Condition category
Neonatal Diseases
Date applied
02/05/2017
Date assigned
11/05/2017
Last edited
01/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Around the globe, every year 2.6 million babies die within the mother’s womb (stillbirth) and half of these deaths take place during labour and delivery. Similarly, 2.9 million babies die in the first 28 days of birth (neonatal death). These deaths can be prevented from simple low cost interventions. However, implementing the proven interventions in routine clinical care has proved to be a challenge, especially in low income settings like Nepal. Understanding these challenges within the health system context and developing quality improvement interventions to overcome the barriers is critical. NePeriQIP is a program which aims to improve the behavior of the hospital leaders and decision maker for better clinical care and to build on the capacity of the health workers to set up a system to plan, implement and review the clinical care for mothers and newborns. The aim of this study is to evaluate the effectiveness of NePeriQIP on stillbirth and neonatal death.

Who can participate?
Women who are at least 22 week pregnant and their newborn babies.

What does the study involve?
This study is taking place in 12 hospitals which have a total annual delivery of more than 60,000. For the evaluation purpose, the hospitals are divided into four groups (clusters). In each cluster NePeriQIP program is carried out three months apart. The program involves evaluating the current care given, providing training to health workers to provide better care and to maintain the delivery of this care. Throughout the duration of the study, neonatal death and stillbirth rates are recorded. In addition, health workers are monitored in order to evaluate they are they are providing.

What are the possible benefits and risks of participating?
Participating newborns benefit from receiving improved quality of care which could increase their chance of survival. Health workers benefit from improving their knowledge, skills and performance in looking after newborns. There are no notable risks involved with participating.

Where is the study run from?
Western Regional Hospital and 11 other hospitals (Nepal)

When is the study starting and how long is it expected to run for?
January 2017 to December 2019

Who is funding the study?
1. Swedish Foundation for International Cooperation in Research and Higher Education (Sweden)
2. Swedish Research Council (Sweden)
3. Einhorn Family Foundation (Sweden)
4. UNICEF Nepal (Nepal)

Who is the main contact?
1. Dr Ashish KC (scientific)
aaashis7@yahoo.com
2. Dr Mats Målqvist (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ashish KC

ORCID ID

http://orcid.org/0000-0002-0541-4486

Contact details

UN House
Pulchok
Lalitpur
-
Nepal
+977 9841453806
aaashis7@yahoo.com

Type

Scientific

Additional contact

Dr Mats Målqvist

ORCID ID

Contact details

University Hospital
Uppsala
751 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1643

Study information

Scientific title

Nepal Perinatal Quality Improvement Project (NePeriQIP): A cluster randomized scale-up trial in public hospitals

Acronym

NePeriQIP

Study hypothesis

Primary objective:
To evaluate impact of the NePeriQIP intervention model on intrapartum mortality (intrapartum stillbirth and first day mortality).

Secondary objectives:
1. To evaluate the effect of the intervention model on overall neonatal mortality and morbidity and health worker's performance on neonatal care
2. To evaluate the process of implementation

Ethics approval

Ethical Review Board-Nepal Health Research Council, 16/03/2017, ref: 1643

Study design

Stepped-wedge cluster-randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

1. Babies who have respiratory depression at birth
2. Preterm babies
3. Neonatal Infection
4. Babies with neonatal encephalopathy

Intervention

A stepped-wedge cluster-randomized design will be applied and the hospitals will be randomly allocated to four wedges with different time points for initiation of intervention; each wedge will thus include three hospitals. The delay in intervention start will be three months, meaning that the preparatory phase will be completed for each step before starting the next. Randomization was performed proportionate to number of deliveries per year in each hospital starting by allocating one of the four largest hospitals to each wedge and then continued with the middle-range hospitals. Finally the four hospitals with the least deliveries per year were randomly allocated to each wedge. This implies that all hospitals will eventually receive the intervention with a total duration of 12 months (3 months preparatory phase and 9 months implementation phase). In order to achieve a sustained effect of the intervention the hospital managements will be stimulated to continue beyond the intervention period of 12 months.

A package of multi-faceted quality improvement interventions will be administered to all 12 participating hospitals. The QI interventions will utilize a combination of three different implementation strategies (1) Facilitation, (2) Audit and Feedback, and (3) Training, with the aim to strengthen the health care system through improved quality improvement processes and information systems, and thereby improving quality of perinatal care.

NePeriQIP will be rolled out in three phases: preparatory, implementation and sustainability phase.

Preparatory phase - In order to enable the introduction and implementation of NePeriQIP, mentors will be recruited externally by central Ministry of Health. These mentors will be clinicians with experience of working in perinatal health. They will be responsible for revitalising and orienting the already existing Quality Improvement/Maternal and Perinatal Death Review (QI/MPDR) committees in each hospital to implement the NePeriQIP intervention. Each mentor will be responsible for four hospitals. The QI/MPDR committee will then use set selection criteria to identify in-hospital 2-3 QI facilitators to implement the QI interventions in clinical units in each of the 12 hospitals. The QI facilitators and mentors will be trained on facilitation skills and standard perinatal care package by the research team. Following this, the QI facilitators will together with clinical unit staff, supported by the mentors, conduct assessment of the readiness, availability and quality of perinatal care. Based on the findings, a causal/bottleneck analysis on inadequacy of quality of perinatal care will be conducted. Results will be shared with the QI/MPDR committee and a plan will be developed and implemented to improve the quality of perinatal care using a Plan-Do-Study-Act (PDSA) cycle approach. Together with QI/MPDR committee, the QI facilitators will mobilize resources to ensure availability of perinatal care equipment. Routine use of in-patient sick newborn register will be strengthened to improve the monitoring of perinatal care. This phase will take 3 months to complete.

Implementation phase - The mentors and QI facilitators will conduct training to build capacity of health workers on WHO Standards for Improving Quality of Maternal and Newborn Care in health facilities and the National Neonatal Clinical Protocol. This training will be the starting point of clinical evaluation. The training will also include instructions on how to conduct skills evaluation and how to fill the progress board on a daily basis. Standardized tools (checklists, progress boards and manikins) will be provided to each clinical unit. The QI facilitator will supervise and facilitate the use of these tools and will conduct unit meetings with staff using PDSA cycle and facilitation techniques. After six months of implementation, refresher training will be done to health workers on clinical standards. During the implementation phase the mentors will support and supervise the QI facilitators on a periodical basis and conduct individual in-house training if deemed necessary. The mentors will also encourage and enable interaction between QI facilitators at other hospitals. The implementation phase will be on-going for 9 months.

Sustainability phase - In order to fully implement and sustain the NePeriQIP intervention the QI facilitators will be expected to continue with QI activities as an integral component of daily practice.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Intrapartum mortality measured as intrapartum stillbirth (death within uterus 22 weeks of gestation or birth weight 500 gram) as assessed by review of the patient record at the time of delivery
2. First-day neonatal mortality (deaths within first 24 hours of birth) is assessed by review of the patient record at the time of discharge

Secondary outcome measures

1. Early (0-6 days) and late neonatal (7-27 days) in-hospital mortality is measured by review of the patient record at the time of discharge
2. Admittance to Sick Newborn Care Units (SNCU) and morbidity epidemiology is measured by review of the sick newborn chart and register at the time of discharge
3. Rate and severity of neonatal encephalopathy (NE) is measured by review of the NE scoring sheet at the time of discharge
4. Health workers’ performance on:
4.1. Fetal surveillance in clinical settings is measured by observation and review of the record by surveillance officer during the time of labour
4.2. Neonatal resuscitation in simulated settings is measured by observation by trainers at the time of training
4.3. Neonatal resuscitation in clinical settings is measured by clinical observation by surveillance officers at the time of birth
4.4. Essential newborn care (immediate newborn care, cord care practices, breast feeding, KMC, routine assessment of newborn) is measured by clinical observation at the time of birth and during first hour of life
4.5. Infection prevention and management is measured by clinical observation at delivery unit as well as sick newborn care unit
5. Beneficiaries' satisfaction on the received care is measured by interview with the client at the time of discharge
6. Acceptability and adequacy of each implementation strategy component is measured by focus group discussion and interview with health workers and stakeholders at 3, 6 and 9 months of implementation of the intervention
7. Mothers’ experiences regarding closeness and separation to their infants in the delivery room and at the neonatal care unit is measured by interview at the time of discharge
8. Postnatal staff perceptions on closeness between parents and newborns and what barriers that they can identify at their hospital is measured by interview at 3, 6 and 9 months of implementation of the intervention
9. Cost-effectiveness of the intervention is measured by interview with beneficiary and review of the patient record at the time of discharge

