1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [indumathysanthanam@gmail.com].
   


6. For how long will this data be available start date provided 31-12-2027 and end date provided 31-12-2030?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Background and Rationale

Around 2.6 million between the ages of 1 and 59 months, and 2.1 million children beyond 5 years have succumbed. Approximately 27% of these child deaths were reported from South Asia^3,4. Diarrhoea, pneumonia, and sepsis remain important causes of post-neonatal under-5 mortality (U5M)⁵. 

This study has been undertaken to highlight the efforts taken by the National Health Mission Tamil Nadu in reducing U5M. Earlier, in 2017, the state’s post-neonatal U5M was high at 17/1000⁶. Gap analysis revealed that critically ill children were being transferred to the medical college Pediatric ICUs without stabilization. Lack of infrastructure, drugs, consumables, equipment, and trained manpower were some of the reasons cited for the “scoop and run” policy.  

As a result, funds were sanctioned to provide training in Pediatric Resuscitation and Emergency Medicine (PREM means love in all Indian languages) protocols⁷ to front-line staff in district hospitals. PREM earlier known as PEMC was developed from lessons learned from a low-resource, large-volume pediatric emergency department which was staffed by novice residents with little exposure to emergency medicine training in their undergraduate period. A cyclical process was innovated to enable junior front-line doctors to assess the physiological status using the PREM triangle to make therapeutic decisions until stabilization. This approach reduced the need for senior advice, invasive monitoring, and mechanical ventilation and improved in-hospital mortality over 2 decades. 

Based on this data, PREM units were set up in 28 District headquarters/Taluk hospitals, and 4 nurses were recruited per unit⁸. In 2019, the TN H&FW passed a comprehensive Government Order that adopted PREM protocols and training content⁹. Additionally, the state Planning Commission, under the Tamil Nadu Innovative Initiative Fund, sanctioned a high-fidelity simulation laboratory to train doctors and nurses in PREM protocols at the Institute of Child Health-Madras Medical College. 

Post covid, in 2022, NHM-TN extended the PREM initiative to 94 hospitals: Medical colleges, DHQ, and Taluk. Monthly, state-level PREM death audits were conducted via Zoom with all the stakeholders. Daily PREM performance was submitted to the NHM via the Google platform. 

Since the implementation of PREM, annually around 50,000 acutely ill children are being evaluated and resuscitated and the U5M in 2023, TN has dropped to 8.2/1000. However, little evidence exists in support of the PREM initiative.  

Research question

How does the implementation of PREM influence the resuscitation care provided to critically ill or injured children in secondary care, low resource rural hospitals and what system-level, and behavioral factors shape adherence to PREM protocol-based care?

 Primary objectives

1)    To assess the reach, effectiveness, acceptability, adoption, appropriateness, feasibility, fidelity, and penetration following PREM implementation, in 5 rural district hospitals.

Secondary objective:  

The pre and post analysis will be made with respect to the base-line levels of the facility

i)   To assess the proportion of children who were triaged as critically-ill using PREM triage process in the out-patient department.

ii)  To measure compliance with PREM protocols for airway obstruction/ respiratory distress, shock and non-convulsive status epilepticus following successful triage in OPD.   

iii)           To determine compliance with PREM protocols for children rushed into the PREM unit with overt paediatric emergencies.

iv)            To determine the proportion of compliance with PREM documentation and decision-making guidelines during resuscitation.

v)             Proportion transferred out with or without PREM based resuscitation

Methods:

IEC committee of the Directorate of Public health and Preventive Medicine has given approval for conducting the study at the 5 secondary care hospitals (Usilampatti DHQ hospital, Rajapalayam GH, Palladam GH, Pennagaram GH and Kuzhithurai GH. IEC approval is under process in 5 medical college hospitals (Theni Medical College, Virudhunagar Medical College, Tiruppur Medical College, Dharmapuri Medical College and Kanyakumari Medical College) for mentoring and guiding the study sites.  

