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Metric-Driven Surgical Care Delivery in Rural Settings of Extreme Poverty: Prospective Implementation Science Study in Rural Nepal ABSTRACT Introduction While over 11% of premature death and disability globally are due to surgically treatable conditions including obstructed labor and traumatic injuries, human resources and funding for surgical infrastructure lags behind nearly all other public health priorities. The World Health Organization (WHO) and other international health agencies have recently begun to focus on building the tools, protocols and infrastructure to reduce the global burden of surgical disease. Data on the processes and outcomes of surgical care implementation in rural settings of extreme poverty, however, are limited. Here, we propose the first implementation research study to assess the process of scaling up surgical capacity in a rural setting of extreme poverty, the district of Achham, Nepal. Methods and Analysis The study will take place in Achham, Nepal, at a district hospital that is run as a public-private partnership between the Nepali government and the non-profit organization Nyaya Health. Within this region, the study will collect baseline data using community surveillance and referral mechanisms to ascertain the burden of surgical disease in the district. This data will quantify the need for the district hospital to scale up surgical services, as is currently being done based upon the protocols of the WHO’s Integrated Management for Emergency and Essential Surgical Care (IMEESC). The study will assess surgeries across the three venues of surgical care for rural patients in settings of extreme poverty: 1) surgeries conducted on-site by local staff; 2) surgeries conducted on-site by visiting surgical camp teams; 3) surgeries conducted at distant referral sites. Each site will be evaluated for baseline surgical capacity using the Personnel, Infrastructure, Procedures, Equipment, Supplies (PIPES) tool. The analysis for on-site surgeries will focus on cesarean sections and softtissue injuries, since these represent the largest two categories of surgical burden: complicated labor and traumatic injuries. The study will employ both qualitative and quantitative research methodologies to collect clinical data and information on the utilization of services, and to assess process measures at the five key domains of analysis: 1) emergency/pre-operative; 2) operating room/intra-operative; 3) inpatient ward/postoperative; 4) community/follow-up; and 5) facilities and supplies systems. Community health workers (CHWs) will be tasked with ensuring follow-up of all patients. The study will be conducted over the first eighteen months of the implementation process, and will be divided into an initial phase (first six months) and a consolidation phase (subsequent twelve months). Discussion There is an acute need to fill the data gap in assessment of surgeries in rural settings of extreme poverty. In this study, we pilot a model for metric-driven surgical care delivery and assess the feasibility, strengths, weaknesses, and challenges of this approach for implementing and monitoring surgical services. These data can form the basis of larger, multi-site implementation studies with a broader consortium of providers and implementation scientists. Ultimately, data from surgical implementation science studies such as this will provide the framework and evidence base to effectively finance and implement the expansion of surgical services globally. BACKGROUND Worldwide, over 11% of death and disability are attributable to surgically curable diseases. Every year, 234 million major surgeries are performed [1][2][3], yet the distribution of these surgeries is highly inequitable. Approximately 30% of the world’s population receives 74% of the world’s surgical procedures, with the poorest third obtaining a meager 3% [2]. Though limited data exist, it is likely that the mortality and morbidity rates from surgical complications are higher among the global poor [4][5]. Two billion people worldwide, roughly a third of the global population, live in areas with less than one operating room per 100,000 people. As a result, patients in poor countries do not receive timely surgical services and suffer significant morbidity and mortality from preventable and treatable conditions [6][7]. A large global scale-up of surgical capacity is required to close this gap in surgical access. Due to challenges in human resources, transportation systems, and procurement of electricity and water, implementing surgical services in settings of extreme poverty presents unique challenges. A growing literature exists on the deployment of surgical quality initiatives within existing surgical programs, however, data examining how to achieve this on initiation of surgical services is limited [8]. There is thus an acute need to study the core operational processes by which surgical services deployment occurs in remote, resource-limited settings. Furthermore while metrics have been developed for assessing the inputs and outputs of surgical care in urban settings, there are limited data on these metrics in rural settings of extreme poverty [9]. This study will be the first to describe and assess the implementation of surgical services in rural settings of extreme poverty. The approach we take is as follows (see Figure 1). We describe the implementation of World Health Organization's (WHO) Integrated Management of Emergency and Essential Surgical Care (IMEESC) program and develop a metrics system across the three primary venues that rural patients receive care: 1) surgeries conducted on-site by local staff; 2) surgeries conducted on-site by visiting surgical camp teams; 3) surgeries conducted by distant referral sites. In each context, Surgeons OverSeas (SOS) Personnel, Infrastructure, Procedures, Equipment, and Supplies (PIPES) will be used to evaluate baseline surgical