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Substance Treatment and HIV Testing and Referral System (STaRS)

2018년 7월 17일 업데이트: Polaris Health Directions

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.

Specific Aims of Phase II are:

  1. Integrate STaRS with the Epic electronic health record used in the Cooper Health System in Camden, N.J.
  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 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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:

  1. 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).
  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.

연구 유형

중재적

등록 (실제)

60

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • New Jersey
      • Camden, New Jersey, 미국, 08102
        • Cooper Family Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Treatment as Usual
Chart review only.
실험적: STaRS
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Referral Rates for Substance Abuse Treatment and HIV Testing
기간: 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)
Completed after 3500 pre-STaRS charts and 3500 STaRS intervention charts are reviewed, over a period of one year

2차 결과 측정

결과 측정
측정값 설명
기간
Treatment Initiation
기간: 70 pre-STarS patients and 70 STaRS patients are enrolled, over a period of six months
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.
70 pre-STarS patients and 70 STaRS patients are enrolled, over a period of six months
Billing Revenue
기간: 7000 charts reviewed, over a period of one year
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.
7000 charts reviewed, over a period of one year
Provider Satisfaction
기간: Last month of the study, November 2012
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.
Last month of the study, November 2012

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Grant Grissom, PhD, Polaris Health Directions

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 12월 1일

기본 완료 (실제)

2013년 3월 1일

연구 완료 (실제)

2013년 3월 1일

연구 등록 날짜

최초 제출

2011년 12월 1일

QC 기준을 충족하는 최초 제출

2011년 12월 6일

처음 게시됨 (추정)

2011년 12월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 7월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 17일

마지막으로 확인됨

2018년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • N44DA-10-5543
  • STARS (STaRS)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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