Infant MortalityNCT02331082
Integrating Pediatric Care Delivery in Rural Healthcare Systems
A study testing Structured Quality Improvement, Chronic Care Model and Integrated Electronic Medical Record in people with Infant Mortality and Under-two Mortality, run by Possible at 2 sites in Nepal.
Trial summary
Globally, over seven million children under the age of five die each year, although a suite of interventions-safe delivery care, neonatal care and resuscitation, and management of childhood diarrhea, malnutrition, and pneumonia-can prevent many of these deaths when implemented within functioning health systems. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Mortality, Under-two Mortality
- What is being tested?
- Structured Quality Improvement, Chronic Care Model and Integrated Electronic Medical Record
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 2 sitesNepal
- Study dates
- 1 Nov 2014to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Reproductive age, 15-49 years
- Resides within 14 village clusters that comprise experimental/control arms
Who cannot join
- n/a
Trial locations and contacts
2 sites in 1 country.
Nepal2 sites, 2 recruiting
- Recruiting
Charikot Primary Health Center
Bhimeshwor, Dolakha
Aradhana Thapa, MPH, aradhana@possiblehealth.org
Binod Dangal, MD-GP, binod@possiblehealth.org
- Recruiting
Bayalpata Hospital
Sanfebagar, Achham
Aradhana Thapa, MPH, aradhana@possiblehealth.org
Bikash Gauchan, MBBS, bikash@possiblehealth.org
About this study
Globally, over seven million children under the age of five die each year, although a suite of interventions-safe delivery care, neonatal care and resuscitation, and management of childhood diarrhea, malnutrition, and pneumonia-can prevent many of these deaths when implemented within functioning health systems. This study will include a quasi experimental, stepped wedge, cluster-controlled trial of a mobile health care coordination and quality improvement intervention designed to facilitate comprehensive health systems strengthening. It will do this through training and equipping community-level health care clinics to manage chronic diseases through use of the Chronic Care Model, structured quality improvement sessions to promote clinical mentorship, and use of an integrated electronic medical record to provide real-time data for disease surveillance. The investigators hypothesize that improving upon the health system in these ways will lead to a 25% reduction in under-two mortality through improved services for the citizens of Achham, Nepal.
Read the detailed description
Introduction: A central challenge in the delivery of evidence-based interventions to promote under-five child survival is the coordination of care across the multiple tiers of the health system, from frontline health workers, to primary care clinics, to district hospitals, to specialty providers. Additionally, children who survive or avoid once-fatal diseases such as congenital and rheumatic heart diseases, prematurity, neurodevelopmental conditions, and disabilities sustained from traumatic injuries, are increasingly living well into adolescence, young adulthood, and beyond. Healthcare delivery systems in resource-limited settings, however, are ill-equipped to manage such patients' care. Mobile technologies, coupled with effective management strategies, may enhance implementation and coordination of evidence-based interventions, but few controlled trials exist to validate this. Particularly lacking are strategies that incorporate mobile technologies in an integrated manner across the health system.
Intervention: We have developed a mobile health care coordination and quality improvement intervention within two rural district healthcare systems in Nepal, where the child mortality rate is an estimated 82 per 1,000, and coordination of child health care is poor. Firstly, the intervention aims to increase the timely engagement in acute care for children under the age of five to receive evidence-based World Health Organization protocols aimed at reducing child mortality-Integrated Management of Pregnancy and Childbirth, Integrated Management of Childhood Illness, Integrated Management of Emergency and Essential Surgical Care, and Community-based Management of Severe Acute Malnutrition. Secondly, the intervention aims to implement a Chronic Care Model for pediatric patients under the age of twenty suffering from a chronic disease (congenital and rheumatic heart disease, diabetes, depression, epilepsy, asthma, musculoskeletal and neurodevelopmental disabilities, and pre- and post-surgical conditions).
Analysis: We will conduct a quasi-experimental, stepped-wedge, cluster-controlled trial. The primary outcome of this trial will be under-two mortality. We hypothesize a 25% reduction in under-two mortality rate during the intervention periods, relative to the control period. We hypothesize a 50% improvement in follow-up rates, a 30% improvement in global symptoms score, a 20% reduction in disability score, and a 20% reduction in inpatient days in hospital. We will use both quantitative and qualitative methods to assess the scalability of the intervention in terms of logistics, human resources, costs, and utilization.
