Nyaya Health 2010

PROSPECTIVE STUDY OF SURGICAL CARE SCALE-UP IN A RURAL, RESOURCE-LIMITED

SETTING

Duncan Maru, MD, PHDMed-Peds Noon Conference, February

3, 2011

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Didactic Objectives

1) Think critically about the design of implementation research studies in resource-limited settings

2) Think about the process of applying to NIH during residency

3) Give Duncan feedback without making him cry

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(*ANSWER KEY: KEEP IT SIMPLE*)

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The Need: Implementation Gap in Surgical Care

Two billlion people, a third of the global population live in areas with less than one operating room per 100,000 people

Approximately 11% of death and disability are attributable to surgical diseases

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The Problem: Deploying Surgical Care

WHO has produced Integrated Management for Emergency and Essential Surgical Care, and this has been utilized in several sites

But: no studies have yet prospectively studied the implementation process

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Our Proposal: A Prospective, Implementation Research Study

Prospectively study the implementation of an IMEESC-plus protocol at a district hospital in rural Nepal.

IMEESC: WHO’s current model

IMEESC-plus: includes community-based follow-up and hospital-based quality improvement methods

Study the process using mixed quantitative and qualitative methodologies at the hospital-, staff-, and patient levels

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Study Objectives

1) Rigorously study an innovative model for surgical care (IMEESC-plus)

2) Pilot an implementation research methodology that can be used in a larger multi-site study

3) Generate data for larger scale-up of surgical care worldwide

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Setting: Bayalpata Hospital

Infrastructure development and capacity building, not care provision alone Government collaboration: Government partnership contract for 5 years signed June 2009

– June 2014 Currently one of the highest levels of clinical care in the Far West (2 million people) Over 50,000 patients seen to date

Nyaya Health 2010

Setting: Bayalpata Hospital

25%

35%

19%

21%

Distance walked by patients for X-Ray services (each way)

0-3 hrs

3-6 hrs

6-10 hrs

>10 hrs

Nyaya Health 2010

Setting: Bayalpata Hospital

Nyaya Health 2010

Setting: Bayalpata Hospital

Nyaya Health 2010

Setting: Bayalpata Hospital

Nyaya Health 2010

Setting: Bayalpata Hospital

Nyaya Health 2010

Setting: Bayalpata Hospital

Nyaya Health 2010

Setting: Bayalpata Hospital

Nyaya Health 2010

Setting: Bayalpata Hospital

Nyaya Health 2010

Setting: Bayalpata Hospital

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Setting: Community Health Outreach Program

Nyaya Health 2010

Setting: Community Health Outreach Program

Builds off of government’s existing female community health volunteer program

Pays incentives for their work; not salary as per government mandate

Focuses on follow-up and referral

SIMPLE referral system from the hospital

Catchment of 1,357 households covered by 35 FCHVs

Managed by salaried community health advocate (approximately 9-14 FCHVs per community health advocate)

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Setting: Quality Improvement Programming

Mortality and morbidity conferences

Checklists

Data-driven plan-do- study-act strategies

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Translating Idea to Action…

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Funding Mechanisms for a career in Global Health

Organizational: serviceSocial entrepreneurship grants, foundation development

grants, individual donors

Academic: researchNIH, though only a few of its 27 centers really applySome (few) foundations like Doris Duke

Clinical work in the States

For-profit entrepreneurship

Ultimately, the bottom line is the bottom line

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NIH: A core academic funding mechanism

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Picture from: Janet Hall, MD. “Grantwriting: Who Reviews Grants?”

Nyaya Health 2010

R21: PA10-040 Implementation Research

This Funding Opportunity Announcement (FOA) encourages investigators to submit research grant applications that will identify, develop, and refine effective and efficient methods, structures, and strategies to disseminate and implement research-tested health behavior change interventions and evidence-based prevention, early detection, diagnostic, treatment, and quality of life improvement services into public health and clinical practice settings.