capacity and document surgical readiness [21]. The metrics system is built off of WHO’s Safe Surgery Saves Lives initiative developed in urban, specialist centers on statistical metrics for surgery, which focused on the following: number of operating rooms; number of accredited surgeons; number of accredited anesthesia professionals; number of surgical procedures done in an operating room per year; day-of-surgery death ratio; post-operative in-hospital death ratio. These metrics are appropriate and useful in tracking global surgical care, though need to be refined for rural settings of extreme poverty where typically there are only one or at most two operating rooms, a single surgeon and a single nonphysician anesthesia professional [9]. To study this problem scientifically, we will use mixed qualitative and quantitative implementation science methodologies. Implementation science is the study of systems and interventions aimed at establishing and expanding empirically-supported treatments into routine care. We will conduct the research at a district-level hospital in rural Nepal within a district of 270,000 people in a setting of extreme poverty where the nearest reliable, comprehensive surgical services are over 16 hours away. Overview and Specific Aims This study will assess the delivery of surgical care in a rural setting of extreme poverty (Figure 2). Specific Aim 1: Patient-Oriented Characteristics and Outcomes Specific aim 1 is to describe the demographic characteristics and outcomes among surgical patients receiving care in a rural district hospital setting of extreme poverty across the three main categories of surgical delivery: continuous, camp-based, and referral services. To meet specific aim 1, we will collect the following data: geographic distribution, type of surgical disease, time from symptoms to presentation, time from presentation to surgery, successful completion of surgery, complications, and follow-up rates at 72 hours and 30 days. We will also distribute the Surgeons OverSease (SOS) Assessment of Surgical Need (SOSAS) to communities reached through active recruitment methods to better understand the burden of surgical disease within the district. Specific Aim 2: Systems-level Logistical and Clinical Processes Specific aim 2 is to describe the logistical and clinical processes associated with providing and coordinating care in a rural district hospital setting of extreme poverty across the three main categories of surgical delivery: continuous, camp-based, and referral services. To meet specific aim 2, data will include the inputs to surgical care, including: financial, staffing, pharmaceutical, and consumable supply resources. Data will also be collected on the effective implementation of these inputs, including: availability of surgical personnel and facilities, measures of adherence of staff to resuscitation and operating protocols, supply chain reliability, electricity and water reliability, and staff participation in morbidity and mortality conferences and other quality improvement initiatives. We will additionally measure baseline surgical capacity of each site during the implementation phase and additionally throughout the use of each site of the study using the SOS PIPES evaluation tool, an adaptation of the WHO Tool for Situational Analysis of Emergency and Essential Care. PIPES binary system of measurement will make it possible to index changes in surgical capacity as a trend overtime. METHODS AND ANALYSIS Site This intervention will be implemented and tested in the district of Achham, located in Far Western Nepal. Home to approximately 270,000 citizens, Achham is one of the most impoverished regions in South Asia, and provides an excellent research site due to its remoteness, its severe and entrenched poverty, and its weak public sector health system. The study will take place at the district-level Bayalpata Hospital, and follow-up services will utilize its existing community health worker program. Both Bayalpata Hospital and its catchment areas are managed through a public-private-partnership between the nongovernmental organization Nyaya Health and the Nepali Ministry of Health. Study Participants The participants of this research will be patients and their families, as well as hospital staff. The main benefit to research participants will be an improvement in accessibility, quality, and safety of surgical care delivery in their communities. All surgical patients who present to Bayalpata Hospital for continuous, intermittent, and referral services during the study period will be included as participants. The anticipated surgical patients will be predominantly women and children, who represent 75% of all patients served at Bayalpata Hospital. The reason for this demographic predominance is because most of the region’s men travel to India as migrant workers, and are thus absent from the district for large periods of time. Though pediatric patients represent a large portion of the patients seen at Bayalpata Hospital [10], children are less prone to conditions amenable to surgery, and will thus constitute fewer surgical patients. Their involvement in the study, however, will be proportional to the burden of surgical disease among children in Achham. Patients at this facility are all ethnic Nepalis. Owing to the geographically isolated nature of the hospital, it is not feasible for other ethnicities to be part of the service catchment area of Bayalpata Hospital. Hence, this study will be based on the demographics of the region’s residents. Surgical Care Delivery Approach The approach to surgical implementation taken here is based primarily upon the WHO’s IMEESC approach. This strategy will be supplemented with additional community-based follow-up protocols utilizing an existing CHW network, and hospital-based quality improvement mechanisms, one of which is the aforementioned PIPES surgical capacity evaluation tool In this way, it will be possible to provide outreach services to improve patient outcomes, and to establish an ongoing mechanism for institutional change. Such outreach services are critical to continuity-of-care in rural or remote areas with poor transportation infrastructure. The primary clinical manual utilized throughout this process will be the WHO’s Surgical Care at the District Hospital guidelines. Protocols for operations and management policies will include the WHO’s Best Practice Protocols: Clinical Safety Procedures, as well as emergency and surgical care protocols for physicians and nurses developed in collaboration with the authors. Utilizing these foundations, this implementation includes 1) the core IMEESC surgical care program, 2) community-based follow-up via CHWs, and 3) tracking system for all surgical patients. Recruitment For this specific study, we plan to collect active community-side surveillance of the surgical disease burden for both planning and detection purposes. While a passive approach, which will stem mainly from contact with both community health workers and hospital-based staff, will also serve as a basis for surgical detection, active recruitment through referral tools, such as public radio, will also be used. A patient screening protocol has already been initiated, in which patients that present to Bayalpata Hospital’s emergency and outpatient departments with surgically treatable illnesses are documented and referred to either the Bayalpata Hospital surgical program or a higher referral center. There is a clear need for emergency surgical services due to the lack of such services in the region, although data regarding the extent to which it is needed has not been ascertained. Given that Bayalpata Hospital serves a dispersed catchment area of up to 500,000 people in a travel radius of over 24 hours, a community survey may be difficult to distribute. However, through developed referral mechanisms that will look to foster community outreach to all residents, the survey we propose to use will be able to adequately predict the surgical volume within the district. Furthermore, we believe that understanding the burden of surgical disease presenting for medical services provides important data that may aid health ministries, hospitals, and nongovernmental organizations seeking to roll out surgical services in resource limited settings. Local Continuous Services Bayalpata Hospital currently has the capacity to conduct only minor surgical procedures, and the upcoming expanded services will include procedures described in Table 1. During the implementation phase, PIPES will be used to evaluate the baseline surgical capacity at Bayalpata Hospital, which will help identify needs and plan for increases in surgery. Over time, PIPES index will be calculated, allowing us to examine the change in capacity overtime [21]. All of these procedures will be performed by a generalist physician with post-graduate surgical training (referred to as an “MD-GP” in Nepal). This type of practitioner is the government of Nepal's focus for physician human resources for essential surgical care in rural areas. Surgical aspects of MDGP training focus specifically on the surgical procedures outlined in Table 1, and competency in these procedures is required for graduation. The level of training analogous to that of MD-GP practitioners is also the focus of the IMEESC program worldwide. The surgeon will receive additional on-site support and training via visiting senior surgeons from among Nyaya Health colleagues in the United States and Nepal. Utilizing Nyaya Health’s existing Mortality and Morbidity programhttp://wizfolio.com/?citation=1&ver=3&ItemID=205&UserID=13252&AccessCode=7EE7EAB8 AC3A4DD980B1E07EFC4BD0A8&CitationSuffix=, email discussion and support will also be available to the surgical staff on a non-urgent basis. This program is intended to enable enhanced learning and reflection, rather than to provide active, real-time management. The MD-GP will oversee an Anesthesia Assistant trained within the government’s scheme to deliver basic anesthesia care to surgical patients in rural areas. A Staff Nurse (a specific designation within the government of Nepal’s healthcare provider hierarchy) will assist the MD-GP and Anesthesia Assistant in providing postoperative care. In keeping with current policy, any cases that are outside the scope of practice of this modest team will be sent via ambulance to an appropriate referral center (between 6 and 14 hours away). Local Intermittent Surgeries (Surgical Camps) The first phase of surgical services will be initiated with a series of surgical camps, which are anticipated to include treatment of surgical conditions within the categories detailed in Table 1. Each will be evaluated using PIPES during implementation. These camps will serve not only to provide surgical treatment to patients within Bayalpata Hospital’s catchment area, but also to provide continuing medical education for Bayalpata Hospital’s surgical staff members. All patients receiving treatment during surgical camps will be followed-up by members of the Bayalpata Hospital CHW network. Referral Surgeries Patients identified through active and passive screening and who cannot be treated via local continuous or intermittent camp services will be referred to higher centers for care. Patients who meet criteria for enrollment into a crowdsource funding intervention in partnership with the international non-profit Watsi will have their transportation and surgical fees paid for. Those who are not eligible for the Watsi program will be referred as per typical practice. Patients who present to Bayalpata Hospital with surgically-treatable illnesses that they cannot personally fund may be selected as Watsi cases. Watsi provides an online interface through which donors can directly contribute funding for patient surgeries, and has to-date funded numerous life-changing procedures for patients from Achham and elsewhere. Please see