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

4. Approximately 11% of death and disability are attributable to surgical diseases2

6. But: no studies have yet prospectively studied the implementation process3

8. IMEESC: WHO’s current model

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

13. Setting: Bayalpata Hospital

14. Setting: Bayalpata Hospital

15. Setting: Bayalpata Hospital

16. Setting: Bayalpata Hospital

17. Setting: Bayalpata Hospital

18. Setting: Bayalpata Hospital

19. Setting: Bayalpata Hospital

20. Setting: Bayalpata Hospital

21. Setting: Bayalpata Hospital

22. Setting: Community Health OutreachProgram

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

30. Checklists

31. Data-driven plan-do- study-act strategies18

32. Translating Idea to Action… 19

34. Social entrepreneurship grants, foundation development grants, individual donors

35. Academic: research

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

43. Experience in surgical research

44. Large network of surgeons and researchers

45. Nyaya Health (R21 PI: Duncan Maru)

46. Experience in clinical epidemiology

47. Grassroots implementation in rural Nepal23

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

51. Institutional bureaucracy to navigate

52. Balancing competing needs for service and research

53. Mentorship24

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

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

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

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

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

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

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

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

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

76. Simplicity is key

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

82. Wizfolio and Dropbox

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