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Integrated Infectious Disease Capacity-Building Evaluation (IDCAP)

2014년 12월 1일 업데이트: Marcia Weaver, University of Washington

Cost Effectiveness of Building Capacity of Mid-level Practitioners in Sub-Saharan Africa for the Care and Prevention of HIV, Tuberculosis, Malaria and Related Infectious Diseases

This evaluation aim is to investigate a cost-effective way to build capacity for the care and prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan Africa. Classroom based training continues to be the dominant form of training, despite evidence that suggests that on-site support (OSS) is more beneficial. Definitive evidence that on-site support is the most effective way to deliver the required outputs and related outcomes is still lacking. IDCAP will provide two interventions that integrate training in TB, HIV/AIDS and malaria as well as other infectious diseases, and the effects will be studied: 1) Integrated Management of Infectious Disease (IMID) training program for individual MLP, and 2) On-site support (OSS) for team of health professionals. This study employs a mixed design with pre/post and cluster randomized trial components. Interventions are at the level of the individual participant for IMID and at the level of the site (health facility) for OSS. All participants attend a 3-week course, followed by two 1-week booster courses over a six month period. After the 3-week course, a randomized arm of half the sampled facilities also received OSS every month for 9 months and bi-monthly for 6 additional months.

연구 개요

상세 설명

There are four major components of the evaluation design as described below: 1) Site Assessment, 2) Competence and practice of individual MLP who participate in IDT, 3) Facility cost and performance indicators, and 4) Mortality survey. The site assessment guided the curriculum development and site selection. As shown in Figure 1, it occurred only once in Year 1. The effect of the IMID and OSS on competence of individual MLP will be evaluated with written case scenarios or vignettes. Data on case scenarios will be collected three times: a) before training, b) after the three-week course, and c) after the nine-month program that includes two, one-week booster courses and distance learning. To estimate the effect of IMID, aggregate changes in test score across all 3 time points for both arms will be analyzed jointly. To estimate the effect of OSS, differences in change in test score starting from after the three-week course to the end of the nine-month program will be compared across the 2 arms. The effects on practice of individual trainees will be evaluated with clinical assessments by mobile team faculty during five outpatients visits and five HIV clinic visits by individual MLP. Data on clinical assessments will be collected two times: a) before training, and b) after the nine-month program. Facility performance indicators will be collected on a monthly basis from each site. Sites will be randomly assigned to begin OSS in either Phase 1 or Phase 2 and the facility indicators of these two samples of sites will be compared. The principal investigators of IDCAP are actively considering collecting data on mortality among children under five, but a final decision has not been made. At the request of the acting chairperson of SOMREC, we are including information about this potential activity. Mortality surveys would be conducted before and after the OSS.

연구 유형

중재적

등록 (실제)

72

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

      • Kampala, 우간다
        • Infectious Disease Institute, Makerere University

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

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

Facilities selected for OSS:

  • The health facility had to be a HC IV or comparable facility such as a small general hospital or non-governmental organization clinic
  • It had to be an active ART site or accredited ART site that is scheduled to become active by April 2009
  • No past or current participation in a partnership with the U.S. Department of Defense
  • Has a population of potential patients who are not prisoners
  • Representation from all six administrative regions of Uganda

Exclusion Criteria:

  • NA

MLP selected from the participating facilities for IMID:

Two mid-level practitioners (clinical officers, nurses, or midwives) who are actively engaged in clinical infectious-disease care will be selected for enrollment in IMID

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: OSS Phase 1
Thirty-six sites will receive the On Site Support service (OSS) activities for nine to 15 months; 18 will be randomly assigned to receive the OSS in phase 1
On-Site-Support (OSS) service training will occur monthly for a period of 9 months. This training and supervision will support the proper utilization of newly learned clinical skills.
The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda. After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI. Then the engage in 12 more weeks of distance learning and a final one-week boost course. This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
활성 비교기: OSS Phase 2
Thirty-six sites will receive the OSS activities for nine to 15 months; 18 will be randomly assigned to receive the OSS in phase 2 that will serve as a control group in phase 1 and receive OSS nine months later.
The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda. After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI. Then the engage in 12 more weeks of distance learning and a final one-week boost course. This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
On-Site-Support (OSS) service training will occur monthly for a period of 9 to 15 months. This training and supervision will support the proper utilization of newly learned clinical skills and continuous quality improvement of processes of care. For the control group, the OSS training will occur during phase 2, after a randomly assigned wait list control period.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Model of Integrated Capacity Building Program
기간: monthly over 3 years
The principal output of this evaluation will be a proven model of an integrated capacity-building package for the care and prevention of infectious disease in Africa. The package will include a single curriculum for MLP and a portfolio of on-site support services founded on Accordia Global Health Foundation's considerable experience in training clinicians in North America and Africa.
monthly over 3 years
Competence of individual clinicians
기간: 3 observations at pre/post IMID and final
Competence of individual clinicians will be measured by scores on 12 written case scenarios or vignettes. Three blocks of 4 scenarios each covered different aspects of HIV/AIDS, tuberculosis, malaria, and other infectious diseases and included cases involving children, adults, and pregnant women. Each case scenario addressed 6 principal domains: emergency or danger signs, history and physical examination, laboratory testing, diagnosis or classification of patients' medical problems; initial treatment or referral plan, and evolution of the case over time.
3 observations at pre/post IMID and final
Practice of individual clinicians
기간: Baseline and Endline (9 months)
Clinical assessments will be conducted by mobile team faculty who will observe individual clinicians during five outpatient visits with children under five years and five HIV clinic visits. Clinical practice will be assessed on history, physical examination, review of medical records (HIV clinic only), laboratory investigations ordered, diagnosis, treatment prescribed and patient education.
Baseline and Endline (9 months)
Clinical performance indicators
기간: Monthly beginning 5 months before OSS
54 clinical performance indicators used by the Ministry of Health, the Uganda Malaria Surveillance Program or recommended by international organizations will be used to measure performance in general areas: 1) HIV prevention, 2) HIV care, 3) Antiretroviral therapy, 4) TB/HIV care, 5) Case management of respiratory infections, 6) Case Management of Fever, and 7) Emergency Triage and Treatment.
Monthly beginning 5 months before OSS

2차 결과 측정

결과 측정
측정값 설명
기간
Reduce Infection, Illness, and Mortality Rates
기간: 3 years
The population in the areas surrounding the proposed sites will benefit directly from lower infection, illness and mortality rates. The improved ability of clinic staff to deliver quality prevention and care services will increase access to cost-effective interventions delivered according to national guidelines by 9% to 25% depending on the intervention.
3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Marcia Weaver, PhD, University of Washington
  • 수석 연구원: Sarah Naikoba, BMBCh, MPH, Infectious Disease Institute, Makarere University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2008년 11월 1일

기본 완료 (실제)

2012년 8월 1일

연구 완료 (실제)

2012년 8월 1일

연구 등록 날짜

최초 제출

2010년 8월 25일

QC 기준을 충족하는 최초 제출

2010년 8월 25일

처음 게시됨 (추정)

2010년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 12월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 12월 1일

마지막으로 확인됨

2014년 12월 1일

추가 정보

이 연구와 관련된 용어

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. .

Training and supervision에 대한 임상 시험

구독하다