Substance AbusePhase 2STaRSNCT01488630
Substance Treatment and HIV Testing and Referral System
A Phase 2 study testing STaRS in people with Substance Abuse, run by Polaris Health Directions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- STaRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substance Treatment Referral System
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.
Read more
Specific Aims of Phase II are:
- Integrate STaRS with the Epic electronic health record used in the Cooper Health System in Camden, N.J.
- 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.
- 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 3,500 adult patients treated during treatment as usual (the time before STaRS is implemented at CFM) as well as 3,500 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.
Read the 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 patient's condition and circumstances (e.g., 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 (e.g., 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:
- Referral Sub-Study. To determine the impact of STaRS on the rate of referral for substance abuse treatment and HIV screening, 7,000 adult patients' charts will be reviewed (3,500 patients seen prior to STaRs implementation and 3,500 patients seen after STaRS implementation).
- 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.
- 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.
- 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.
- Conditions
- Substance Abuse
- Being tested
- STaRS
- Keywords
- substance abuse, alcohol, drug, smoking, HIV screening
- Medical subject headings
- Substance-Related Disorders, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: STaRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Completed after 3500 pre-STaRS charts and 3500 STaRS intervention charts are reviewed, over a period of one year
Secondary outcomes (3)
Treatment Initiation
7000 charts will be reviewed, 140 patients who received referrals for substance abuse and/or HIV testing will be enrolled in the treatment initiation study (70 with referrals from pre-STaRS charts and 70 with referrals from STaRS intervention charts.
Measured: 70 pre-STarS patients and 70 STaRS patients are enrolled, over a period of six months
Billing Revenue
A total of 7000 electronic health records will be reviewed for referral rates (3500 pre-STaRS, 3500 STaRS intervention). Charts of patients who received referrals will be further examined to obtain billing information. This will help determine the impact that STaRS has on increasing revenues to the CFM practices.
Measured: 7000 charts reviewed, over a period of one year
Provider Satisfaction
Focus groups will be conducted with healthcare providers who used the STaRS to make referrals. Data collected at focus groups will be used to improve future versions of STaRS.
Measured: Last month of the study, November 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Health Directions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Grant Grissom, PhD, Principal investigator, Polaris Health Directions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488630
- Sponsor's protocol ID
- N44DA-10-5543
- Other IDs
- STaRS
- Acronym
- STaRS
- Status last verified
- Jul 2018
- First submitted
- 1 Dec 2011
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Treatment Referral System
- ClinicalTrials.gov ID
- NCT01488630
- Acronym / sponsor ID
- STaRS / N44DA-10-5543
- Conditions
- Substance Abuse
- Keywords
- substance abuse, alcohol, drug, smoking, HIV screening
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Polaris Health DirectionsIndustry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Integrate STaRS with the Epic electronic health record used in the Cooper Health System in Camden, N.J.
- 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.
- 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 3,500 adult patients treated during treatment as usual (the time before STaRS is implemented at CFM) as well as 3,500 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 patient's condition and circumstances (e.g., 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 (e.g., 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:
- Referral Sub-Study. To determine the impact of STaRS on the rate of referral for substance abuse treatment and HIV screening, 7,000 adult patients' charts will be reviewed (3,500 patients seen prior to STaRs implementation and 3,500 patients seen after STaRS implementation).
- 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.
- 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.
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Chart review only. |
| STaRS | Experimental | Other: STaRSPatients asked to participate in follow-up study to get information on whether they went to referral recommended by their provider through the STaRS system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STaRSThe 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. | Other | STaRS |
Primary outcome
Referral Rates for Substance Abuse Treatment and HIV Testing
Time frame: Completed after 3500 pre-STaRS charts and 3500 STaRS intervention charts are reviewed, over a period of one year
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)
3 secondary outcomes
Treatment Initiation
Time frame: 70 pre-STarS patients and 70 STaRS patients are enrolled, over a period of six months
Billing Revenue
Time frame: 7000 charts reviewed, over a period of one year
Provider Satisfaction
Time frame: Last month of the study, November 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Grissom, PhD principal investigator
Polaris Health Directions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STaRS in people with Substance Abuse, run by Polaris Health Directions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral Rates for Substance Abuse Treatment and HIV Testing (time frame: Completed after 3500 pre-STaRS charts and 3500 STaRS intervention charts are reviewed, over a period of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.