, just monitoring of current practices used to provide suicide-related care in the non-intervention EDs.

Outcomes

Primary Outcome Measures

Percentage of Patients Stratified as High/Imminent Risk
The percentage of patients with final stratum of high risk or who are transferred to another hospital for evaluation among all patients with any risk on screener or evaluated by Behavioral Health
Percentage of Patients Admitted to Inpatient Psychiatric Treatment
Percentage of Patients admitted to inpatient psychiatric treatment among all patients with any risk on screener or evaluated by Behavioral Health
Emergency Department Psychiatric Boarding Hours for Admitted Patients
Average time from Behavioral Health evaluation in the Emergency Department to transfer to inpatient psychiatric hospital for admission.

Secondary Outcome Measures

Intervention Targets - Behavioral Health Evaluations
This intervention target measures the total number of Behavioral Health Evaluations completed
Intervention Targets - Suicide Risk Assessments
The intervention target measures the total number of evidence-based suicide risk assessments completed.
Intervention Targets - Observations
The intervention target measures the number of one-on-one observations ordered.
Intervention Targets - Safety Plans (Total Number)
The intervention target measures the number of safety plans created.
Intervention Targets - Safety Plans (Overall Quality)
The intervention target measures the overall level of safety plan quality. The quality of the safety plan is measured using a standardized form known as the SPISA (Safety Plan Intervention Scoring Algorithm). Each line in the safety plan receives a score of 0-2 and then there is a total score that is the summation of the individual lines. Based on the final score, a final quality category will be assigned - Poor, Mediocre, Satisfactory, Good, or Excellent.
Intervention Targets - Behavioral Health Appointments
The intervention target measures the number of scheduled Behavioral Health appointments prior to discharge.
Intervention Targets - Post Visit Contacts
The intervention target measures the number of post-visit contacts the patient had.
Door to Behavioral Health Evaluation Time
Total time from triage to Behavioral Health evaluation
Total Length of Stay
Total time from registration to patient exiting the Emergency Department
Transfer for psychiatric evaluation
The percentage of patients transferred out of Emergency Department to get Behavioral Health evaluation compared to all patients with any risk on screener or deemed to require a Behavioral Health evaluation
Suicide composite outcome
Number of Emergency Department or inpatient visits with an International Classification of Disease (ICD) code or Natural Language Processing (NLP) algorithm indicating suicidal ideation or behavior or death due to intentional self-injury, as coded on death record
In-situ intentional self-injury
Number of intentional self-harm observed during healthcare encounter
Unintentional injury death
Number of deaths due to injuries not from intentional self-injury