Appendix 1 for the Watsi patient referral protocol and details. Follow-up The existing network of CHWs at Bayalpata Hospital will follow-up with post-surgical patients to detect and prevent complications [7]. Within each political subdivision, these health workers report to community health advocates, who in turn report to hospital-based coordinators. This network was built off of the government of Nepal’s existing health worker infrastructure. As such, this model should be scalable both within Nepal and in the many countries that have government-sponsored CHW networks. Quality Improvement The implementation of surgical services will occur within the framework of quality management using PlanDo-Study-Act and Root Cause Analysis models. Methods will include regular data management reviews, clinical- and operational-level checklists, and a mortality and morbidity conference program. We anticipate that these will evolve over the course of the study, as with any quality improvement initiative. Bayalpata Hospital maintains an active database of administrative and clinical data that integrates outcomes for its clinical programs. In addition, quality checklists will serve as the basis for ongoing improvement, including materials management, facilities maintenance, biomedical engineering, and provider-level clinical care. Finally, an ongoing mortality and morbidity review program conducted at the hospital will serve as an institutional quality improvement mechanism. The overall program aims to identify and address challenges and action items in the spectrum of structure, process, and outcomes. Metrics and Analysis An implementation science approach will be used to study the deployment of surgical services in this rural, resource-limited setting. This study will follow the first 18 months of the implementation process. Since effective implementation hinges on quantifiable systems and human implementation as well as the reception of such systems, a mixed qualitative and quantitative research methodology will be employed. Both approaches are crucial, and will be used in a complimentary fashion to collect data and identify key drivers for implementation elsewhere. Given that some changes are anticipated during the initial scale-up process, the analysis will be broken down into an initial phase (first six months) and a consolidation phase (subsequent twelve months. Specific Aim 1 Nature of Surgical Disease Presenting at Bayalpata Hospital This study will quantify the type of surgical diseases present and the treatment of these diseases using a simple data recording instrument (draft attached). Data will be displayed in two forms: (1) a tabular form with demographic and descriptive information, and (2) a summary form, in which information will be categorized by types of conditions present during the initial and consolidation phases. We hypothesize that there will be a gradual expansion over time of more complex diagnoses and surgical procedures, which can be reflected in PIPES periodic evaluations of baseline surgical capacity. We expect that this expansion will occur rapidly during the first 6 months and hit a plateau by 18 months. This hypothesis predicts that by the end of the studied 18 months, the annual number of surgeries will approach 20 per 10,000 citizens. Community-Based Follow-Up The rate of patient improvement will be assessed by CHW patient follow-up 72 hours after surgery and again 3 weeks following discharge from the hospital using formatted checklist documents and consistent data collection techniques. CHWs will be provided with structured training and hospital staff support, as currently occurs within the Bayalpata CHW program [11]. Follow-up in rural Nepal is complicated by the severe lack of effective transportation infrastructure. Furthermore, given the dearth of services in the area, it is expected that patients will be travelling long distances to reach the hospital. In the first three months of implementation of X-Ray services at Bayalpata Hospital, for example, 20% of patients travelled, typically by foot, more than 10 hours each way to access services [12]. Despite these challenges, based on existing experience at the hospital, we hypothesize that this program will be able to provide follow-up services to 95% of patients throughout the study period. Complication Rates Major complication rates form the basis of any surgical services monitoring and evaluation program, yet the time course of how frequently they occur in resource-limited settings has yet to be studied. Immediate postsurgical clinical complications will be tracked as per Table 2. These data will be interpreted in light of the qualitative analysis of Bayalpata Hospital’s existing mortality and morbidity review program and quantitative data analysis of trends and frequency of post-operative occurrences. Specific Aim 2 Staffing We will describe the hiring and presence of staff, including qualifications, role, and days present on the job. Financial Inputs All raw financial inputs into the system will be quantified and broken down into categories for pharmaceuticals, capital equipment, consumables, and facilities construction and maintenance inputs. These inputs will be obtained by monthly analyses of the financial databases currently in existence at Bayalpata Hospital. Costs will include pharmaceutical facility staffing [13], consumable materials, and capital equipment; total monthly costs will be displayed in a histogram. Within each bar in the histogram, the percentage of the total costs for each category of expenditures will also be displayed. Based on Bayalpata Hospital’s costing model (available for download via references [14] and [15]), we hypothesize that the overall construction and two-year operating costs of implementing the IMEESC-Plus model will be $0.50 USD per capita in the district. The study will tag all costs for each component of the interventions and calculate marginal cost effectiveness for each