Integrated Infectious Disease Capacity-Building Evaluation

Capacity Building Clinical Trial

— IDCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190540
• Other study ID #: 42657-EG
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: December 1, 2014
• Start date: November 2008
• Est. completion date: August 2012

Study information

• Verified date: December 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: School of Medicine Research and Ethics Committee, Makerere University Uganda:Uganda National Committee on Science and Technology Uganda:
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Capacity Building
• Communicable Diseases
• Diagnostic Training
• Infection
• Support for Midlevel Health Professionals

Intervention

Behavioral:
• Training and supervision
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.
• Training and Supervision
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.
• Integrated Management of Infectious Disease (IMID)
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.
• Integrated Management of Infectious Disease (IMID)
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.

Locations

Country	Name	City	State
Uganda	Infectious Disease Institute, Makerere University	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Accordia Global Health Foundation, Makerere University

Country where clinical trial is conducted

Uganda, 

References & Publications (3)

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 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Model of Integrated Capacity Building Program	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	Yes
Primary	Competence of individual clinicians	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	No
Primary	Practice of individual clinicians	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)	No
Primary	Clinical performance indicators	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	No
Secondary	Reduce Infection, Illness, and Mortality Rates	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	Yes

External Links

•   Accordia Global Health Foundation
•   IDCAP project on Accordia's website
•   Infectious Disease Institute, University of Makerere