Impact: Rigorous evaluations of systems-level child healthcare interventions are needed to drive global healthcare policies and their implementation. The trial proposed here will inform the potential impact and scalability of health systems strengthening interventions.
- Conditions
- Infant Mortality, Under-two Mortality
- Being tested
- Structured Quality Improvement, Chronic Care Model, Integrated Electronic Medical Record, Solar-powered electrical supply, Performance-based financing
- Keywords
- Infant Mortality, Under-two mortality, Maternal Mortality, Implementation Research, Health Systems Strengthening, Chronic Disease Management, Commuity Health Workers
- Medical subject headings
- Infant Death, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Quality ImprovementOther
Also called Clincal Mentorship, Supply Chain Management
For structured quality improvement, trained healthcare providers (primarily doctors from referral hospital) will serve as mentors to mid-level providers. The mentors will facilitate on-site trainings of primary care with mid-level providers at the district hospital. Mentors will also travel monthly to the healthcare facilities themselves to provide training both in the direct context of clinical care and to provide feedback based upon surveillance and monitoring data. The focus will be on the techniques from the Institute for Healthcare Improvement's Model for Improvement, including Plan-Do-Study-Act cycles, run charts, and root cause analyses. Finally, they will work with the clinical healthcare staff to identify resource needs from the local government for maintenance, water, electricity, and supplies. These resource needs will be addressed through an integrated supply chain management system across the tiers of the healthcare system.
Chronic Care ModelOther
Also called Task-Shifting, Healthcare Systems Strengthening
Senior physicians trained in mentorship of non-physician mid-level providers will provide decision support for mid-level providers in the current district healthcare system with specific protocols for target conditions. We will add the following elements: focus on mid-level, non-physician providers as the primary clinicians within the intervention; intensive Community Health Worker (CHW) outreach for detection, screening, follow-up of patients, and encouragement of patient self-care and behavior change; and focused effort on the seamless care coordination of patients across the tiers of the system. Through trainings of CHWs, much of patient self-management comes in the form of home visits that reinforce clinic and hospital counseling, including risk management and prevention. CHWs will be trained in the counseling of each target condition, with counseling largely occurring in the patients' homes, where much of the challenges of chronic disease management and behavior change lie.
Integrated Electronic Medical RecordDevice
Also called Electronic Medical Record
Clinical information systems. We are developing a system for tracking patients that integrates across each of the tiers using an electronic medical record. This is a key technology in supporting each of the above delivery system design elements.
Solar-powered electrical supplyDevice
Also called Solar Panel
As a component of our comprehensive healthcare systems strengthening intervention, we are installing solar panels at community-level clinics to ensure continuous electrical supply for medical devices and technology.
Performance-based financingBehavioural
As part of our healthcare systems strengthening intervention, we have established a performance-based financing agreement with the Government of Nepal that conditionally funds healthcare delivery based on population-level health outcomes and quality healthcare service delivery. In this arrangement, the Government serves as a regulator of healthcare delivery rather than a primary provider of healthcare services.
Existing healthcare systemOther
Also called Control
This is the current rural, district-level public sector healthcare infrastructure of rural Nepal that is not strengthened during the study.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Existing healthcare system Receives: Other: Existing healthcare system |
| Health System Improvement | Experimental | Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing Receives: Other: Structured Quality Improvement; Other: Chronic Care Model; Device: Integrated Electronic Medical Record; Device: Solar-powered electrical supply; Behavioral: Performance-based financing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Under-two mortality rate
We expect the intervention will lead to a 25% decrease in under-two mortality in the experimental arm.
Measured: Five years
Infant mortality rate
We expect the intervention will lead to a 25% decrease in the infant mortality rate in the experimental arm.
Measured: Five years
Neonatal mortality rate
We expect the intervention will lead to a 25% decrease in the neonatal mortality rate in the experimental arm.
Measured: Five years
Secondary outcomes (6)
Institutional Birth Rate
We expect the intervention will lead to a 25% increase in Institutional Birth Rate among reproductive-age women in the experimental arm.
Measured: Five years
Antenatal Care Completion Percentage
We expect the intervention will lead to a 25% increase in number of pregnant women completing all 4 antenatal care visits in the experimental arm.
