NCT03869099

Brief Summary

Pneumonia in Pakistan continues to be the leading killer of children under five. Although various national and provincial programs have tried to tackle this but they have not been able to achieve the desired outcomes. Additionally, there has been limited in depth evaluation of the practices of pneumonia management at various levels of the community. The investigators, therefore, aim to establish an understanding of pneumonia case management at three levels of healthcare - community, first level care facility and practitioner level. This will be conducted through observations of pneumonia case managements practices of healthcare providers at these three levels across the country by simulated patients. Observation checklists will be developed incorporating settings and behaviors. Observation sites will be randomly selected with 32 observations made in each province. The results of this study will yield the ground reality of pneumonia case management in Pakistan. Based on the results of this study, strategies can be devised to improve case management within the community with models of regular monitoring and supervision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

November 26, 2018

Last Update Submit

February 17, 2020

Conditions

Keywords

Childhood pneumoniaacute respiratory illnessPakistan

Outcome Measures

Primary Outcomes (1)

  • To assess number of healthcare providers providing standard pneumonia case management to under five children.

    Standard case management practices regarding pediatric pneumonia comprising of components of history taking, examination, diagnosis and treatment across all provinces of Pakistan will be assessed. An observation checklist will be used to collect both qualitative and quantitative data. Quantitative data will be analyzed through descriptive and inferential statistics which will include province-wise reported frequencies of healthcare providers providing standard pneumonia case management to children under five. Whereas; qualitative data will be assessed through thematic analysis.

    13 months

Study Arms (4)

Sindh

Other: Pneumonia Case Management Practices

KPK

Other: Pneumonia Case Management Practices

Punjab

Other: Pneumonia Case Management Practices

Balochistan

Other: Pneumonia Case Management Practices

Interventions

Standard practices of pneumonia case management at three levels of health care; community level, first level care facility and practitioner level, across Pakistan.

BalochistanKPKPunjabSindh

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Two data collectors per province will be recruited to make the observations making a total of 10 data collectors for all the locations. Additionally, one caregiver per observation will be recruited by the data collectors to accompany them. Meaning 160 caregivers will be recruited. This is to avoid inconvenience to the caregiver and their affected under five children. In case, a community is encountered whereby the cases of pneumonia are very few, then the same caregiver will be accompanied for observation of an LHW, BHU and RHC of that locality as these facilities are closely located. If despite this practice, number of observations are not achievable per site than an additional site will be provided to the data collector to visit.

You may qualify if:

  • Caregivers of children under five years of age. These are those individuals who provide direct care to the child. These could either be a mother, father, grandmother or guardian.
  • The child under five under that caregiver's household must have symptoms of pneumonia/severe pneumonia
  • Caregivers consenting to be a part of the study.

You may not qualify if:

  • Caregivers of children under five suffering from co-morbidity with pneumonia.
  • For LHWs:
  • Those who have been practicing as LHWs for more than one year as identified by talking to the community.
  • Those who belong to the catchment area of the selected study sites
  • For BHUs:
  • Functional BHUs with at least one licensed healthcare provider.
  • For RHC:
  • Functional RHCs with at least one licensed healthcare provider.
  • Public Practitioners:
  • Paediatricians working in a government tertiary healthcare facility as a full time employee.
  • In case the facility/location does not have specialist paediatricians, then general physicians working full time within that facility.
  • Private Practitioners:
  • Full time/part time private paediatric practitioners working in either their private clinics or in private hospitals.
  • In case the facility/location does not have specialist paediatricians, then general physicians working within that facility.
  • BHUs or RHCs run by non -licensed healthcare professionals as there are certain locations whereby due to lack of licensed healthcare professional's facility technicians tend to attend to the patients based on their experience.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MNCHRN

Islamabad, Federal, Pakistan

Location

MeSH Terms

Conditions

PneumoniaCommunicable Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Tabish Hazir, MBBS, FRCPCH

    Maternal, Neonatal and Child Health Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

March 11, 2019

Study Start

May 1, 2018

Primary Completion

June 30, 2019

Study Completion

July 30, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations