NCT02001116

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,626

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

November 27, 2013

Last Update Submit

August 24, 2015

Conditions

Keywords

Quality of careHospitalChildrenWHO guideline

Outcome Measures

Primary Outcomes (2)

  • Quality of Care

    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)

    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

    12 months

Secondary Outcomes (1)

  • Outcomes of QoC

    12 months

Study Arms (2)

Pilot Hospitals

EXPERIMENTAL
Other: Quality Improvement intervention

Control Hospitals

NO INTERVENTION

Interventions

1. 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

Pilot Hospitals

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children not included in the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thalas, Chiu and Issik-Kul Regions

Thalas, Chiu, Issik-Kul, Kyrgyzstan

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations