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Trial registered on ANZCTR


Registration number
ACTRN12617000309381
Ethics application status
Approved
Date submitted
11/01/2017
Date registered
27/02/2017
Date last updated
22/03/2021
Date data sharing statement initially provided
21/06/2019
Date results provided
22/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Supportive supervision of Lady Health Workers to improve quality of services for addressing childhood pneumonia and diarrhea prevention and treatment - the nigraan plus trial
Scientific title
Supportive supervision of Lady Health Workers to improve quality of services for addressing childhood pneumonia and diarrhea prevention and treatment - the nigraan plus trial
Secondary ID [1] 290888 0
None
Universal Trial Number (UTN)
Trial acronym
UeN: NP
Linked study record
ACTRN12613001261707

Health condition
Health condition(s) or problem(s) studied:
Childhood diarrhea 301601 0
Childhood pneumonia 301602 0
Condition category
Condition code
Public Health 301308 301308 0 0
Health service research
Infection 301309 301309 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: intervention arm
Rationale
Lady Health Workers (LHWs) have had little impact on increasing coverage of pneumonia and diarrhea treatment interventions. Despite the deployment of over 100,000 LHWs the under-five mortality rate in Pakistan is stagnant. Only 38% children sick with diarrhea receive ORS and a mere 42% with pneumonia receive antibiotics. The main deficiencies of the LHW program are weak LHW knowledge and skills and deficient supervision. There is evidence that increased supervisory competence and supportive supervision improves knowledge, skills and overall performance of junior staff. Therefore identifying strategies to strengthen existing supportive supervision through a stakeholder perception analysis followed by a specific intervention addressing the lack of supportive supervision by Lady Health Supervisors (LHS) can result in expanding coverage and quality of case management of diarrhea and pneumonia in children under five years of age. Therefore, project “NIGRAAN plus” aims to explore an optimum strategy for structured supportive supervision of LHWs and demonstrate how this intervention can or cannot enhance LHW performance for improving health of children under five. Primary aim is to improve the CCM and supervision skills of LHSs for childhood diarrhea and pneumonia and assess trickle-down effect on improvement in LHW CCM performance and community caregiver practices.
Methods and materials:
This is a two year cluster randomized controlled trail. The intervention will be rolled out in three phases. A six month pre-intervention phase will be followed by the active intervention phase of 12 months.
The study will be conducted in District Mirpur Khas, in Sindh with LHS, LHW, primary caregivers of children under five (mothers), implementers and policy makers as study participants.
The study will be implemented in three stages. In the pre-intervention period, formative research will be done to build the optimized supervisory intervention. Focus group discussions (FGDs) and key informant interviews will be conducted with LHWs, LHS, Provincial Coordinator LHW program, District Health Officer, Additional District Commissioner, and decision makers – Secretary/Addl. Secretary Health, and the results will be fed into an evidence-based intervention. Participants will receive a minimal allowance for travel. A sample baseline household survey will be conducted in this phase to study caregiver knowledge and practices about childhood diarrhea and pneumonia. The survey will also assess caregivers’ knowledge, attitudes and perceptions about the LHW program. A baseline assessment of knowledge and skills of all study LHWs and LHSs will also be conducted in the pre-intervention period.
In the next phase, the intervention will be rolled out which consists of training intervention LHSs in community case management (CCM) skills as well as supervision skills. The training will utilize lectures, audiovisual aids, and a training manual formulated by the research team building on Lady Health Worker Program (LHWP) diarrhea and pneumonia CCM curriculum. Two project Co-investigators will conduct the training only to intervention arm LHSs. The training will consist of 22 sessions over three days with each session lasting about an hour. The training will consist of three modules. The first module – the introductory module – will refresh LHSs knowledge and skills for CCM of diarrhea and pneumonia. The sessions in this module will deal with clinical management of childhood diarrhea and pneumonia in the community. These skills include history taking, examining the sick child, and recognizing signs that should prompt treatment and/or referral. Additionally, the in-class training will be complemented by supervised hand-on practice of these skills in a hospital. The second module, called introduction to supervision module, will familiarize LHSs with the roles and qualities of a supervisor, expectations from a supervisor, the distinction between supervision and mentoring, and various types of supervision. The third and final module, called giving structures feedback to LHWs, will deepen LHSs understanding of supportive supervision. In this module LHSs will also be trained in providing structured written feedback to LHWs and providing clinical mentoring to LHWs. Finally, supervision tools to be utilized in the study will be introduced and LHSs will be trained in using them.
During the intervention phase, intervention arm LHSs will provide written feedback to LHWs about the LHW’s CCM performance in real time in the community. A surveillance system with SMS based communication will be set up to improve communication between LHWs and LHSs so that cases are promptly reported and supervision visits can take place timely. Currently, no such system of communication exists between LHWs and LHSs and an LHW reports all her cases to the LHSs in a monthly report. With Nigraan plus’s SMS based surveillance system, LHWs can promptly report cases to the LHS and the LHS can plan a field supervision visit during the next 24 hours. During that visit the LHS will provide mentoring and supervisory feedback (verbal and written) to the LHW in real time in the field during follow up visit to the sick child’s house. By LHW program requirement an LHS must conduct a supervisory visit with each of her LHWs at least once a month.
During the intervention period, periodic knowledge and skill assessments of LHWs and LHSs will be done through structured instruments by trained independent evaluators.
At the end of the intervention period, an endline household survey will be done with caregivers. An assessment of LHS and LHW knowledge and skills assessment will be done.
A final assessment of LHW and LHS knowledge and skills will be done six months after the end of intervention.

