Med peds noon conference feb 2011


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Med peds noon conference feb 2011

  1. 1. Prospective Study of Surgical Care Scale-Up in a Rural, Resource-Limited Setting<br />Duncan Maru, MD, PHDMed-Peds Noon Conference, February 3, 2011<br />
  2. 2. Didactic Objectives<br />Think critically about the design of implementation research studies in resource-limited settings<br />Think about the process of applying to NIH during residency<br />Give Duncan feedback without making him cry<br />(*ANSWER KEY: KEEP IT SIMPLE*)<br />1<br />
  3. 3. The Need: Implementation Gap in Surgical Care<br /><ul><li> Two billlion people, a third of the global population live in areas with less than one operating room per 100,000 people
  4. 4. Approximately 11% of death and disability are attributable to surgical diseases</li></ul>2<br />
  5. 5. The Problem: Deploying Surgical Care<br /><ul><li>WHO has produced Integrated Management for Emergency and Essential Surgical Care, and this has been utilized in several sites
  6. 6. But: no studies have yet prospectively studied the implementation process</li></ul>3<br />
  7. 7. Our Proposal: A Prospective, Implementation Research Study<br /><ul><li>Prospectively study the implementation of an IMEESC-plus protocol at a district hospital in rural Nepal.
  8. 8. IMEESC: WHO’s current model
  9. 9. IMEESC-plus: includes community-based follow-up and hospital-based quality improvement methods
  10. 10. Study the process using mixed quantitative and qualitative methodologies at the hospital-, staff-, and patient levels</li></ul>4<br />
  11. 11. Study Objectives<br />Rigorously study an innovative model for surgical care (IMEESC-plus)<br />Pilot an implementation research methodology that can be used in a larger multi-site study<br />Generate data for larger scale-up of surgical care worldwide<br />5<br />
  12. 12. Setting: Bayalpata Hospital<br />Infrastructure development and capacity building, not care provision alone<br />Government collaboration: Government partnership contract for 5 years signed June 2009 – June 2014<br />Currently one of the highest levels of clinical care in the Far West (2 million people)<br />Over 50,000 patients seen to date<br />
  13. 13. Setting: Bayalpata Hospital<br />
  14. 14. Setting: Bayalpata Hospital<br />
  15. 15. Setting: Bayalpata Hospital<br />
  16. 16. Setting: Bayalpata Hospital<br />
  17. 17. Setting: Bayalpata Hospital<br />
  18. 18. Setting: Bayalpata Hospital<br />
  19. 19. Setting: Bayalpata Hospital<br />
  20. 20. Setting: Bayalpata Hospital<br />
  21. 21. Setting: Bayalpata Hospital<br />
  22. 22. Setting: Community Health OutreachProgram<br />
  23. 23. Setting: Community Health Outreach Program<br /><ul><li>Builds off of government’s existing female community health volunteer program
  24. 24. Pays incentives for their work; not salary as per government mandate
  25. 25. Focuses on follow-up and referral
  26. 26. SIMPLE referral system from the hospital
  27. 27. Catchment of 1,357 households covered by 35 FCHVs
  28. 28. Managed by salaried community health advocate (approximately 9-14 FCHVs per community health advocate)</li></ul>17<br />
  29. 29. Setting: Quality Improvement Programming<br /><ul><li>Mortality and morbidity conferences
  30. 30. Checklists
  31. 31. Data-driven plan-do- study-act strategies</li></ul>18<br />
  32. 32. Translating Idea to Action…<br />19<br />
  33. 33. Funding Mechanisms for a career in Global Health<br /><ul><li>Organizational: service
  34. 34. Social entrepreneurship grants, foundation development grants, individual donors
  35. 35. Academic: research
  36. 36. NIH, though only a few of its 27 centers really apply
  37. 37. Some (few) foundations like Doris Duke
  38. 38. Clinical work in the States
  39. 39. For-profit entrepreneurship</li></ul>Ultimately, the bottom line is the bottom line<br />20<br />
  40. 40. NIH: A core academic funding mechanism<br />Picture from: Janet Hall, MD. “Grantwriting: Who Reviews Grants?”<br />21<br />
  41. 41. R21: PA10-040 Implementation Research<br /><ul><li>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.</li></ul>22<br />
  42. 42. Collaborators<br /><ul><li>Center for Surgery and Public Health(R21 PI: Selwyn Rogers)
  43. 43. Experience in surgical research
  44. 44. Large network of surgeons and researchers
  45. 45. Nyaya Health (R21 PI: Duncan Maru)
  46. 46. Experience in clinical epidemiology
  47. 47. Grassroots implementation in rural Nepal</li></ul>23<br />
  48. 48. Challenges with NIH Mechanism for Global Health Work<br /><ul><li>Budgeting
  49. 49. Original (R03) Budget: $95K over two years, primarily for local staff salaries and co-PI travel
  50. 50. Upon Reviewing: $241K over two years, with large sums for indirect costs and consultant fees; switched to R21
  51. 51. Institutional bureaucracy to navigate
  52. 52. Balancing competing needs for service and research
  53. 53. Mentorship</li></ul>24<br />
  54. 54. Study Objectives<br />Rigorously study an innovative model for Surgical Care (IMEESC-plus)<br />Pilot an implementation research methodology that can be used in a larger multi-site study<br />Generate data for larger scale-up of Surgical Care worldwide<br />25<br />
  55. 55. Levels of Analysis Important to Implementation Science<br />Hospital Operations<br />Human Resources<br />Patients<br />26<br />
  56. 56. Hospital-Level Outcomes<br /><ul><li>Deliverable: micro-costing for use in larger implementations and studies
  57. 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. </li></ul>27<br />
  58. 58. Hospital-Level Outcomes<br /><ul><li>Deliverable: supply chain utilization data for use in larger implementations and studies
  59. 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. </li></ul>28<br />
  60. 60. Staff-level Outcomes<br /><ul><li>Deliverable: rich, qualitative descriptions of human resource management
  61. 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.</li></ul>29<br />
  62. 62. Staff-level Outcomes<br /><ul><li>Deliverable: evaluation during the roll-out phase with the well-tested surgical safety checklist
  63. 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.</li></ul>30<br />
  64. 64. Staff-level Outcomes<br /><ul><li>Deliverable: evaluation during the roll-out phase with the well-tested surgical safety checklist
  65. 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.</li></ul>31<br />
  66. 66. Patient-Level Outcomes<br /><ul><li>Deliverable: data on surgical type and volume during the roll-out process</li></ul>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. <br />32<br />
  67. 67. Patient-level Outcomes<br /><ul><li>Deliverable: evaluation of post-surgical discharge processes
  68. 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.</li></ul>33<br />
  69. 69. Patient-level Outcomes<br /><ul><li>Deliverable: describe complications data during the surgical roll-out process
  70. 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.</li></ul>34<br />
  71. 71. Study Objectives<br />Rigorously study an innovative model for Surgical Care (IMEESC-plus)<br />Pilot an implementation research methodology that can be used in a larger multi-site study<br />Generate data for larger scale-up of Surgical Care worldwide<br />35<br />
  72. 72. Concluding Thoughts<br />Concluding Thoughts<br /><ul><li> Unmet research need in surgical service delivery
  73. 73. Bayalpata Hospital well-positioned (sort of) as a research site
  74. 74. NIH is a primary mechanism for funding this kind of research
  75. 75. Huge barriers remain in implementing this research
  76. 76. Simplicity is key
  77. 77. On Planners and Searchers</li></li></ul><li>References<br />1. 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: Accessed 0/28/111.10. (2011/01/28) Monitoring and Evaluation Tool for Emergency and Essential Surgical Care. Available: 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: Accessed 0/28/111.14. (2011/01/28) Surgical Care at the District Hospital - The WHO Manual. Available: 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: Accessed 2/2/2011.17. X-Ray Wiki Page. Available: http:// 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:<br />
  78. 78. Acknowledgements<br /><ul><li>The staff of Bayalpata Hospital & the people of Achham, Nepal
  79. 79. The volunteers and individual donors of Nyaya Health
  80. 80. Dr. Selwyn Rogers and Tess Panizales of the CSPH
  81. 81. The Nepali Ministry of Health & Achham District Health officials: Dr. Deepak Gaylal, Mr. SailendraShrestha, Mr. JhanakDhungana
  82. 82. Wizfolio and Dropbox
  83. 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</li>