NCT01488630

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. 1.Integrate STaRS with the Epic electronic health record used in the Cooper Health System in Camden, N.J.
  2. 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. 3.Evaluate clinician acceptance and impact upon revenue generation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

December 1, 2011

Last Update Submit

July 17, 2018

Conditions

Keywords

substance abusealcoholdrugsmokingHIV screening

Outcome Measures

Primary Outcomes (1)

  • Referral Rates for Substance Abuse Treatment and HIV Testing

    A total of 7000 electronic health records ( referred to as "charts") will be reviewed for referral rates. Those charts include 3500 pre-STaRS charts (treatment as usual arm) and 3500 STaRS charts (intervention arm)

    Completed after 3500 pre-STaRS charts and 3500 STaRS intervention charts are reviewed, over a period of one year

Secondary Outcomes (3)

  • Treatment Initiation

    70 pre-STarS patients and 70 STaRS patients are enrolled, over a period of six months

  • Billing Revenue

    7000 charts reviewed, over a period of one year

  • Provider Satisfaction

    Last month of the study, November 2012

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Chart review only.

STaRS

EXPERIMENTAL

Patients asked to participate in follow-up study to get information on whether they went to referral recommended by their provider through the STaRS system.

Other: STaRS

Interventions

STaRSOTHER

The intervention entails testing an automated substance abuse treatment referral system (STaRS) to be implemented in primary care practices through electronic health record systems to improve 1) referral rates to specialty care providers, 2) patient treatment initiation with the specialty care providers, and 3) revenues to the practices.

STaRS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All English-speaking adult patients (\>= 18 years old) who received a referral for substance abuse treatment or HIV/AIDS screening from Cooper Family Medicine practices during the study period, and who can be reached at a home telephone or have a monthly cell phone plan.

You may not qualify if:

  • Patients \< 18 years old and patients with poor English comprehension, or who do not have reliable telephone access (i.e., no phone access or buys minutes for a "disposable" cell phone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper Family Medicine

Camden, New Jersey, 08102, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersSmoking

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Grant Grissom, PhD

    Polaris Health Directions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2011

First Posted

December 8, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations