MalariaNCT00510679
Study of Post-Training Supports for Health Workers in Benin
A study testing Health worker supports (supervision, job aids, incentives) in people with Malaria and Pneumonia, run by Centers for Disease Control and Prevention at 1 site in Benin.
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… Read more about this study
- Who is it for?
- Ages 1 week to 59 months
- What is being tested?
- Health worker supports (supervision, job aids, incentives)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,577 participants
- Where
- 1 siteBenin
- Study dates
- Jul 1999to Oct 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Benin1 site
All eligible health facilities
Entire Department of Oueme and Plateau, Oueme and Plateau
About this study
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
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).
Read the 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
- Malaria, Pneumonia, Diarrhea, Measles, Malnutrition
- Being tested
- Health worker supports (supervision, job aids, incentives)
- Keywords
- Benin, child health, developing country, health services research, health worker performance, Integrated Management of Childhood Illness
- Medical subject headings
- Malaria, Pneumonia, Diarrhea, Measles, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health worker supports (supervision, job aids, incentives)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.
Measured: 3 years
Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines, or adequate treatment.
Measured: 3 years
Mean proportion of needed case management tasks that were performed during consultations.
Measured: 3 years
Secondary outcomes (2)
Proportion of children with pneumonia who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.
Measured: 3 years
Proportion of children with malaria who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJul 1999
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Health, Benin
- Investigators
- Rowe K Alexander, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510679
- Sponsor's protocol ID
- CDC-NCID-3279
- Status last verified
- Aug 2007
- First submitted
- 1 Aug 2007
- Last updated
- 2 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12714553Rowe 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.
PubMed 12515339Rowe 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.
PubMed 12139161Rowe 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.
PubMed 11574325Rowe 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.
PubMed 23043671Rowe 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.
PubMed 19923206Osterholt 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.
PubMed 19712484
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00510679
- Acronym / sponsor ID
- CDC-NCID-3279
- Conditions
- Malaria, Pneumonia, Diarrhea, Measles, Malnutrition
- Keywords
- Benin, child health, developing country, health services research, health worker performance, Integrated Management of Childhood Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,577 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Health, Benin
- Study start
- Jul 1999
- Study completion
- Oct 2004 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 week to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health worker supports (supervision, job aids, incentives) | Behavioural | – |
Primary outcome
Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.
Time frame: 3 years
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
Mean proportion of needed case management tasks that were performed during consultations.
Time frame: 3 years
2 secondary outcomes
Proportion of children with pneumonia who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.
Time frame: 3 years
Proportion of children with malaria who received recommended treatment, according to Integrated Management of Childhood Illness guidelines.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2007.
- Background: PubMed 12714553Rowe 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.
- Background: PubMed 12515339Rowe 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.
- Background: PubMed 12139161Rowe 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.
- Background: PubMed 11574325Rowe 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.
- Derived from this study: PubMed 23043671Rowe 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.
- Derived from this study: PubMed 19923206Rowe 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.
- Derived from this study: PubMed 19712484Osterholt 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.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rowe K Alexander, MD, MPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health worker supports (supervision, job aids, incentives) in people with Malaria and Pneumonia, run by Centers for Disease Control and Prevention at 1 site in Benin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Benin. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510679, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2007.