of the primary and secondary outcomes, using pre and post intervention data. All costs will be assessed in 2013 United States dollars and inflation-adjusted. Cost effectiveness will be calculated per surgery and per day of operating room availability. Pharmaceutical and Consumable Item Utilization The usage of pharmaceutical and consumable items during the roll-out process will be tabulated based upon monthly analyses of the pharmaceutical and supply databases currently in existence at Bayalpata Hospital. Assessment will be based primarily on high-volume items, including antibiotics, suture material, scalpels, and needles. Monthly utilization patterns will be displayed by means of a histogram. Stocking Protocols Staff compliance to stocking protocols will be assessed by adapting existing WHO site analysis tools, and will be displayed via monthly histograms. It is hypothesized that there will be a steady compliance to pharmaceutical and consumable stocking protocols, with no greater than 5% missing items on a monthly basis. Surgical Safety and Resuscitation Protocols Assessments will be made for adherence to the Surgical Safety Checklist, as well as novel emergency resuscitation (pre- and post-surgical care) and hospital operations protocols developed for this project [16]. The surgical safety checklist to be employed is well-validated and described, and has been adopted by the WHO as the standard for surgical services globally. However, the real-world functioning of this checklist at the outset of services in severely resource-limited settings has yet to be described (see Appendix 2 for checklist structure). The analysis of surgical checklist adherence will occur as per Table 2. Staff adherence to other care protocols will be determined by evaluation forms that have been adapted from the WHO model to evaluate nursing and physician performance (see Appendix 3). Qualitative Documentation of the Implementation Process The deployment process will be documented qualitatively, with the primary domains of analysis being the following: human resource management, supply chains, in-hospital work flows, and patient-level interactions. Hospital-level analyses will be performed according to three modalities: (1) open-ended, semi-structured interviews of staff at three-month intervals, (2) non-participant observation of planning meetings and morbidity and mortality conferences, and (3) focus groups with staff at three-month intervals (see Appendix 4) [17]. All interviews and observations will be recorded in a journal maintained by the research coordinator. This journal will then be translated and back-translated, and assessed using the framework analysis methodology [18]. Comparative Cost Effectiveness Analysis In addition to analyzing the financial inputs involved in the initial surgical scale-up process, the financial inputs per surgical patient will be documented and presented. To accomplish this, post-scale-up financial inputs per patient will be tabulated and compared to the average costs per surgical patient referred prior to the availability of surgical services at Bayalpata Hospital. In the years preceding commencement of surgical services in Achham, all patients in need of surgical services were referred to other hospitals, ranging from 236 hours of travel away. Most of these surgical referral centers operate on a fee-for-service basis, and thus present significant costs for surgical patients (see Table 3). By analyzing the average patient costs associated with commonly-referred conditions, and comparing them to the costs per patient of providing the same services at Bayalpata Hospital, the decrease in financial impact on the surrounding communities will be assessed. For non-emergent surgeries that are conducted via surgical camps and Watsi referrals, disability adjusted life years (DALYs) averted per patient will be calculated and compared to the costs per surgical patient accrued. All costs will be assessed in 2013 United States dollars and inflation-adjusted. Cost effectiveness will be calculated per surgery and per day of operating room availability. Sample Size Considerations Specific Aim 1 Our primary outcome for this analysis will be the rate of major complications (including death, as per Table 2) within the first 72 hours following surgery. Patients who are lost to follow-up will be considered treatment failures, both programmatically within Bayalpata Hospital and from a research/evaluation standpoint within the context of the study. Patients and their families may, and in our experiences oftentimes do, leave earlier than the treatment team may suggest. However, even in these instances, we should be able to track down patients in their home communities. Both programmatically and scientifically, we feel that it is important to document longer-term follow-up than typical surgical care programs provide. A secondary outcome will be the rate of major complications prior to leaving the hospital. With 100 patients in the initial period, it will be possible to estimate the true complication rate within a +/10% interval with 95% certainty. For example, if 5 out of 100 (5%) patients have a complication in the initial period, then the 95% exact binomial confidence interval will be approximately [1.6%,11.3%), with a width of 9.7%. With 400 patients in the consolidation period, it will be possible to estimate the true complication rate within a +/-5% interval with 95% certainty. For example, if 20 out of 400 (5%) patients have a complication, then the 95% exact binomial confidence interval will be approximately [3.1%,7.6%), with a width of 4.5%. In this pilot phase, the complication rates during the initial and consolidation phases will not be directly compared. The complication rates are expected to be too small to fit a multiple logistic regression model to determine important predictors. However, with twenty complications in the consolidation phase, it would be possible to fit logistic regression