Integrated Infectious Disease Capacity-Building Evaluation (IDCAP)

University of Washington

Status: Completed

Conditions: Support for Midlevel Health Professionals; Diagnostic Training; Capacity Building

Treatments: Behavioral: Integrated Management of Infectious Disease (IMID); Behavioral: Training and Supervision; Behavioral: Training and supervision

Study type: Interventional

Funder types: Other

Identifiers

NCT01190540

42657-EG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

OSS Phase 1

Active Comparator group

Description:

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

Treatment:

Behavioral: Integrated Management of Infectious Disease (IMID)

Behavioral: Integrated Management of Infectious Disease (IMID)

Behavioral: Training and supervision

OSS Phase 2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Integrated Management of Infectious Disease (IMID)

Behavioral: Integrated Management of Infectious Disease (IMID)

Behavioral: Training and Supervision