- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01190540
Integrated Infectious Disease Capacity-Building Evaluation (IDCAP)
1. prosince 2014 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
72
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Kampala, Uganda
- Infectious Disease Institute, Makerere University
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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.
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Model of Integrated Capacity Building Program
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Reduce Infection, Illness, and Mortality Rates
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Marcia Weaver, PhD, University of Washington
- Vrchní vyšetřovatel: Sarah Naikoba, BMBCh, MPH, Infectious Disease Institute, Makarere University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Weaver M, Krieger J, Castorina J, et. al.
- World Health Organization. Generalized Cost-Effeciveness Analysis: A Guide. Geneva: World Health Organization, 2003. Available online at: http://www.who.int/choice/en/ Accessed on April 14, 2008.
- The Uganda Bureau of Statistics (UBOS), Macro International Inc., and MEASURE Evaluation. 2008. Uganda Child Verbal Autopsy Study 2007. Calverton, Maryland, USA: UBOS, Macro International Inc., and MEASURE Evaluation.
- Weaver MR, Crozier I, Eleku S, Makanga G, Mpanga Sebuyira L, Nyakake J, Thompson M, Willis K. Capacity-building and clinical competence in infectious disease in Uganda: a mixed-design study with pre/post and cluster-randomized trial components. PLoS One. 2012;7(12):e51319. doi: 10.1371/journal.pone.0051319. Epub 2012 Dec 14.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2008
Primární dokončení (Aktuální)
1. srpna 2012
Dokončení studie (Aktuální)
1. srpna 2012
Termíny zápisu do studia
První předloženo
25. srpna 2010
První předloženo, které splnilo kritéria kontroly kvality
25. srpna 2010
První zveřejněno (Odhad)
27. srpna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
3. prosince 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. prosince 2014
Naposledy ověřeno
1. prosince 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 42657-EG
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Training and supervision
-
Children's Hospital Medical Center, CincinnatiDokončenoPorucha pozornosti s hyperaktivitouSpojené státy
-
Trinitas Comprehensive Cancer CenterAptium Oncology Research NetworkNeznámýRakovina prsuSpojené státy
-
Ari Johnson, MDHarvard Medical School (HMS and HSDM); University of California, San Francisco a další spolupracovníciDokončenoVýkon komunitního zdravotnického pracovníka
-
Florida State UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH)Dokončeno
-
University of NebraskaDokončenoPoruchy související s látkami | Poruchy související s alkoholemSpojené státy
-
Pernille Louise KjeldsenUniversity of Aarhus; Innovation Fund Denmark; Brain+ ApS; Eurostars EUREKAZatím nenabírámeMírná kognitivní poruchaDánsko
-
Cambridge Health AllianceNational Institute of General Medical Sciences (NIGMS); Healing Lodge of the...Zápis na pozvánkuPoruchy související s látkami | Duševní zdravíSpojené státy
-
Unity Health TorontoOCAD University; Toronto Public HealthDokončeno
-
Wake Forest UniversityNáborSarkopenieSpojené státy