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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00510679
Other study ID # CDC-NCID-3279
Secondary ID
Status Completed
Phase N/A
First received August 1, 2007
Last updated August 1, 2007
Start date July 1999
Est. completion date October 2004

Study information

Verified date August 2007
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The objective of this study was to determine the effectiveness and cost-effectiveness of a package of interventions to support health workers in Benin (in West Africa) who had been trained to use Integrated Management of Childhood Illness guidelines (i.e., guidelines intended to improve the treatment of childhood illnesses).


Description:

Integrated Management of Childhood Illness (IMCI) is a child health strategy in developing countries with a goal of improving the treatment of illnesses at first-level health facilities through the use of clinical practice guidelines. The World Health Organization (WHO) recommends implementing the guidelines with an 11-day training course. There is a concern that health workers might not master all aspects of the guidelines and that health worker performance may deteriorate over time. In 1999, Benin (in West Africa) was planning to implement IMCI. In response to concerns about how well health workers would follow IMCI guidelines, interventions were designed to support health workers after IMCI training: 1) regular supervision of health workers; 2) supervision of supervisors; 3) job aids; and 4) non-financial incentives for health workers. These interventions were intended to be used together. The objective of this study was to determine the effectiveness and cost-effectiveness of the package of interventions to support IMCI-trained health workers in Benin.


Recruitment information / eligibility

Status Completed
Enrollment 1577
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 59 Months
Eligibility Inclusion Criteria:

- Inclusion criteria for health facilities were: 1) public and licensed private health facilities providing outpatient services, and 2) the level of care was appropriate for use of Integrated Management of Childhood Illness (IMCI) guidelines.

- Inclusion criteria for consultations were children 1 week - 59 months old seen for any illness during regular working hours (typically 8am-6pm) on weekdays.

Exclusion Criteria:

- Health facilities in which the level of care was not appropriate for use of Integrated Management of Childhood Illness (IMCI) guidelines(i.e., one referral hospital and one sub-specialty hospital).

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Health worker supports (supervision, job aids, incentives)


Locations

Country Name City State
Benin All eligible health facilities Entire department of Oueme and Plateau Oueme and Plateau

Sponsors (2)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention Ministry of Health, Benin

Country where clinical trial is conducted

Benin, 

References & Publications (4)

Rowe AK, Lama M, Onikpo F, Deming MS. Design effects and intraclass correlation coefficients from a health facility cluster survey in Benin. Int J Qual Health Care. 2002 Dec;14(6):521-3. — View Citation

Rowe AK, Lama M, Onikpo F, Deming MS. Health worker perceptions of how being observed influences their practices during consultations with ill children. Trop Doct. 2002 Jul;32(3):166-7. — View Citation

Rowe AK, Onikpo F, Lama M, Cokou F, Deming MS. Management of childhood illness at health facilities in Benin: problems and their causes. Am J Public Health. 2001 Oct;91(10):1625-35. — View Citation

Rowe AK, Onikpo F, Lama M, Deming MS. Risk and protective factors for two types of error in the treatment of children with fever at outpatient health facilities in Benin. Int J Epidemiol. 2003 Apr;32(2):296-303. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines. 3 years
Primary Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines, or adequate treatment. 3 years
Primary Mean proportion of needed case management tasks that were performed during consultations. 3 years
Secondary Proportion of children with pneumonia who received recommended treatment, according to Integrated Management of Childhood Illness guidelines. 3 years
Secondary Proportion of children with malaria who received recommended treatment, according to Integrated Management of Childhood Illness guidelines. 3 years
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