Measured: Five years
Postpartum contraceptive prevalence rate
We expect the intervention will lead to a 20% increase in postpartum contraceptive prevalence rate among reproductive age women who have delivered in the past 2 years in the experimental arm.
Measured: Five years
Preterm delivery rate
We expect the intervention will lead to 25% fewer preterm births in the experimental arm.
Measured: Five years
Low birthweight delivery rates
We expect the intervention will lead to a 25% reduction in babies born with low birthweights in the experimental arm
Measured: Five years
Percentage of stillbirths
We expect the intervention will lead to 25% fewer stillbirths in the experimental arm.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study start1 Nov 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Possible
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- David Citrin, PhD, MPH, Study director, PossibleBiraj Karmacharya, MBBS, MSc, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331082
- Sponsor's protocol ID
- hssnyaya
- Status last verified
- Dec 2017
- First submitted
- 8 Aug 2013
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Pediatric Care Delivery in Rural Healthcare Systems
- ClinicalTrials.gov ID
- NCT02331082
- Acronym / sponsor ID
- hssnyaya
- Conditions
- Infant Mortality, Under-two Mortality
- Keywords
- Infant Mortality, Under-two mortality, Maternal Mortality, Implementation Research, Health Systems Strengthening, Chronic Disease Management, Commuity Health Workers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- PossibleUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institutes of Health (NIH)
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Globally, over seven million children under the age of five die each year, although a suite of interventions-safe delivery care, neonatal care and resuscitation, and management of childhood diarrhea, malnutrition, and pneumonia-can prevent many of these deaths when implemented within functioning health systems. This study will include a quasi experimental, stepped wedge, cluster-controlled trial of a mobile health care coordination and quality improvement intervention designed to facilitate comprehensive health systems strengthening. It will do this through training and equipping community-level health care clinics to manage chronic diseases through use of the Chronic Care Model, structured quality improvement sessions to promote clinical mentorship, and use of an integrated electronic medical record to provide real-time data for disease surveillance. The investigators hypothesize that improving upon the health system in these ways will lead to a 25% reduction in under-two mortality through improved services for the citizens of Achham, Nepal.
Detailed description
Introduction: A central challenge in the delivery of evidence-based interventions to promote under-five child survival is the coordination of care across the multiple tiers of the health system, from frontline health workers, to primary care clinics, to district hospitals, to specialty providers. Additionally, children who survive or avoid once-fatal diseases such as congenital and rheumatic heart diseases, prematurity, neurodevelopmental conditions, and disabilities sustained from traumatic injuries, are increasingly living well into adolescence, young adulthood, and beyond. Healthcare delivery systems in resource-limited settings, however, are ill-equipped to manage such patients' care. Mobile technologies, coupled with effective management strategies, may enhance implementation and coordination of evidence-based interventions, but few controlled trials exist to validate this. Particularly lacking are strategies that incorporate mobile technologies in an integrated manner across the health system.
Intervention: We have developed a mobile health care coordination and quality improvement intervention within two rural district healthcare systems in Nepal, where the child mortality rate is an estimated 82 per 1,000, and coordination of child health care is poor. Firstly, the intervention aims to increase the timely engagement in acute care for children under the age of five to receive evidence-based World Health Organization protocols aimed at reducing child mortality-Integrated Management of Pregnancy and Childbirth, Integrated Management of Childhood Illness, Integrated Management of Emergency and Essential Surgical Care, and Community-based Management of Severe Acute Malnutrition. Secondly, the intervention aims to implement a Chronic Care Model for pediatric patients under the age of twenty suffering from a chronic disease (congenital and rheumatic heart disease, diabetes, depression, epilepsy, asthma, musculoskeletal and neurodevelopmental disabilities, and pre- and post-surgical conditions).
Analysis: We will conduct a quasi-experimental, stepped-wedge, cluster-controlled trial. The primary outcome of this trial will be under-two mortality. We hypothesize a 25% reduction in under-two mortality rate during the intervention periods, relative to the control period. We hypothesize a 50% improvement in follow-up rates, a 30% improvement in global symptoms score, a 20% reduction in disability score, and a 20% reduction in inpatient days in hospital. We will use both quantitative and qualitative methods to assess the scalability of the intervention in terms of logistics, human resources, costs, and utilization.