models with each covariate separately. Specific Aim 2 The rates of adherence to each protocol are estimated for the initial 6 months and the subsequent 12 consolidation months. With 100 patients in the initial period, it will be possible to estimate the true complication rate for a given process measure within (at most) a +/-10% interval with 95% certainty. For example, for a given process measure, if the process measure is followed in 80 out of 100 (80%) patients in the initial period, then the 95% exact binomial confidence interval will be approximately [71%,87%), with a width of 16%. With 400 patients in the consolidation period, it will be possible to estimate the true complication rate for a given process measure within a +/-5% interval with 95% certainty. For example, for a given process measure, if the process measure is followed in 380 out of 400 (95%) patients, then the 95% exact binomial confidence interval will be approximately [92%,97%), with a width of 5%. In this pilot phase, the adherence rates during the initial and consolidation phases will not be directly compared. Secondary logistic regression analyses will be performed to determine important predictors of complication, including acuity of admission (elective, emergency), surgery type (orthopedic, plastic, obstetric, intra-abdominal), length and time of operation, wound classification, and American Society of Anesthesiologists (ASA) risk index classification. Ethics and Dissemination In this assessment of a surgical services intervention, the primary risk to subjects is the leaking of protected health information. The surgical services that patients receive are part of the standard of care practices at Bayalpata Hospital and are not research-related. Ensuring the privacy and anonymity of patient information is essential, and measures will be employed in accordance with Health Insurance Portability and Accountability Act [19] (HIPAA) guidelines to ensure patient confidentiality. Such measures will include careful de-identification of patient records, use of secure servers, password-protected databases, and physical locking of medical record storage in the clinic. No protected health information will be recorded or transmitted electronically. Bayalpata Hospital staff members have extensive experience in ensuring the safety of protected health information through an ongoing data management program. An additional risk is that of psychological harm to patients who are interviewed following surgery. This will be minimized by having sensitivity training for all staff members and by using standardized instruments. Staff debriefing will also be conducted to identify challenges and encourage open discussion for support and resolution. Ethics review board proposals will be submitted to the Brigham and Women’s Hospital and to the Nepal Health Research Council prior to starting the study. All de-identified data, protocols, and documentation from the study will be made openly accessible to the public and disseminated via a public-access website [20]. DISCUSSION This prospective study will be the first to describe and assess the need for and implementation of surgical services in a setting of extreme poverty. By tracking patients within the three primary categories of rural surgical provision: 1) continuous, 2) intermittent, and 3) referral, we can start to develop an implementation science approach for the development and scale-up of rural surgical care. The primary limitation of this research is that it is a single-facility study. Biases can be seen when studying the effects of a single hospital or surgeon. It is anticipated, however, that the in-depth analysis of the process and logistics of surgical scale-up implementation will form the necessary groundwork for a larger multi-site study. Furthermore, the implementation of surgical services requires a broad-based team approach, and this study will examine the entire trauma and surgical system. This system, while dependent upon individual providers, must contain set protocols that operate effectively despite strengths and weaknesses of any given clinician. The longitudinal data on implementation process costs, safety, and utilities that this study will provide are not yet available. Once determined, however, these data will provide basic parameters for designing a larger implementation research study. TABLES AND FIGURES Figure 1: Metric-driven Surgical Care Delivery for Rural Settings of Extreme Poverty Delivery: IMEESC core surgical care program across continuous, camp, referral services Quality Improvement: Use of tracking system, metrics to improve quality Follow-up: Community-based follow-up via health workers Figure 2: Study Overview STUDY OVERVIEW Logistical Processes Flow of Patients All Surgical Patients Passive Detection (Hospital) Passive Detection (CHWs) Active Detection (CHWs) Patient Evaluation by Clinical Team On-site Treatment Off-site Treatment Continuous Watsi Services Referral Intermittent Non-Watsi Services Referral Inputs to surgical care -Financial inputs -Staffing processes -Pharmaceutical supplies -Consumable supplies Availability of surgical personnel and facilities Staff adherence to: -Resuscitation protocols -Operating protocols Supply chain reliability Electricity and water reliability Staff participation in: -Morbidity and mortality conferences -Quality improvement initiatives Patient-Oriented Processes Geographic distribution Type of surgical disease Time from symptoms to presentation Time from presentation to surgery Successful completion of surgery Complications Follow-up rates Table 1: List of essential surgical services provided during study period On-Site Services (Continuously Available) Amputation of Digits Casting/Splinting Cesarean Section Debridement Dressing/Irrigation Excision/Lumpectomy Foreign Body Removal Herniotomy/Hernioplasty Hydrocele Reduction Incision & Drainage Laceration Repair Lipoma Excision Tubectomy Vasectomy Surgical