This is a prospective multicenter before and after implementation-operational study using the RE-AIM framework that will be conducted in 5 secondary care hospitals in rural Tamil Nadu. Quantitative and qualitative data will be obtained prior to the implementation phase:  

Phase I – Pre-implementation (3 months):

Qualitative data: 

Focused group discussion will be held with the stakeholders in the district hospital to understand, the reach, effectiveness, acceptability, adoptability, feasibility and maintenance of the implementation study. Interviews with key clinical/management leaders will be conducted to determine the nature and extent of site barriers to the implementation pathway and training of the staff.

Quantitative data

i) Baseline audit of medical records/ hospital registers to determine baseline clinical performance and PREM pathway performance.  

1. To compare, the proportion of children who present to OPD/ PREM unit with a documented assessment for severity of physiological status before and after the intervention.
2. To compare, the number of children who present to OPD/PREM unit who received PREM based resuscitation before and after the intervention.
3. To compare, whether the care provided to children who present to a hospital is consistent with PREM protocols before and after the intervention.
4. To compare, whether there is a change over time during the study period in the above-mentioned outcomes.

 iii) Audit of PREM infrastructure 

Phase II – Implementation strategy (3 months):

Based on the qualitative and quantitative evaluation, infrastructure and essential resources will be strengthened, PREM training will be provided, and continuous monitoring will be enhanced by the mentoring medical college hospitals. 

Phase III – Post-implementation Evaluation (3 months):Ongoing data collection from participating sites will evaluate the following:  

i) Surveys will be conducted to evaluate acceptability, adoptability, feasibility, penetration and fidelity during this phase.

ii) Number of clinicians and nurses who underwent training.  

iii) Number who used the PREM triage process in the OPD

iv) Number who used the PREM team approach for unresponsiveness

v)Number who are using PREM case records to document

vi) Comparative analysis with baseline data will assess improvements in timely recognition, appropriate resuscitation interventions, and clinical outcomes among critically ill children.

Inclusion criteria

Qualitative and quantitative survey will be collected from the following district hospital participants after obtaining informed consent:

1)    Chief medical officer

2)    Doctors who are posted in the emergency department i.e. Paediatricians and non-paediatricians

3)    Nurses who rotate in the emergency department and paediatrics/ PREM unit

4)    Matron and nursing supervisors

Exclusion criteria

1)    Doctors who are not posted in the Emergency Department

2)    Nurses who work exclusively in the sick neonatal unit/labor ward/OR etc

Outcome Indicators:

Acceptability: Acceptability of implementation measure

Adoptability: Number Initiated/number eligible for Initiation

Fidelity: Checklist or Likert Scale to evaluate how many components are implemented as instructed.

Penetration:

i)               Proportion of doctors who routinely practice PREM protocols/ Total number of clinicians

ii)             Number of patients who receive PREM protocol-based care/ Total number of patients Audits and checklist (See below)

Efficiency indicators:

1. Number of critically ill children triaged every month.

1. The monthly bed occupancy rate in the children’s ward.
2. No of children referred to higher centres after resuscitation.
3. No of children referred without resuscitation.
4. No of children with emergency signs who received critical interventions, Oxygen, fluid bolus, inotrope infusion, CPR, anticonvulsants, nebulization, antibiotics.
5. No of children who were treated until the resolution of therapeutic goals.
6. No of children with emergency signs who did not receive critical interventions, Oxygen, fluid bolus, inotrope infusion, CPR, anticonvulsants, nebulization, antibiotics.
7. No of children who were inadequately treated
8. No of children who were refractory to treatment.
9. Quality of documentation in PREM case record during the study period.

Clinical care indicators:

1. No. of children treated with respiratory distress, pneumonia, asthma, or bronchiolitis.
2. No. of children treated for hypovolemic shock with dehydration.
3. Number of children treated for septic /dengue shock
4. No of children treated for unresponsiveness with abnormal movements
5. No of children treated for envenomation, trauma, poisoning, or other pediatric emergencies.
6. Mortality within 24 hours, mortality within 7 days for all children who are participating in the study.

Service quality indicators:

1. Patient satisfaction score
2. The number of children who LAMA