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Integrating Pediatric Care Delivery in Rural Healthcare Systems

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ClinicalTrials.gov Identifier: NCT02331082
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
Brigham and Women's Hospital
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Possible

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Infant Mortality Under-two Mortality Other: Structured Quality Improvement Other: Chronic Care Model Device: Integrated Electronic Medical Record Device: Solar-powered electrical supply Behavioral: Performance-based financing Other: Existing healthcare system Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrating Pediatric Care Delivery in Rural Healthcare Systems
Actual Study Start Date : November 1, 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Existing healthcare system
Other: Existing healthcare system
This is the current rural, district-level public sector healthcare infrastructure of rural Nepal that is not strengthened during the study.
Other Name: Control

Experimental: Health System Improvement
Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Other: Structured Quality Improvement
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.
Other Names:
  • Clincal Mentorship
  • Supply Chain Management

Other: Chronic Care Model
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.
Other Names:
  • Task-Shifting
  • Healthcare Systems Strengthening

Device: Integrated 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.
Other Name: Electronic Medical Record

Device: Solar-powered electrical supply
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.
Other Name: Solar Panel

Behavioral: Performance-based financing
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Institutional Birth Rate [ Time Frame: Five years ]
    We expect the intervention will lead to a 25% increase in Institutional Birth Rate among reproductive-age women in the experimental arm.

  2. Antenatal Care Completion Percentage [ Time Frame: Five years ]
    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.

  3. Postpartum contraceptive prevalence rate [ Time Frame: Five years ]
    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.

  4. Preterm delivery rate [ Time Frame: Five years ]
    We expect the intervention will lead to 25% fewer preterm births in the experimental arm.

  5. Low birthweight delivery rates [ Time Frame: Five years ]
    We expect the intervention will lead to a 25% reduction in babies born with low birthweights in the experimental arm

  6. Percentage of stillbirths [ Time Frame: Five years ]
    We expect the intervention will lead to 25% fewer stillbirths in the experimental arm.



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Reproductive age, 15-49 years
  • Resides within 14 village clusters that comprise experimental/control arms

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331082


Contacts
Contact: Duncan Maru, MD, PhD 1-617-553-4256 duncan@possiblehealth.org
Contact: Scott Halliday, MS 1-530-219-8807 scott@possiblehealth.org

Locations
Nepal
Bayalpata Hospital Recruiting
Sanfebagar, Achham, Nepal
Contact: Aradhana Thapa, MPH       aradhana@possiblehealth.org   
Contact: Bikash Gauchan, MBBS       bikash@possiblehealth.org   
Principal Investigator: David Citrin, PhD, MPH         
Charikot Primary Health Center Recruiting
Bhimeshwor, Dolakha, Nepal
Contact: Aradhana Thapa, MPH       aradhana@possiblehealth.org   
Contact: Binod Dangal, MD-GP       binod@possiblehealth.org   
Principal Investigator: David Citrin, PhD, MPH         
Sponsors and Collaborators
Possible
Brigham and Women's Hospital
National Institutes of Health (NIH)
Investigators
Study Director: David Citrin, PhD, MPH Possible
Study Chair: Biraj Karmacharya, MBBS, MSc University of Washington

Additional Information:
Responsible Party: Possible
ClinicalTrials.gov Identifier: NCT02331082     History of Changes
Other Study ID Numbers: hssnyaya
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Possible:
Infant Mortality
Under-two mortality
Maternal Mortality
Implementation Research
Health Systems Strengthening
Chronic Disease Management
Commuity Health Workers

Additional relevant MeSH terms:
Infant Death
Death
Pathologic Processes