The following tools will be introduced to complement the above trainings to address the structural gaps in the existing LHS supervisory tools:
i. Modified Supervisory Checklist: this modified checklist removes ambiguities in the original checklist related to monitoring of LHWs through direct observation.
ii. LHS Feedback Card for Individual LHWs: This innovation addresses the gap identified in FENP: 61 per cent of LHWs received no feedback from their supervisors by making the feedback process specific and clear.

These instruments will be refined and finalized after the pre-intervention formative research. Based on current LHS charter of responsibilities and consultations with the DoH, the additional time required by LHSs to implement these tools is anticipated to be approximately 10 minutes per LHW per month.
In the project report we will report on the training sessions as planned. Regarding intervention fidelity, feedback card distribution, will be tracked through monthly monitoring data which will provide data about provision of feedback to LHWs.
Intervention code [1] 296833 0
Behaviour
Intervention code [2] 297060 0
Treatment: Other
Comparator / control treatment
Control arm LHSs will be given the standard LHW program refresher in pneumonia and diarrhea CCM at the start of the intervention.
LHSs and LHWs in control arm will follow standard LHW program practices during the intervention phase.
All the knowledge and skill assessments will also be carried out on control arm LHWs and LHSs. Control arm LHWs will also be required to report cases of diarrhea and pneumonia to their LHSs.
Control group
Active

Outcomes
Primary outcome [1] 300718 0
Proportion of LHSs and LHWs with correct diarrhea and pneumonia CCM skills (disease classification, treatment, referral) and skill (diagnosis, treatment, referral). (composite outcome).
The outcome will be assessed through field-based skill assessment of LHWs and LHSs using standardized scorecards.
Timepoint [1] 300718 0
Baseline - before intervention onset
Midline - Six months after onset of intervention
Endline - Six months after end of intervention
Primary outcome [2] 300720 0
Percentage of children who receive ORS/RHF for diarrhea.
The outcome will be assessed through baseline and endline household survey.
Timepoint [2] 300720 0
Baseline - before intervention onset
Endline - immediately after end of intervention
Primary outcome [3] 300722 0
Percentage of children who receive antibiotics for pneumonia
The outcome will be assessed through baseline and endline household survey.
Timepoint [3] 300722 0
Baseline - before intervention onset
Endline - immediately after end of intervention
Secondary outcome [1] 330693 0
Case fatality rate of diarrhea and pneumonia in children under-five. (Composite outcome)
The outcome will be assessed through baseline and endline household survey using the household survey questionnaire, which has been adapted from the DHS household survey questionnaire for this project.
Timepoint [1] 330693 0
Baseline - before intervention onset
Endline - immediately after end of intervention
Secondary outcome [2] 330694 0
Percentage of children with severe disease (according to WHO classification: severe and very severe pneumonia and severe dehydration).
The outcome will be assessed through follow up with children through the surveillance system set up for the project using standardized surveillance forms. .
Timepoint [2] 330694 0
Every three months from beginning of intervention till the end of intervention.

Eligibility
Key inclusion criteria
Lady health supervisors (LHSs) fulfilling the following criteria will be involved in project:
1. LHS who is performing duties as part of LHW program within geographical boundaries of the district
2. LHS whose employment terms are permanent
3. LHS who conducts ‘field monitoring visits’ and reports them to the district level authorities.