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Collaborators

Center for Surgery and Public Health(R21 PI: Selwyn Rogers)Experience in surgical researchLarge network of surgeons and researchers

Nyaya Health (R21 PI: Duncan Maru) Experience in clinical epidemiologyGrassroots implementation in rural Nepal

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Challenges with NIH Mechanism for Global Health Work

BudgetingOriginal (R03) Budget: $95K over two years, primarily for local

staff salaries and co-PI travelUpon Reviewing: $241K over two years, with large sums

for indirect costs and consultant fees; switched to R21

Institutional bureaucracy to navigate

Balancing competing needs for service and research

Mentorship

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Study Objectives

1) Rigorously study an innovative model for Surgical Care (IMEESC-plus)

2) Pilot an implementation research methodology that can be used in a larger multi-site study

3) Generate data for larger scale-up of Surgical Care worldwide

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Levels of Analysis Important to Implementation Science

1) Hospital Operations

2) Human Resources

3) Patients

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Hospital-Level Outcomes

Deliverable: micro-costing for use in larger implementations and studies

Specific Aim 1: We will quantify the raw financial inputs into the system, including total costs and broken down by pharmaceutical, capital equipment, consumables, and facilities construction and maintenance. We hypothesize that the overall construction and two-year operating costs of implementing the WHO surgical model will be $0.50 per capita in the district.

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Nyaya Health 2010

Hospital-Level Outcomes

Deliverable: supply chain utilization data for use in larger implementations and studies

Specific Aim 2: We will tabulate the pharmaceutical and consumable items utilized during the roll-out process. We will assess institutional adherence to supply chain protocols for appropriate stocking of emergency and surgical equipment and consummable goods. This will be based on the WHO Monitoring and Evaluation Tool. We hypothesize there will be a steady compliance to stocking protocols, with approximately 5-10% missing stock items on a monthly basis throughout the study period.

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Nyaya Health 2010

Staff-level Outcomes

Deliverable: rich, qualitative descriptions of human resource management

Specific Aim 3: We will document the scale-up process qualitatively from the staff’s perspectives. This will be done through three modalities: open-ended, semi-structured interviews of staff at three-monthly periods; non-participant observation of planning meetings; and focus groups with staff at three-monthly periods. The primary domains of analysis will include: human resource management, supply chains, in-hospital work flows, and patient-level interactions.

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Nyaya Health 2010

Staff-level Outcomes

Deliverable: evaluation during the roll-out phase with the well-tested surgical safety checklist

Specific Aim 4: We will assess staff adherence to the Surgical Safety Checklist. We hypothesize that adherence rates will improve rapidly over the first six months of implementation to achieve 95% adherence and then stabilize subsequently.

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Nyaya Health 2010

Staff-level Outcomes

Deliverable: evaluation during the roll-out phase with the well-tested surgical safety checklist

Specific Aim 5: We will assess how rapidly hospital staff achieve 95% compliance with resuscitation protocols, as determined by a post-resuscitation evaluation form. We hypothesize that this will occur within six months of implementation.

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Nyaya Health 2010

Patient-Level Outcomes

Deliverable: data on surgical type and volume during the roll-out process

Specific Aim 6: We will quantify the type of surgical diseases and their treatment using a simple data recording instrument. We hypothesize there that there will be a gradual expansion over time of more complex diagnoses and surgical procedures, and that this expansion will be steep over the first 6 months and hit a plateau by 18 months, and by 18 months the annual number of surgeries will approach 20 per 10,000 citizens.

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Nyaya Health 2010

Patient-level Outcomes

Deliverable: evaluation of post-surgical discharge processes

Specific Aim 7: We will assess how rapidly improvements occur in patient follow-up one week following discharge from the hospital. Based on existing experience at the hospital, we hypothesize that 50% of patients will be brought back for a one-week follow-up visit by three months, 65% by six months, and 80% by one year.

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Nyaya Health 2010

Patient-level Outcomes

Deliverable: describe complications data during the surgical roll-out process

Specific Aim 8: We will assess the speed by which newly implemented essential Surgical Care are able to achieve target major complication rates (<5%). We hypothesize that the time to achieve this will be within one year.

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Nyaya Health 2010

Study Objectives

1) Rigorously study an innovative model for Surgical Care (IMEESC-plus)

2) Pilot an implementation research methodology that can be used in a larger multi-site study