Impact: Rigorous evaluations of systems-level child healthcare interventions are needed to drive global healthcare policies and their implementation. The trial proposed here will inform the potential impact and scalability of health systems strengthening interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Existing healthcare systemExisting healthcare system |
| Health System Improvement | Experimental | Other: Structured Quality Improvement, Other: Chronic Care Model, Device: Integrated Electronic Medical Record, Device: Solar-powered electrical supply, Behavioral: Performance-based financingStructured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female
- Reproductive age, 15-49 years
- Resides within 14 village clusters that comprise experimental/control arms
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Quality ImprovementAlso: Clincal Mentorship, Supply Chain ManagementFor structured quality improvement, trained healthcare providers (primarily doctors from referral hospital) will serve as mentors to mid-level providers. The mentors will facilitate on-site trainings of primary care with mid-level providers at the district hospital. Mentors will also travel monthly to the healthcare facilities themselves to provide training both in the direct context of clinical care and to provide feedback based upon surveillance and monitoring data. The focus will be on the techniques from the Institute for Healthcare Improvement's Model for Improvement, including Plan-Do-Study-Act cycles, run charts, and root cause analyses. Finally, they will work with the clinical healthcare staff to identify resource needs from the local government for maintenance, water, electricity, and supplies. These resource needs will be addressed through an integrated supply chain management system across the tiers of the healthcare system. | Other | Health System Improvement |
| Chronic Care ModelAlso: Task-Shifting, Healthcare Systems StrengtheningSenior physicians trained in mentorship of non-physician mid-level providers will provide decision support for mid-level providers in the current district healthcare system with specific protocols for target conditions. We will add the following elements: focus on mid-level, non-physician providers as the primary clinicians within the intervention; intensive Community Health Worker (CHW) outreach for detection, screening, follow-up of patients, and encouragement of patient self-care and behavior change; and focused effort on the seamless care coordination of patients across the tiers of the system. Through trainings of CHWs, much of patient self-management comes in the form of home visits that reinforce clinic and hospital counseling, including risk management and prevention. CHWs will be trained in the counseling of each target condition, with counseling largely occurring in the patients' homes, where much of the challenges of chronic disease management and behavior change lie. | Other | Health System Improvement |
| Integrated Electronic Medical RecordAlso: Electronic Medical RecordClinical information systems. We are developing a system for tracking patients that integrates across each of the tiers using an electronic medical record. This is a key technology in supporting each of the above delivery system design elements. | Device | Health System Improvement |
| Solar-powered electrical supplyAlso: Solar PanelAs a component of our comprehensive healthcare systems strengthening intervention, we are installing solar panels at community-level clinics to ensure continuous electrical supply for medical devices and technology. | Device | Health System Improvement |
| Performance-based financingAs part of our healthcare systems strengthening intervention, we have established a performance-based financing agreement with the Government of Nepal that conditionally funds healthcare delivery based on population-level health outcomes and quality healthcare service delivery. In this arrangement, the Government serves as a regulator of healthcare delivery rather than a primary provider of healthcare services. | Behavioural | Health System Improvement |
| Existing healthcare systemAlso: ControlThis is the current rural, district-level public sector healthcare infrastructure of rural Nepal that is not strengthened during the study. | Other | Control |
Primary outcome
Under-two mortality rate
Time frame: Five years
We expect the intervention will lead to a 25% decrease in under-two mortality in the experimental arm.
Infant mortality rate
Time frame: Five years
We expect the intervention will lead to a 25% decrease in the infant mortality rate in the experimental arm.
Neonatal mortality rate
Time frame: Five years
We expect the intervention will lead to a 25% decrease in the neonatal mortality rate in the experimental arm.
6 secondary outcomes
Institutional Birth Rate
Time frame: Five years
Antenatal Care Completion Percentage
Time frame: Five years
Postpartum contraceptive prevalence rate
Time frame: Five years
Preterm delivery rate
Time frame: Five years
Low birthweight delivery rates
Time frame: Five years
Percentage of stillbirths
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- PossibleLink provided by the sponsor.
- Healthcare Systems Design GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Citrin, PhD, MPH study director
Possible
Biraj Karmacharya, MBBS, MSc study chair
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Quality Improvement, Chronic Care Model and Integrated Electronic Medical Record in people with Infant Mortality and Under-two Mortality, run by Possible at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duncan Maru, MD, PhD (1-617-553-4256, duncan@possiblehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Under-two mortality rate (time frame: Five years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.