Full Information

First Posted
March 9, 2021
Last Updated
October 31, 2022
Sponsor
University of Massachusetts, Worcester
Collaborators
Community HealthLink, Collective Medical, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04800029
Brief Title
Telehealth to Improve Prevention of Suicide (TIPS)
Acronym
TIPS
Official Title
Telehealth to Improve Prevention of Suicide in EDs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Community HealthLink, Collective Medical, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal of RFA-MH-20-226. Notably, the study will surpass this primary requirement, because it will extend understanding of the relative added value of the ED-SAFE post-visit telephone intervention and will create knowledge about key factors related to implementation and sustainment.
Detailed Description
Suicide is one of the most pressing public health problems facing the United States (US), ranking as the 10th leading cause of death, with incidence rates increasing year after year in the recent past. The National Action Alliance for Suicide Prevention (NAASP) has prioritized suicide prevention efforts in emergency departments (EDs) because of their well-established safety-net role in treating patients with suicide risk. However, there are serious problems with accessing timely, high-quality behavioral healthcare in many EDs, leading to unnecessary psychiatric hospitalizations, long waiting times, and substandard suicide-related care. As suggested by RFA-MH-20-226, telemental health service delivery has promise for not only improving timely access to behavioral health specialists, it also holds promise for improving adherence to best practice suicide prevention standards. The study will evaluate whether telehealth can improve behavioral health specialist access and suicide-related care quality using a Type 2 hybrid effectiveness-implementation trial, titled Telehealth to Improve Prevention of Suicide (TIPS) in EDs. The study will involve ED patients with suicide risk from two Intervention EDs that do not currently have on-site behavioral health specialists and two Non-intervention control EDs. The study design will blend a three-phase interrupted time series design with a nested individual level randomized comparative effectiveness trial. Phase 1, Treatment as Usual (TAU), will comprise a historical control for the four EDs. It will use data spanning three years (October 2017 to September 2020) and will include all patients who screened positive on a universally administered, evidence-based screener, or who received a mental health evaluation in the participating EDs, which will allow the study team to establish a stable, representative control sample. Phase 2, Intervention, will involve implementing the TIPS telehealth protocol into routine clinical care for 24 months within the two Intervention EDs. Masters-level behavioral health specialists from an existing mental health center will perform a behavioral health evaluation using synchronous, two-way televideo software and hardware. In addition, for patients with a preliminary decision to be hospitalized, a telepsychiatrist will be consulted, with the goal of reducing hospitalization for those who can be adequately managed in a lower level of care. When needed, the telepsychiatrist will also complete his or her own televideo evaluation of the patient and collaterals. In addition to expanded behavioral health specialist access, the study team will improve the quality of suicide-related care. The study team will not only provide enhanced training for behavioral health specialists on best practice suicide risk assessment, safety planning, and care transition strategies, the study team will leverage fidelity review of recorded televideo evaluations and provide personalized feedback to improve adherence to performance standards. In addition, during Phase 2, a 50% subset of patients who received the TIPS evaluation during their visit and who are discharged from the ED will be randomly assigned to the evidence-based Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) protocol after the visit (TIPS+EDSAFE). This will allow the Investigators to evaluate the added value of contact after the visit to further decrease suicidal behavior compared to the within-visit components alone (i.e., comparative effectiveness). Phase 3, Sustainment, will be the final phase during which the study team will remove grant financial subsidies for clinical services to definitively ascertain self-sustainability of the interventions. The investigators will collect the same system metrics and clinician behaviors on two Non-intervention EDs across the same time periods. These EDs will not implement the study interventions, and their data will help control for confounders, like macro-system or secular trends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Risk
Keywords
suicide ideation, suicide attempt

