## Protocol Section
### Identification Module
**NCT ID:** NCT00510679

**Brief Title:** Study of Post-Training Supports for Health Workers in Benin

**Official Title:** A Randomized Controlled Trial of Post-Training Supports for Health Workers Trained in the Use of Integrated Management of Childhood Illness Guidelines in Ouémé Department, Benin

#### Organization Study ID Info
**ID:** CDC-NCID-3279
#### Organization
**Class:** FED
**Full Name:** Centers for Disease Control and Prevention
### Status Module
#### Completion Date
**Date:** 2004-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2007-08-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-08-01

**Overall Status:** COMPLETED

#### Start Date
**Date:** 1999-07

**Status Verified Date:** 2007-08

#### Study First Post Date
**Date:** 2007-08-02
**Type:** ESTIMATED
**Study First Submit Date:** 2007-08-01
**Study First Submit QC Date:** 2007-08-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Ministry of Health, Benin

#### Lead Sponsor

**Class:** FED

**Name:** Centers for Disease Control and Prevention

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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).

**Detailed 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.

### Conditions Module

**Conditions:**

- Malaria

- Pneumonia

- Diarrhea

- Measles

- Malnutrition

**Keywords:**

- Benin

- child health

- developing country

- health services research

- health worker performance

- Integrated Management of Childhood Illness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 1577

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Health worker supports (supervision, job aids, incentives)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.

**Time Frame:** 3 years

**Measure:** Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines, or adequate treatment.

**Time Frame:** 3 years

**Measure:** Mean proportion of needed case management tasks that were performed during consultations.

**Time Frame:** 3 years

#### Secondary Outcomes

**Measure:** Proportion of children with pneumonia who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.

**Time Frame:** 3 years

**Measure:** Proportion of children with malaria who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.

**Time Frame:** 3 years

### Eligibility Module

**Eligibility Criteria:** 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).

**Maximum Age:** 59 Months

**Minimum Age:** 1 Week

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Entire department of Oueme and Plateau

**Country:** Benin

**Facility:** All eligible health facilities

**State:** Oueme and Plateau

#### Overall Officials

**Official 1:**

**Affiliation:** Centers for Disease Control and Prevention

**Name:** Rowe K Alexander, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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. doi: 10.1093/ije/dyg063.

**PMID:** 12714553

**Citation:** 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. doi: 10.1093/intqhc/14.6.521. No abstract available.

**PMID:** 12515339

**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. doi: 10.1177/004947550203200317. No abstract available.

**PMID:** 12139161

**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. doi: 10.2105/ajph.91.10.1625.

**PMID:** 11574325

**Citation:** Rowe AK, Onikpo F, Lama M, Deming MS. Evaluating health worker performance in Benin using the simulated client method with real children. Implement Sci. 2012 Oct 8;7:95. doi: 10.1186/1748-5908-7-95.

**PMID:** 23043671

**Citation:** Rowe AK, Onikpo F, Lama M, Deming MS. The rise and fall of supervision in a project designed to strengthen supervision of Integrated Management of Childhood Illness in Benin. Health Policy Plan. 2010 Mar;25(2):125-34. doi: 10.1093/heapol/czp054. Epub 2009 Nov 18.

**PMID:** 19923206

**Citation:** Osterholt DM, Onikpo F, Lama M, Deming MS, Rowe AK. Improving pneumonia case-management in Benin: a randomized trial of a multi-faceted intervention to support health worker adherence to Integrated Management of Childhood Illness guidelines. Hum Resour Health. 2009 Aug 27;7:77. doi: 10.1186/1478-4491-7-77.

**PMID:** 19712484

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: HIGH

- As Found: Malnutrition

- ID: M11280

- Name: Malaria

- Relevance: LOW

- As Found: Unknown

- ID: M7159

- Name: Diarrhea

- Relevance: HIGH

- As Found: Diarrhea

- ID: M11440

- Name: Measles

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T3571

- Name: Malaria

- Relevance: LOW

- As Found: Unknown

- ID: T3653

- Name: Measles

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000044342

- Term: Malnutrition

- ID: D000003967

- Term: Diarrhea

### Misc Info Module

- Version Holder: 2024-05-24