Overall trial start date

02/01/2017

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Mothers:
1. Pregnant women
2. Gestational age equal to or more than 22 weeks
3. With foetal heart sound at admission
4. Agree to participate in the study

Neonates:
Babies weighing 500 gram.

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

There will be 4 wedges with 3 hospital in each wedge. Estimated number of deliveries before intervention-37,000. Estimated number of deliveries after intervention-46,800

Participant exclusion criteria

1. Women who have antepartum stillbirth, i.e. women admitted to labour room with no fetal heart sound

Recruitment start date

01/06/2017

Recruitment end date

31/05/2019

Locations

Countries of recruitment

Nepal

Trial participating centre

Western Regional Hospital
Pokhara, Kaski
Pokhara
44600
Nepal

Trial participating centre

Mid-Western Regional Hospital
Surkhet
Surkhet
21700
Nepal

Trial participating centre

Bardiya district hospital
Guleriya, Bardiya
Gulyeria, Bardiya
21800
Nepal

Trial participating centre

Bharatpur Hospital
Chitwan, Bharatpur
Chitwan
44200
Nepal

Trial participating centre

Seti Zonal Hospital
Dhangadi, Kailali
Dhangadi
10900
Nepal

Trial participating centre

Nuwakot district hospital
Bidhur, Nuwakot
Nuwakot
44909
Nepal

Trial participating centre

Koshi Zonal Hospital
Biratnagar, Morang
Biratnagar, Morang
56600
Nepal

Trial participating centre

Rapti Sub Regional Hospital
Dang
Ghorahi
22400
Nepal

Trial participating centre

Nawalparasi district hospital
Nawalparasi
Sunwal
33000
Nepal

Trial participating centre

Lumbini Zonal Hospital
Butwal, Rupendehi
Butwal
32907
Nepal

Trial participating centre

Bheri Zonal Hospital
Nepalgunj, Bheri
Nepalgunj
21900
Nepal

Trial participating centre

Pyuthan district hospital
Pyuthan
Khalanga
22300
Nepal

Sponsor information

Organisation

Swedish Foundation for International Cooperation in Research and Higher Education (STINT)

Sponsor details

Box 3523
Stockholm
10369
Sweden
+46 8 671 19 90
christofer.carlsson@stint.se

Sponsor type

Government

Website

http://www.stint.se

Organisation

Swedish Research Council (VR)

Sponsor details

Vetenskapsrådet
Västra Järnvägsgatan 3
Stockholm
10138
Sweden
+46 8 546 44 000
vetenskapsradet@vr.se

Sponsor type

Government

Website

http://www.vr.se

Organisation

Einhorn Family Foundation

Sponsor details

Karolinska Universitetssjukhuset
Stockholm
11426
Sweden
+46 8 517 754 69
stefan.einhorn@ki.se

Sponsor type

Charity

Website

http://www.stefaneinhorn.se/Familjen-Einhorns-Stiftelse

Funders

Funder type

Government

Funder name

Swedish Foundation for International Cooperation in Research and Higher Education (STINT)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Research Council (VR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Einhorn Family Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UNICEF Nepal

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol is planned for publication by end of September 2017. The dissemination of the outcome of the trials will be done after the completion of the project in early 2020.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Ashish KC (aaashis7@yahoo.com) after the publication of the full report.

Intention to publish date

31/03/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/05/2017: The benefits and risks of participating have been added to the plain English summary.