Quality of Hospital Care for ChildrenPhase 2/3NCT02001116
Improving the Quality of Paediatric Hospital Care in the Kyrgyz Republic
A Phase 2/3 study testing Quality Improvement intervention in people with Quality of Hospital Care for Children, run by WHO Collaborating Centre for Maternal and Child Health, Trieste at 1 site in Kyrgyzstan.
Trial summary
A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO was established, for the implementation of a WHO Project to improve the quality of pediatric care in the referral hospitals. Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Quality of Hospital Care for Children
- What is being tested?
- Quality Improvement intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,626 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 2/3
- 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
- The study will evaluate Quality of Care delivered to children at hospital level. This will be assessed by a direct review of patients' charts, in comparison with pre-defined standard. At the hospital level children's charts will be randomly chosen among children 2 months to 59 months, hospitalized with common diseases, such as acute respiratory diseases, diarrhoea, and fever.
Who cannot join
- Children not included in the above criteria.
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
Thalas, Chiu and Issik-Kul Regions
Thalas, Chiu, Issik-Kul
About this study
Official title: Improving the Quality of Paediatric Hospital Care in the Kyrgyz Republic: Evaluation of the Impact of the Intervention
A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO was established, for the implementation of a WHO Project to improve the quality of pediatric care in the referral hospitals. The pilot regions selected for this intervention are the three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH project will be implemented at a first stage in a group of 10 pilot hospitals, randomly selected among the existing hospitals in the above cited regions. Pilot Hospitals will be compared to "control hospitals", which are the hospitals in the region not receiving the intervention, using a pre-defined set of indicators of quality of care. The results of the present evaluation on the pilot hospitals will provide data that will inform the MOH on how better to scale up this project at a national scale.
- Conditions
- Quality of Hospital Care for Children
- Being tested
- Quality Improvement intervention
- Keywords
- Quality of care, Hospital, Children, WHO guideline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement interventionOther
- Training for local trainers and medical staff on the National Adaptation of the WHO guidelines "Pocket Book of Hospital Care for Children".
- Regular supporting supervision and monitoring at hospital level aimed at a sustainable improvement of the quality of the paediatric hospital care
| Study group | Role | What they receive |
|---|---|---|
| Pilot Hospitals | Experimental | Not described Receives: Other: Quality Improvement intervention |
| Control Hospitals | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Care
Quality of Care will be measured using 10 pre-defined indicators
- Inappropriate hospitalisation (i.e. versus WHO standards)
- Increased risk of iatrogenic adverse effects (i.e unnecessary poly-therapy, compared to WHO standards)
- Unnecessary pain (i.e. unnecessary injections or other invasive procedures, as compared to WHO standards)
- Incorrect Diagnosis (i.e. versus WHO standards)
- Incorrect Treatment (i.e. versus WHO standards)
- Inconsistency between diagnosis and treatment (i.e. versus WHO standards)
- Inadequate Monitoring: (i.e. versus WHO standards)
- Lack of nutritional evaluation (i.e. versus WHO standards)
- Incorrect use of IV fluids (i.e. versus WHO standards)
Measured: 12 months
Primary outcome
Children with concomitant presence of all the following three indicators of case management: 1) unnecessary hospitalization; 2) increased risk of iatrogenic adverse effects; 3) unnecessary painful procedures
Measured: 12 months
Secondary outcomes (1)
Outcomes of QoC
Summary scores according to the WHO Quality Asessment Tool
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Hospital Care for ChildrenStudies 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,626 participants (actual)
Sponsor and investigators
- Lead sponsor
- WHO Collaborating Centre for Maternal and Child Health, Trieste
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Scientific Center of Children RAMS, Post Graduate Institute of Medical Education and Research, Chandigarh
- Responsible party
- Principal investigator, Marzia Lazzerini, WHO Collaborating Centre for Maternal and Child Health, Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001116
- Sponsor's protocol ID
- WHOCCT-001
- Status last verified
- Aug 2015
- First submitted
- 27 Nov 2013
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Paediatric Hospital Care in the Kyrgyz Republic: Evaluation of the Impact of the Intervention
- ClinicalTrials.gov ID
- NCT02001116
- Acronym / sponsor ID
- WHOCCT-001
- Conditions
- Quality of Hospital Care for Children
- Keywords
- Quality of care, Hospital, Children, WHO guideline
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,626 participants (actual)
- Lead sponsor
- WHO Collaborating Centre for Maternal and Child Health, TriesteUniversity, hospital or other
- Collaborators
- World Health Organization, Scientific Center of Children RAMS, Post Graduate Institute of Medical Education and Research, Chandigarh
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Dec 2013 (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 cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO was established, for the implementation of a WHO Project to improve the quality of pediatric care in the referral hospitals. The pilot regions selected for this intervention are the three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH project will be implemented at a first stage in a group of 10 pilot hospitals, randomly selected among the existing hospitals in the above cited regions. Pilot Hospitals will be compared to "control hospitals", which are the hospitals in the region not receiving the intervention, using a pre-defined set of indicators of quality of care. The results of the present evaluation on the pilot hospitals will provide data that will inform the MOH on how better to scale up this project at a national scale.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Hospitals | Experimental | Other: Quality Improvement intervention |
| Control Hospitals | No intervention | – |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study will evaluate Quality of Care delivered to children at hospital level. This will be assessed by a direct review of patients' charts, in comparison with pre-defined standard. At the hospital level children's charts will be randomly chosen among children 2 months to 59 months, hospitalized with common diseases, such as acute respiratory diseases, diarrhoea, and fever.
Key exclusion criteria (1 listed)
- Children not included in the above criteria.
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 |
|---|---|---|
| Quality Improvement intervention1. Training for local trainers and medical staff on the National Adaptation of the WHO guidelines "Pocket Book of Hospital Care for Children". 2. Regular supporting supervision and monitoring at hospital level aimed at a sustainable improvement of the quality of the paediatric hospital care | Other | Pilot Hospitals |
Primary outcome
Quality of Care
Time frame: 12 months
Quality of Care will be measured using 10 pre-defined indicators 1. Inappropriate hospitalisation (i.e. versus WHO standards) 2. Increased risk of iatrogenic adverse effects (i.e unnecessary poly-therapy, compared to WHO standards) 3. Unnecessary pain (i.e. unnecessary injections or other invasive procedures, as compared to WHO standards) 4. Incorrect Diagnosis (i.e. versus WHO standards) 5. Incorrect Treatment (i.e. versus WHO standards) 6. Inconsistency between diagnosis and treatment (i.e. versus WHO standards) 7. Inadequate Monitoring: (i.e. versus WHO standards) 8. Lack of nutritional evaluation (i.e. versus WHO standards) 9. Incorrect use of IV fluids (i.e. versus WHO standards)
Primary outcome
Time frame: 12 months
Children with concomitant presence of all the following three indicators of case management: 1) unnecessary hospitalization; 2) increased risk of iatrogenic adverse effects; 3) unnecessary painful procedures
1 secondary outcome
Outcomes of QoC
Time frame: 12 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 25 Aug 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Quality Improvement intervention in people with Quality of Hospital Care for Children, run by WHO Collaborating Centre for Maternal and Child Health, Trieste at 1 site in Kyrgyzstan.
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 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 25 Aug 2015. 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 Kyrgyzstan. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Care (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2015.