Integrated Infectious Disease Capacity-Building Evaluation

NCT01190540 | Completed

• 1 other identifier: 42657-EG
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Capacity Building; Support for Midlevel Health Professionals; Diagnostic Training

Keywords

On site support services.; mid level health professionals.; cost effectiveness.; infectious disease.; capacity building.

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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)

• 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

Secondary Outcomes (1)

• Reduce Infection, Illness, and Mortality Rates

  3 years

Study Arms (2)

OSS Phase 1

ACTIVE COMPARATOR

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

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

OSS Phase 2

ACTIVE COMPARATOR

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.

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

Interventions

Training and Supervision BEHAVIORAL

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.

OSS Phase 1

Integrated Management of Infectious Disease (IMID) BEHAVIORAL

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.

OSS Phase 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Makerere University: collaborator
• Accordia Global Health Foundation: collaborator

Study Sites (1)

Infectious Disease Institute, Makerere University

Kampala, Uganda

Location

Related Publications (4)

• Weaver M, Krieger J, Castorina J, et. al.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23272097 DERIVED

Related Links

• Accordia Global Health Foundation
• Infectious Disease Institute, University of Makerere

MeSH Terms

Conditions

Communicable Diseases

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• Marcia Weaver, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Sarah Naikoba, BMBCh, MPH

  Infectious Disease Institute, Makarere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: November 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

UG (1)