Ignite Creation Date:
2024-05-06 @ 12:05 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01488630
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2011-12-01
Brief Title:
Substance Treatment and HIV Testing and Referral System
Sponsor:
Polaris Health Directions
Organization:
Polaris Health Directions
Study Overview
Official Title:
Substance Treatment Referral System
Status:
COMPLETED
Status Verified Date:
2018-07
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:
STaRS
Brief Summary:
The lack of substance screening and referral in healthcare settings is a significant problem with far-reaching consequences including excess morbidity premature mortality and inflated healthcare costs An easy to use time-efficient referral system is needed to address this problem The Substance Treatment Referral Systems STaRS a computer assisted screening and referral system was developed to meet this need
STaRS Phase I demonstrated the feasibility of STaRS to meet this need All aims and evaluation goals of the Phase I study were met or exceeded The purpose of the Phase II research is to demonstrate the clinical utility and commercial viability of STaRS
Specific Aims of Phase II are
1 Integrate STaRS with the Epic electronic health record used in the Cooper Health System in Camden NJ
2 Document STaRS effectiveness in a increasing the number of referrals provided for substance abuse treatment and HIV screening and b increasing the proportion of patients that initiate specialty treatment
3 Evaluate clinician acceptance and impact upon revenue generation
The research will be conducted at Cooper Family Medicine CFM department of Cooper University Hospital in New Jersey We will determine the rate of referrals and treatment initiation for 3500 adult patients treated during treatment as usual the time before STaRS is implemented at CFM as well as 3500 adult patients treated after the introduction of STaRS Patients will be asked about the referral initiation process and CFM healthcare providers will be asked to evaluate the system from a clinical and administrative prospective Finally billing records will be reviewed during the STaRS implementation to determine whether STaRS impacted revenue for the practices
STaRS Phase I demonstrated the feasibility of STaRS to meet this need All aims and evaluation goals of the Phase I study were met or exceeded The purpose of the Phase II research is to demonstrate the clinical utility and commercial viability of STaRS
Specific Aims of Phase II are
1 Integrate STaRS with the Epic electronic health record used in the Cooper Health System in Camden NJ
2 Document STaRS effectiveness in a increasing the number of referrals provided for substance abuse treatment and HIV screening and b increasing the proportion of patients that initiate specialty treatment
3 Evaluate clinician acceptance and impact upon revenue generation
The research will be conducted at Cooper Family Medicine CFM department of Cooper University Hospital in New Jersey We will determine the rate of referrals and treatment initiation for 3500 adult patients treated during treatment as usual the time before STaRS is implemented at CFM as well as 3500 adult patients treated after the introduction of STaRS Patients will be asked about the referral initiation process and CFM healthcare providers will be asked to evaluate the system from a clinical and administrative prospective Finally billing records will be reviewed during the STaRS implementation to determine whether STaRS impacted revenue for the practices
Detailed Description:
STaRS is a computer assisted screening and referral system for problem substance use designed for use in medical settings The primary function of STaRS is to facilitate physician referrals for tobacco alcohol other drugs and HIV screening tailored to the patients condition and circumstances eg zip code and insurance
A prototype of STaRS was developed and found to be feasible in medical settings in Phase I Phase II research will demonstrate clinical utility and commercial viability of the system in a medical setting eg Cooper University Hospital Family Medicine practices Prior to beginning the Phase II research focus groups were conducted to refine changes to the STaRS software These focus groups consisted of healthcare providers from Cooper Family Medicine CFM practices
The Phase II research will be conducted in several parts described in the following sub-studies conducted simultaneously
1 Referral Sub-Study To determine the impact of STaRS on the rate of referral for substance abuse treatment and HIV screening 7000 adult patients charts will be reviewed 3500 patients seen prior to STaRs implementation and 3500 patients seen after STaRS implementation
2 Treatment Initiation Sub-Study To test the effectiveness of STaRS on treatment initiation 140 patients who receive referrals during the STaRS implementation will be telephoned by research staff and invited to participate in this sub-study to document treatment initiation Treatment initiation refers to whether the patient has made contact or scheduled an appointment with the referral provider
3 Billing and Revenue Generation Sub-Study Seven thousand medical records will be reviewed for the referral study described above Patients who were given referrals for substance use and HIV screening will have their billing records reviewed by the Cooper Research Assistant RA The goal is to determine the amount billed for the session in which the referral was made and the amount paid by the insurer or Medicaid Medicare This data will be used to determine the effectiveness of STaRS to increase revenues for the practices
4 Provider Evaluation of STaRS Sub-Study At the conclusion of the study focus groups will be conducted with the CFM healthcare providers The focus groups will have 3 goals Rating the STaRS system on ease of use and clinical utility soliciting suggestions regarding enhancements to STaRS and procedures to implementation and training and identifying any factors that may have influenced the providers to screen or refer patients
A prototype of STaRS was developed and found to be feasible in medical settings in Phase I Phase II research will demonstrate clinical utility and commercial viability of the system in a medical setting eg Cooper University Hospital Family Medicine practices Prior to beginning the Phase II research focus groups were conducted to refine changes to the STaRS software These focus groups consisted of healthcare providers from Cooper Family Medicine CFM practices
The Phase II research will be conducted in several parts described in the following sub-studies conducted simultaneously
1 Referral Sub-Study To determine the impact of STaRS on the rate of referral for substance abuse treatment and HIV screening 7000 adult patients charts will be reviewed 3500 patients seen prior to STaRs implementation and 3500 patients seen after STaRS implementation
2 Treatment Initiation Sub-Study To test the effectiveness of STaRS on treatment initiation 140 patients who receive referrals during the STaRS implementation will be telephoned by research staff and invited to participate in this sub-study to document treatment initiation Treatment initiation refers to whether the patient has made contact or scheduled an appointment with the referral provider
3 Billing and Revenue Generation Sub-Study Seven thousand medical records will be reviewed for the referral study described above Patients who were given referrals for substance use and HIV screening will have their billing records reviewed by the Cooper Research Assistant RA The goal is to determine the amount billed for the session in which the referral was made and the amount paid by the insurer or Medicaid Medicare This data will be used to determine the effectiveness of STaRS to increase revenues for the practices
4 Provider Evaluation of STaRS Sub-Study At the conclusion of the study focus groups will be conducted with the CFM healthcare providers The focus groups will have 3 goals Rating the STaRS system on ease of use and clinical utility soliciting suggestions regarding enhancements to STaRS and procedures to implementation and training and identifying any factors that may have influenced the providers to screen or refer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| STaRS | REGISTRY | STaRS | None |