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three-phase interrupted time series design - Experimental Group (TIPS alone); Experimental (TIPS + ED-SAFE); Active Comparator - No intervention, monitoring of Treatment as Usual (TAU)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIPS Alone
Arm Type
Experimental
Arm Description
The TIPS synchronous telehealth protocol will consist of (a) two-way televideo evaluation with enhanced suicide risk components, performed by a Masters-level evaluator from Community HealthLink, and (b) telephone consultation and, in some cases, televideo evaluation by a psychiatrist for patients the evaluator judges should be admitted. The primary evaluation will gather data form the ED providers, patient, and any other collateral sources available. The core of the evaluation itself will consist of Community HealthLink's existing standard adult emergency mental health evaluation, which is a semi-structured evaluation focused primarily on informing a disposition decision on whether to admit the patient to a psychiatric unit. The evaluators will use this same evaluation to guide the telehealth evaluation.
Arm Title
TIPS and ED-SAFE
Arm Type
Experimental
Arm Description
Half of the ED discharged patients with suicide risk will also be invited to receive post-discharge telephone counseling originally developed by Principal Investigator in a previous study, "Emergency Department Safety Assessment and Follow-up Evaluation" (ED-SAFE). The participant will receive three calls, clustered within three months of the index visit, with some flexibility to continue beyond that if desired. These coaching calls will still follow the original structure and content from ED-SAFE, with modifications guided by study investigators.
Arm Title
No intervention, Treatment as Usual
Arm Type
Active Comparator
Arm Description
No study related intervention, just monitoring of current practices used to provide suicide-related care in the non-intervention EDs.
Intervention Type
Other
Intervention Name(s)
Telehealth in preventing suicide (TIPS)
Intervention Description
The TIPS synchronous telehealth protocol will consist of (a) two-way televideo evaluation with enhanced suicide risk components, performed by a Masters-level evaluator from Community HealthLink, and (b) telephone consultation and, in some cases, televideo evaluation by a psychiatrist for patients the evaluator judges should be admitted. The primary evaluation will gather data form the ED providers, patient, and any other collateral sources available. The core of the evaluation itself will consist of Community HealthLink's existing standard adult emergency mental health evaluation, which is a semi-structured evaluation focused primarily on informing a disposition decision on whether to admit the patient to a psychiatric unit. The evaluators will use this same evaluation to guide the telehealth evaluation.
Intervention Type
Other
Intervention Name(s)
Modified ED-SAFE
Intervention Description
Half of the ED discharged patients with suicide risk will be invited to receive post-discharge telephone counseling originally developed during the "Emergency Department Safety Assessment and Follow-up Evaluation" (ED-SAFE) study. The participant will receive three coaching/counseling calls, clustered within three months of the index visit, with some flexibility to continue beyond that if desired. These coaching calls will still follow the original structure and content from ED-SAFE, with modifications guided by study investigators.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
No study related intervention, just monitoring of current practices used to provide suicide-related care in the non-intervention EDs.
Primary Outcome Measure Information:
Title
Percentage of Patients Stratified as High/Imminent Risk
Description
The percentage of patients with final stratum of high risk or who are transferred to another hospital for evaluation among all patients with any risk on screener or evaluated by Behavioral Health
Time Frame
24 months
Title
Percentage of Patients Admitted to Inpatient Psychiatric Treatment
Description
Percentage of Patients admitted to inpatient psychiatric treatment among all patients with any risk on screener or evaluated by Behavioral Health
Time Frame
24 months
Title
Emergency Department Psychiatric Boarding Hours for Admitted Patients
Description
Average time from Behavioral Health evaluation in the Emergency Department to transfer to inpatient psychiatric hospital for admission.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Intervention Targets - Behavioral Health Evaluations
Description
This intervention target measures the total number of Behavioral Health Evaluations completed
Time Frame
24 months
Title
Intervention Targets - Suicide Risk Assessments
Description
The intervention target measures the total number of evidence-based suicide risk assessments completed.
Time Frame
24 months
Title
Intervention Targets - Observations
Description
The intervention target measures the number of one-on-one observations ordered.
Time Frame
24 months
Title
Intervention Targets - Safety Plans (Total Number)
Description
The intervention target measures the number of safety plans created.
Time Frame
24 months
Title
Intervention Targets - Safety Plans (Overall Quality)
Description
The intervention target measures the overall level of safety plan quality. The quality of the safety plan is measured using a standardized form known as the SPISA (Safety Plan Intervention Scoring Algorithm). Each line in the safety plan receives a score of 0-2 and then there is a total score that is the summation of the individual lines. Based on the final score, a final quality category will be assigned - Poor, Mediocre, Satisfactory, Good, or Excellent.
Time Frame
24 months
Title
Intervention Targets - Behavioral Health Appointments
Description
The intervention target measures the number of scheduled Behavioral Health appointments prior to discharge.
Time Frame
24 months
Title
Intervention Targets - Post Visit Contacts
Description
The intervention target measures the number of post-visit contacts the patient had.
Time Frame
24 months
Title
Door to Behavioral Health Evaluation Time
Description
Total time from triage to Behavioral Health evaluation
Time Frame
24 months
Title
Total Length of Stay
Description
Total time from registration to patient exiting the Emergency Department
Time Frame
24 months
Title
Transfer for psychiatric evaluation
Description
The percentage of patients transferred out of Emergency Department to get Behavioral Health evaluation compared to all patients with any risk on screener or deemed to require a Behavioral Health evaluation
Time Frame
24 months
Title
Suicide composite outcome
Description
Number of Emergency Department or inpatient visits with an International Classification of Disease (ICD) code or Natural Language Processing (NLP) algorithm indicating suicidal ideation or behavior or death due to intentional self-injury, as coded on death record
Time Frame
24 months
Title
In-situ intentional self-injury
Description
Number of intentional self-harm observed during healthcare encounter
Time Frame
24 months
Title
Unintentional injury death
Description
Number of deaths due to injuries not from intentional self-injury
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years old Adults presenting to ED who either screen positive on the universal suicide risk screener completed at triage or those who the ED treating team decides should have a mental health evaluation Research sample limited to those who live in Massachusetts Exclusion Criteria: < 18 years of age Residing outside Massachusetts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edwin Boudreaux, PhD
Phone
508-3343817
Email
Edwin.Boudreaux@umassmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Sarpong, MA
Phone
(508) 334-9867
Email
Sandra.Sarpong@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Boudreaux, PhD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edwin Boudreaux, PhD
Phone
508-334-3817
Email
Edwin.Boudreaux@umassmed.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset will be shared with the NIMH Data Archive
IPD Sharing Time Frame
We will upload our initial data 6 months after the onset of the implementation of the TIPS intervention into practice, with regular additions approximately every 6 months.
IPD Sharing URL
https://nda.nih.gov/

Learn more about this trial

Telehealth to Improve Prevention of Suicide (TIPS)

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