3) Generate data for larger scale-up of Surgical Care worldwide

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Concluding Thoughts

Concluding Thoughts

Unmet research need in surgical service delivery

Bayalpata Hospital well-positioned (sort of) as a research site

NIH is a primary mechanism for funding this kind of research

Huge barriers remain in implementing this research

Simplicity is key

On Planners and Searchers

Nyaya Health 2010

References1. Abdullah F, Choo S, Hesse A, Abantanga F, Sory E, et al. (2010) Assessment of Surgical and Obstetrical Care at 10 District Hospitals in Ghana Using On-Site Interviews. J Surg Res. 2. Choo S, Perry H, Hesse A, Abantanga F, Sory E, et al. (2010) Assessment of capacity for surgery, obstetrics and anaesthesia in 17 Ghanaian hospitals using a WHO assessment tool. Trop Med Int Health. 3. Galukande M, von S, Wladis A, Mbembati N, de M, et al. (2010) Essential surgery at the district hospital: a retrospective descriptive analysis in three African countries. PLoS Med. 74. Kruk M, Wladis A, Mbembati N, Ndao-Brumblay S, Hsia R, et al. (2010) Human resource and funding constraints for essential surgery in district hospitals in Africa: a retrospective cross-sectional survey. PLoS Med. 75. Kushner A, Cherian M, Noel L, Spiegel D, Groth S, et al. (2010) Addressing the Millennium Development Goals from a surgical perspective: essential surgery and anesthesia in 8 low- and middle-income countries. Arch Surg. 145: 154-159.6. Contini S, Taqdeer A, Cherian M, Shokohmand A, Gosselin R, et al. (2010) Emergency and essential Surgical Care in Afghanistan: still a missing challenge. World J Surg. 34: 473-479.7. Bickler S, Spiegel D (2010) Improving surgical care in low- and middle-income countries: a pivotal role for the World Health Organization. World J Surg. 34: 386-390.8. Osen H, Chang D, Choo S, Perry H, Hesse A, et al. (2010) Validation of the World Health Organization Tool for Situational Analysis to Assess Emergency and Essential Surgical Care at District Hospitals in Ghana. World J Surg. 9. (2011/01/28) Integrated Management for Emergency and Essential Surgical Care Tool Kit. Available: http://www.who.int/surgery/publications/imeesc/en/index.html. Accessed 0/28/111.10. (2011/01/28) Monitoring and Evaluation Tool for Emergency and Essential Surgical Care. Available: http://www.who.int/surgery/publications/MonitoringEvaluationtoolwithEEE.pdf. Accessed 0/28/111.11. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AHS, et al. (2009) A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 360: 491-499.12. Luboga S, Macfarlane S, von S, Kruk M, Cherian M, et al. (2009) Increasing access to Surgical Care in sub-saharan Africa: priorities for national and international agencies recommended by the Bellagio Essential Surgery Group. PLoS Med. 613. (2011/01/28) Best Practice Protocols: Clinical Procedures Safety-- WHO Manual. Available: http://www.who.int/surgery/publications/BestPracticeProtocolsCPSafety07.pdf. Accessed 0/28/111.14. (2011/01/28) Surgical Care at the District Hospital - The WHO Manual. Available: http://www.who.int/surgery/publications/scdh_manual/en/index.html. Accessed 0/28/111.15. Schwarz D. Implementing a Hospital-Based Morbidity and Mortality Conference in Remote Rural Nepal (in preparation). 16. Surgical Care Wiki Page. Available: http://wiki.nyayahealth.org/SurgicalServices. Accessed 2/2/2011.17. X-Ray Wiki Page. Available: http:// http://wiki.nyayahealth.org/X-Ray/.18. Dindo D, Demartines N, Clavien P (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 240: 205-213.19. Data Management Wiki Page. Available: http://wiki.nyayahealth.org/DataManagement.

Nyaya Health 2010

Acknowledgements

The staff of Bayalpata Hospital & the people of Achham, Nepal

The volunteers and individual donors of Nyaya Health

Dr. Selwyn Rogers and Tess Panizales of the CSPH

The Nepali Ministry of Health & Achham District Health officials: Dr. Deepak Gaylal, Mr. Sailendra Shrestha, Mr. Jhanak Dhungana

Wizfolio and Dropbox

Institutional Supporters: Abbot Laboratories, AMD and the Open Architecture Network, America Nepal Medical Foundation (ANMF), BWH COE in Quality and Safety, Buddha Air, Cents of Relief, Child Health Foundation, CIWEC Clinic (Menlha Nursing Home), Ella Lyman Cabot Trust, EquityEditors Association, Ford Foundation, Frederick Lovejoy Foundation, Google Grants, Nepal Ministry of Health and Population (MOHP), New Aid Foundation, Partners in Health, QBC Diagnostics, Quidel Corporation, Singapore Internet Research Center, Ten Friends, The Hunger Site, The International Foundation, The Shelley and Donald Rubin Foundation, Until There's a Cure Foundation, UpToDate, William Prusoff Foundation, Yale University