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Prospective Study of Surgical Care Scale-Up in a Rural, Resource-Limited Setting Duncan Maru, MD, PHDMed-Peds Noon Conference, February 3, 2011
Didactic Objectives Think critically about the design of implementation research studies in resource-limited settings Think about the process of applying to NIH during residency Give Duncan feedback without making him cry (*ANSWER KEY: KEEP IT SIMPLE*) 1
The Need: Implementation Gap in Surgical Care ,[object Object]
 Approximately 11% of death and disability are attributable to surgical diseases2
The Problem: Deploying Surgical Care ,[object Object]
But: no studies have yet prospectively studied the implementation process3
Our Proposal: A Prospective, Implementation Research Study ,[object Object]
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 levels4
Study Objectives Rigorously study an innovative model for surgical care (IMEESC-plus) Pilot an implementation research methodology that can be used in a larger multi-site study Generate data for larger scale-up of surgical care worldwide 5
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
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Bayalpata Hospital
Setting: Community Health OutreachProgram
Setting: Community Health Outreach Program ,[object Object]
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)17
Setting: Quality Improvement Programming ,[object Object]
Checklists
Data-driven plan-do-					    study-act strategies18
Translating Idea to Action… 19
Funding Mechanisms for a career in Global Health ,[object Object]
Social entrepreneurship grants, foundation development grants, individual donors
Academic: research
NIH, though only a few of its 27 centers really apply
Some (few) foundations like Doris Duke
Clinical work in the States
For-profit entrepreneurshipUltimately, the bottom line is the bottom line 20

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Harvard Internal Medicine-Pediatrics Noon Conference Feb 3, 2011

  • 1. Prospective Study of Surgical Care Scale-Up in a Rural, Resource-Limited Setting Duncan Maru, MD, PHDMed-Peds Noon Conference, February 3, 2011
  • 2. Didactic Objectives Think critically about the design of implementation research studies in resource-limited settings Think about the process of applying to NIH during residency Give Duncan feedback without making him cry (*ANSWER KEY: KEEP IT SIMPLE*) 1
  • 3.
  • 4. Approximately 11% of death and disability are attributable to surgical diseases2
  • 5.
  • 6. But: no studies have yet prospectively studied the implementation process3
  • 7.
  • 9. IMEESC-plus: includes community-based follow-up and hospital-based quality improvement methods
  • 10. Study the process using mixed quantitative and qualitative methodologies at the hospital-, staff-, and patient levels4
  • 11. Study Objectives Rigorously study an innovative model for surgical care (IMEESC-plus) Pilot an implementation research methodology that can be used in a larger multi-site study Generate data for larger scale-up of surgical care worldwide 5
  • 12. 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
  • 22. Setting: Community Health OutreachProgram
  • 23.
  • 24. Pays incentives for their work; not salary as per government mandate
  • 25. Focuses on follow-up and referral
  • 26. SIMPLE referral system from the hospital
  • 27. Catchment of 1,357 households covered by 35 FCHVs
  • 28. Managed by salaried community health advocate (approximately 9-14 FCHVs per community health advocate)17
  • 29.
  • 31. Data-driven plan-do- study-act strategies18
  • 32. Translating Idea to Action… 19
  • 33.
  • 34. Social entrepreneurship grants, foundation development grants, individual donors
  • 36. NIH, though only a few of its 27 centers really apply
  • 37. Some (few) foundations like Doris Duke
  • 38. Clinical work in the States
  • 39. For-profit entrepreneurshipUltimately, the bottom line is the bottom line 20
  • 40. NIH: A core academic funding mechanism Picture from: Janet Hall, MD. “Grantwriting: Who Reviews Grants?” 21
  • 41.
  • 42.
  • 44. Large network of surgeons and researchers
  • 45. Nyaya Health (R21 PI: Duncan Maru)
  • 46. Experience in clinical epidemiology
  • 48.
  • 49. Original (R03) Budget: $95K over two years, primarily for local staff salaries and co-PI travel
  • 50. Upon Reviewing: $241K over two years, with large sums for indirect costs and consultant fees; switched to R21
  • 52. Balancing competing needs for service and research
  • 54. Study Objectives Rigorously study an innovative model for Surgical Care (IMEESC-plus) Pilot an implementation research methodology that can be used in a larger multi-site study Generate data for larger scale-up of Surgical Care worldwide 25
  • 55. Levels of Analysis Important to Implementation Science Hospital Operations Human Resources Patients 26
  • 56.
  • 57. 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. 27
  • 58.
  • 59. 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. 28
  • 60.
  • 61. 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.29
  • 62.
  • 63. 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.30
  • 64.
  • 65. 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.31
  • 66.
  • 67.
  • 68. 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.33
  • 69.
  • 70. 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.34
  • 71. Study Objectives Rigorously study an innovative model for Surgical Care (IMEESC-plus) Pilot an implementation research methodology that can be used in a larger multi-site study Generate data for larger scale-up of Surgical Care worldwide 35
  • 72.
  • 73. Bayalpata Hospital well-positioned (sort of) as a research site
  • 74. NIH is a primary mechanism for funding this kind of research
  • 75. Huge barriers remain in implementing this research
  • 77.
  • 78.
  • 79. The volunteers and individual donors of Nyaya Health
  • 80. Dr. Selwyn Rogers and Tess Panizales of the CSPH
  • 81. The Nepali Ministry of Health & Achham District Health officials: Dr. Deepak Gaylal, Mr. SailendraShrestha, Mr. JhanakDhungana
  • 83. 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