Inclusion criteria for Lady Health Workers (LHWs) in project are as follows:
1. LHW who is performing duties as part of LHW program within geographical boundaries of the district
2. LHW who provides services to the households as per LHW program guidelines and reports the relevant data to the respective supervisor/LHS
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
LHWs and LHSs who are not actively performing duties in their designated areas in the district.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation to intervention/control arm clusters will be blinded at the cluster level. The process will be carried out by a person not otherwise involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be carried out through computer generated randomized tables in computer software MS Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative data analysis For qualitative data analysis, content of descriptive narratives will be transcribed for thematic analysis through N-vivo software. Both manifest and latent content will be gleaned for arriving at focused themes.
A framework (thematic) analysis will be done on the transcripts through:
1. Familiarization with the data, reading of the field notes and transcribing of the data. Initial coding will be developed from issues emerging from the familiarization stage.
2. The process of applying codes to the data. Textual codes will be used to identify specific pieces of corresponding data and differing themes.
3. Development of themes emerging from the discourse.

Quantitative Data Analysis
Quantitative data will be entered, cleaned and analyzed using SPSS IBM 19. Standard approaches to compare means and proportions will be used for the quantitative analysis. Baseline and endline survey data will be analyzed in terms of information on per cent of children with pneumonia and diarrhea receiving care from any source, prevalence of both diseases, as well as care giver practices (ORS/RHF/antibiotic use). Proportion of children with diarrhea and pneumonia correctly treated by LHWs will be computed as proportions from skill assessment data. LHWs and LHSs correctly practicing various CCM skills in terms of proportions will be done through analysis of data from scorecards. Knowledge adequacy will be judged in terms of mean scores for LHWs and LHSs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2017
Actual
1/06/2017
Date of last participant enrolment
Anticipated
30/09/2019
Actual
30/09/2019
Date of last data collection
Anticipated
30/09/2019
Actual
30/09/2019
Sample size
Target
38
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 8564 0
Pakistan
State/province [1] 8564 0
Sindh

Funding & Sponsors
Funding source category [1] 295321 0
Charities/Societies/Foundations
Name [1] 295321 0
Bill and Melinda Gates Foundation
Country [1] 295321 0
United States of America
Primary sponsor type
University
Name
Centre of Excellence, Division of Women and Child Health, Aga Khan University
Address
Aga Khan University, Stadium Road, Karachi, Pakistan. 74800
Country
Pakistan
Secondary sponsor category [1] 294143 0
None
Name [1] 294143 0
Address [1] 294143 0
Country [1] 294143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296653 0
Ethics Review Committee, Aga Khan University
Ethics committee address [1] 296653 0
Ethics committee country [1] 296653 0
Pakistan
Date submitted for ethics approval [1] 296653 0
16/09/2016
Approval date [1] 296653 0
16/01/2017
Ethics approval number [1] 296653 0
4469-Ped-ERC-16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71526 0
Prof Fauziah Rabbani
Address 71526 0
Department of Community Health Sciences, The Aga Khan University, Stadium Road, Karachi 74800, Sindh province.
Country 71526 0
Pakistan
Phone 71526 0
+92 21 3486 4801
Fax 71526 0
Email 71526 0
fauziah.rabbani@aku.edu
Contact person for public queries
Name 71527 0
Wafa Aftab
Address 71527 0
Department of Community Health Sciences, The Aga Khan University, Stadium Road, Karachi 74800,
Country 71527 0
Pakistan
Phone 71527 0
+92 21 3486 4830
Fax 71527 0
Email 71527 0
wafa.aftab@aku.edu
Contact person for scientific queries
Name 71528 0
Wafa Aftab
Address 71528 0
Department of Community Health Sciences, The Aga Khan University, Stadium Road, Karachi 74800,
Country 71528 0
Pakistan
Phone 71528 0
+92 21 3486 4830
Fax 71528 0
Email 71528 0
wafa.aftab@aku.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChanging perceptions of rural frontline workers and caregivers about management of childhood diarrhea and pneumonia despite several inequities: The nigraan plus trial in pakistan.2021https://dx.doi.org/10.2147/JMDH.S334844
EmbaseDoes supportive supervision intervention improve community health worker knowledge and practices for community management of childhood diarrhea and pneumonia? Lessons for scale-up from Nigraan and Nigraan Plus trials in Pakistan.2021https://dx.doi.org/10.1186/s12960-021-00641-9
N.B. These documents automatically identified may not have been verified by the study sponsor.