Camp Services (Intermittently Available) Amputation of Limbs Appendectomy Cholecystectomy Circumcision Hysterectomy Internal Fixation Internal Open Reduction Laparotomy Mastoidectomy Myringoplasty Referral Services (Available Outside District) All other surgical cases, notably: Cardiac surgery Thoracic surgery Plastic Surgery Complex intraabdominal surgery Pediatric surgery Table 2: Metrics for Local (Continuous and Intermittent) Services Outcomes Measures for Surgical Implementation Process Measures Community Demand, Surveillance, and Epidemiology Geospatial mapping of cases Demographic description of cases Hours to reach hospital from home Time from first symptoms to presentation Type of surgery required Facilities and Supplies Systems X-ray machine in working order, with technician to operate it Electricity present throughout duration of surgery Number of days that the surgical theater is open^ Number of days that at least one surgeon is present Number of days that at least one anesthesia professional is present Suction machine verified and working pre-operatively Oxygen source verified and working pre-operatively Documentation of appropriate temperature strip from autoclave of surgical instruments Emergency Room/Pre-Op Fetal heart rate documented Indication documented Time from decision to incision Pre-operative evaluation and documentation of airway Pre-op hematocrit documented Operating Room/Intra-Op Time out performed prior to surgery Pulse oximeter working throughout the case Appropriate perioperative antibiotic use* Appropriate size suture documented Estimated blood loss documented Intra-op fluids given documented Urine output documented Blood transfusion needed Inpatient Unit/Post-op Vital signs recorded within 30 minutes post-op Postoperative exam documented by nurse within 30 minutes Pain assessment documented immediately post-op Length of stay in inpatient surgical ward Length of time until ambulation Length of time until regular diet/ oral pain meds Community/Follow-up Use of ambulance Paid community health worker available in patient’s ward Number of deliveries at hospital, cesarean and non-cesarean Successful follow-up by community health worker within 72 hours Successful follow-up by community health worker at 30 days Outcomes Measures# Mortality and major complications Neonatal mortality Wound dehiscence Wound infection *Assessed as whether or not the correct drug and dose, non-expired, was administered based upon the protocol for each surgery. ^Closures may be due to staffing shortages (including absences owing to trainings), supply chain, electricity issues #Standard maternal and surgical morbidity and mortality, as per Table 2 obstetrics and soft tissue injury indicate scenarios in which the metric is only applicable to those particular surgeries Table 3: Comparative Cost Effectiveness Analysis Metrics EMERGENT PATIENT METRICS Pre-Implementation Post-Implementation (Costs borne by patient) (Costs borne by BH) - Transportation - Consumables - Lodging - Staffing - Surgical Procedure - Medications - Inpatient Stay - Medications - Follow-up Care NON-EMERGENT PATIENT METRICS Cost per Patient - Consumables - Staffing - Medications DALYs Averted -Qualitative determination of years of disability averted Appendix 1: Watsi Protocol Identification of patients This protocol outlines the policies regarding identification, evaluation, and treatment of patients that can receive free care via Nyaya Health’s program with WATSI. In this program, patient profiles are posted online with the hopes to inspire donors to fund for individual patient’s treatment. Identification of Cases Any condition that has a significant impact on a patient’s life and has a strong possibility of cure or otherwise improvement with a discrete intervention. rheumatic heart disease congenital heart disease hydrocephalus fractures contractures burns club foot cleft palate locally resectable cancer or cancer otherwise with a reasonable hope of cure cholecystectomy hernia repair hydrocele repair insulin dependent diabetes **Please note that most of these are surgical; we have added insulin-dependent diabetes as one medical lifethreatening disease for which insulin is life-saving in the medium-term. Cases should be emailed to [email protected] at any and all junctures. The team of clinicians can quickly address any clinical questions or concerns. Photography and Story On identification of these conditions, please notify the individual within the Community Health department who serves as the Watsi Coordinator. He/She will then take consent, a high-resolution photograph, and story from the patient. These should be saved to dropbox Development\Dev - Partnerships (Private)\Watsi\Patient Profiles. Referral for Diagnostics and Evaluation In many cases, there will be up-front costs for diagnostics and evaluation. If there is a reasonable likelihood that the patient will require intervention, then Nyaya Health can pay for the travel and evaluation. The initial evaluation usually will take place at Nepalgunj Medical College. These costs will be eventually paid for through WATSI as reimbursement once the funds are raised through the website. The contact information is provided below. Referral for Treatment Referral contact shall be made with an existing known excellent provider and partner of the intervention. We maintain a list of contacts below. We should work to minimize unnecessary travel and work with surgeons to plan ahead of time and book operating room time in advance of the patient’s visit. Principles of Payments for Diagnostics and Treatment We should NOT be giving money directly to the patients. There should be no possibility of our donations being abused. For the most part, stable patients will be transported by bus. Bus tickets may be purchased and provided to the patient. For diagnostics at Nepalgunj Medical College, patients will carry with them a note stating that payments be billed to Bayalpata Hospital. These will then be paid by direct transfer from Bayalpata Hospital accounts. For room and board, we will try to arrange for agreements locally that we can likewise pay directly. Responsibilities of Watsi Coordinator Check in regularly with doctors and health assistants regarding potential cases. Maintain at least ten print-outs of the consent form to be ready to obtain consent at any moment Provide consent to patient and maintain in Watsi program file Take high resolution picture of patient, type “watsi on boarding” response for the patient, and save to dropbox Development\Dev - Partnerships (Private)\Watsi\Patient Profiles Look up in “Nepalgunj costing sheet” the approximate price of the intervention. This is found in dropbox Development\Dev - Partnerships (Private)\Watsi\Referral Costing Sheets Coordinate with Nepalgunj Medical College and Nepalgunj Rotary Club for following up on patients and getting diagnostics Coordinate with treating institution for timings Responsibilities of Health Assistants and Doctors The primary role of the HAs and doctors is to identify cases and provide all the clinical information to the Watsi Coordinator. Also, they should assist with any contacts they have at any of the referral hospitals and with follow-up of patients during the evaluation period and following treatment. We would like the same HA to see their follow-up patients at every visit. This continuity in care is very important to ensure quality care for our patients. Potential challenges and tips for Watsi Coordinator Identifying cases be an advocate for the program; keep asking any of the health assistants Getting timely responses from referral hospitals go to the top grade person known at the facility first and then say their name at all lower level communications if you are having trouble owing to gender bias, discrimination, or perception you are too “junior”, have a senior physician or administrator call on your behalf Ask that senior leadership, whenever they are in the vicinity of referral hospitals, sign MOUs and otherwise meet with leadership of the hospital. Example MOUs are found in dropbox for Dhulikhel and Nepalgunj Medical College. Always prepare the MOU ready for signature prior to meeting (Obstetrics) Caesarian Delivery Indication (d) Surgical Disease (c) Tertiary Comorbidity (ICD) Secondary Comorbidity (ICD) Primary Comorbidity (ICD) Location (b) Chief Complaint(a) Contact Information Time Date IP Number Appendix 2. Surgical Implementation Checklist and Coding Chart VITAL SIGNS Preoperative HR Postoperative HR 1hr Postoperative HR 2hr Postoperative HR 3hr Postoperative HR B/P B/P B/P B/P B/P Resp. Resp. Resp. Resp. Resp. O2 Sat. O2 Sat. O2 Sat. O2 Sat. O2 Sat. Temp. Temp. Temp. Temp. Temp. Pain Pain Pain Pain Pain HISTORY Past Medical History:_____________________________________________________________ Past Surgical History:_____________________________________________________________ Past Obstetric History: G____ P____ Past Obstetric Complications:________________________ Current Medications:____________________________________ Allergies:_________________ Onset of Symptoms:_________Hours/Days/Weeks (circle one) prior to presentation Hours Traveled to Reach Hospital___________________________________________________ Referral from (circle): [1]None [2]Subhealth Post [3]Health Post [4]Nepalgunj [5]Kathmandu [6]India PREOPERATIVE Autoclave temperature documented Yes No Temp: Fetal heart rate documented (obstetrics only) Yes No HR: Preoperative airway documentation Yes No Difficult Airway: Yes/No Preoperative hematocrit documentation Yes No Hct: Time out performed prior to surgery Yes No Time from diagnosis to incision Diagnosis: Incision: Pre-operative Notes INTRAOPERATIVE Intra-op Fluids Given Urine Output Documented Blood Transfusion Needed POST-OPERATIVE Perioperative Antibiotic Given Suture Size Documented Post-Operative Fluids Given Urine Output Documented Blood Transfusion Necessary Yes Yes Yes No No No Amount: Amount: Amount: Yes Yes Yes Yes Yes No No No No No Name: Size: Amount: Amount: Blood Type: Amount: Amount: a. Chief Complaint 1. Pain 2. Swelling 3. Mass 4. Bleeding 5. Penetrating Trauma 6. Blunt Trauma 7. Shortness of Breath 8. Caesarian Delivery 9. Other b. Location 1. Head 2. Face 3. Neck 4. Upper Extremity 5. Chest 6. Abdomen 7. Pelvis 8. Spine/Back 9. Lower Extremity h. Medical Complication 1. Cardiac Arrest 2. DVT 3. Pneumonia 4. Pulmonary Embolism 5. Sepsis 6. Septic Shock 7. Surgical Site Infection 8. UTI 9. Anesthesia Complication 10. Excessive Bleeding 11. Hypotension 12. Hypertension 13. Other c. Surgical Disease 12. Fracture: Open Displaced 13. Fracture: Open Non-Displaced 14. Fracture: Closed Displaced 15. Fracture: Closed Non-Displaced 16. Gangrene 17. Goiter 18. Hernia 19. Hydrocele 20. Laceration 21. Mass/Tumor 22. Ovarian Torsion e. Interventions 1. Foreign Body Removal 12. Cholecystectomy 2. Dressing/Irrigation 13. Internal Fixation 3. Casting/Splinting 14. Internal Open Reduction 4. Laceration Repair 15. Myringoplasty 5. Incision & Drainage 16. Mastoidectomy 6. Debridement 17. Herniotomy/Hernioplasty 7. Excision/Lumpectomy 18. Hysterectomy 8. Cesarean Section 19. Tubectomy 9. Laparotomy 20. Vasectomy 10. Amputation 21. Circumcision 11. Appendectomy 22. Other i. Infrastructure Complication 1. Lack of Electricity 9. Oxygen Source Not Functioning 2. Lack of Water 10. Autoclave Not Functioning 3. Surgeon Absent 11. Pulse Oximeter Not 4. Anesthesia Staff Absent Functioning 5. Nursing Staff Absent 12. Blood Unavailable for 6. X-ray Staff Absent Transfusion 7. X-ray Not Functioning 13. Instruments Unavailable 8. Suction Device Not 14. Medications Unavailable Functioning 14. Other FCVH Referral (Yes/No) 3rd F/U Outcome (g) 3rd F/U (# days) 2nd F/U Outcome (g) 2nd F/U (# days) 1st F/U Outcome (g) 1st F/U (# days) 1. Abscess 2. Appendicitis 3. Burn 4. Cataract 5. Cholecystitis 6. Chronic Osteomyelitis 7. Cleft Lip 8. Club Foot 9. CSOM 10. Dental Abscess 11. