PneumoniaNCT02817971
Effect of Enhanced Feedback to Hospitals in an Emerging Clinical Information Network
A study testing Enhanced feedback and Standard feedback in people with Pneumonia, run by KEMRI-Wellcome Trust Collaborative Research Program at 12 sites in Kenya.
Trial summary
A cluster randomised pragmatic trial will be conducted within an emerging clinical information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to an enhanced feedback intervention delivered over a nine-month period and compared to standard feedback. Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Enhanced feedback and Standard feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 12 sitesKenya
- Study dates
- Mar 2016to Dec 2016
- 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 2 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 59 months admitted to participating network hospitals with WHO pneumonia diagnosis eligible for treatment with oral amoxicillin
Who cannot join
- Children aged 2 to 59 months with WHO pneumonia diagnosis and co-morbid illnesses requiring intravenous antibiotic treatment including severe acute malnutrition, bacteraemia, meningitis, or
- children presenting with pneumonia and tuberculosis or cough lasting more than 2 weeks, or severe malaria
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Kenya12 sites
Busia County Hospital
Busia
Embu County Hospital
Embu
Kakamega County Referral Hospital
Kakamega
Vihiga County Hospital
Kakamega
Karatina County Hospital
Karatina
Kerugoya County Hospital
Kerugoya, Kerugoya
Kiambu County Hospital
Kiambu
Kisumu County Hospital
Kisumu
Kitale County Hospital
Kitale
Machakos County Hospital
Machakos
Mama Lucy Kibaki Hospital
Nairobi
Nyeri County Hospital
Nyeri
About this study
Official title: Effect of Enhanced Feedback to Hospitals That Are Part of an Emerging Clinical Information Network on Uptake of Revised Childhood Pneumonia Treatment Policy: A Pragmatic Cluster Randomized Trial Protocol
A cluster randomised pragmatic trial will be conducted within an emerging clinical information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to an enhanced feedback intervention delivered over a nine-month period and compared to standard feedback. The trial to be implemented during a phase of implementing change in guideline recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake of the revised pneumonia treatment recommendations.
Read the detailed description
The international guidelines for the classification and treatment of childhood pneumonia were revised recently and in Kenya the national guidelines changed in February 2016. We designed an enhanced feedback intervention aimed at improving uptake of the revised pneumonia treatment policy within a clinical network of 12 Kenyan county referral hospitals.
Hospitals were randomized to receive either enhanced feedback (n = 6 hospitals) or standard feedback (n = 6 hospitals) delivered over a six-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations. The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure) will be reported as a secondary outcome.
- Conditions
- Pneumonia
- Being tested
- Enhanced feedback, Standard feedback
- Keywords
- feedback, pneumonia, quality of care
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced feedbackBehavioural
Hospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations.
Standard feedbackBehavioural
Hospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced feedback | Experimental | 1. Monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators
2. Two-monthly written feedback on multiple quality of paediatric care indicators
3. Clinical network promoting clinical leadership linked to mentorship and peer to peer support
4. Improved use of health information on service delivery Receives: Behavioral: Enhanced feedback |
| Standard feedback | Active comparator | 1. Two-monthly written feedback on multiple quality of paediatric care indicators
2. Clinical network promoting clinical leadership linked to mentorship and peer to peer support
3. Improved use of health information on service delivery Receives: Behavioral: Standard feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia classification and treatment
The proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations
Measured: 9 months
Secondary outcomes (1)
Antibiotic change
The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- KEMRI-Wellcome Trust Collaborative Research Program
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mike English, MD, Principal investigator, KEMRI-Wellcome Trust Research Priogramme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817971
- Sponsor's protocol ID
- KEMRI_CT_2016\0021
- Status last verified
- Jul 2017
- First submitted
- 27 Jun 2016
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ayieko P, Irimu G, Ogero M, Mwaniki P, Malla L, Julius T, Chepkirui M, Mbevi G, Oliwa J, Agweyu A, Akech S, Were F, English M; Clinical Information Network Authors. Effect of enhancing audit and feedback on uptake of childhood pneumonia treatment policy in hospitals that are part of a clinical network: a cluster randomized trial. Implement Sci. 2019 Mar 4;14(1):20. doi: 10.1186/s13012-019-0868-4.
PubMed 30832678Ayieko P, Irimu G, English M. Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial. Trials. 2017 Sep 7;18(1):416. doi: 10.1186/s13063-017-2152-8.
PubMed 28877729
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enhanced Feedback to Hospitals That Are Part of an Emerging Clinical Information Network on Uptake of Revised Childhood Pneumonia Treatment Policy: A Pragmatic Cluster Randomized Trial Protocol
- ClinicalTrials.gov ID
- NCT02817971
- Acronym / sponsor ID
- KEMRI_CT_2016\0021
- Conditions
- Pneumonia
- Keywords
- feedback, pneumonia, quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- KEMRI-Wellcome Trust Collaborative Research ProgramUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jun 2016 (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.
A cluster randomised pragmatic trial will be conducted within an emerging clinical information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to an enhanced feedback intervention delivered over a nine-month period and compared to standard feedback. The trial to be implemented during a phase of implementing change in guideline recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake of the revised pneumonia treatment recommendations.
Detailed description
The international guidelines for the classification and treatment of childhood pneumonia were revised recently and in Kenya the national guidelines changed in February 2016. We designed an enhanced feedback intervention aimed at improving uptake of the revised pneumonia treatment policy within a clinical network of 12 Kenyan county referral hospitals.
Hospitals were randomized to receive either enhanced feedback (n = 6 hospitals) or standard feedback (n = 6 hospitals) delivered over a six-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations. The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure) will be reported as a secondary outcome.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced feedback | Experimental | Behavioral: Enhanced feedback1. Monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators 2. Two-monthly written feedback on multiple quality of paediatric care indicators 3. Clinical network promoting clinical leadership linked to mentorship and peer to peer support 4. Improved use of health information on service delivery |
| Standard feedback | Active comparator | Behavioral: Standard feedback1. Two-monthly written feedback on multiple quality of paediatric care indicators 2. Clinical network promoting clinical leadership linked to mentorship and peer to peer support 3. Improved use of health information on service delivery |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 2 to 59 months admitted to participating network hospitals with WHO pneumonia diagnosis eligible for treatment with oral amoxicillin
Key exclusion criteria (2 listed)
- Children aged 2 to 59 months with WHO pneumonia diagnosis and co-morbid illnesses requiring intravenous antibiotic treatment including severe acute malnutrition, bacteraemia, meningitis, or
- children presenting with pneumonia and tuberculosis or cough lasting more than 2 weeks, or severe malaria
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 |
|---|---|---|
| Enhanced feedbackHospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations. | Behavioural | Enhanced feedback |
| Standard feedbackHospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children. | Behavioural | Standard feedback |
Primary outcome
Pneumonia classification and treatment
Time frame: 9 months
The proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations
1 secondary outcome
Antibiotic change
Time frame: 9 months
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 24 Jul 2017.
- Derived from this study: PubMed 30832678Ayieko P, Irimu G, Ogero M, Mwaniki P, Malla L, Julius T, Chepkirui M, Mbevi G, Oliwa J, Agweyu A, Akech S, Were F, English M; Clinical Information Network Authors. Effect of enhancing audit and feedback on uptake of childhood pneumonia treatment policy in hospitals that are part of a clinical network: a cluster randomized trial. Implement Sci. 2019 Mar 4;14(1):20. doi: 10.1186/s13012-019-0868-4.
- Derived from this study: PubMed 28877729Ayieko P, Irimu G, English M. Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial. Trials. 2017 Sep 7;18(1):416. doi: 10.1186/s13063-017-2152-8.
- Individual participant dataSharing planned: No
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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.
Mike English, MD principal investigator
KEMRI-Wellcome Trust Research Priogramme
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced feedback and Standard feedback in people with Pneumonia, run by KEMRI-Wellcome Trust Collaborative Research Program at 12 sites in Kenya.
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 1 inclusion and 2 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 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Kenya. 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?
Pneumonia classification and treatment (time frame: 9 months). 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 NCT02817971, which also lists 2 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 24 Jul 2017.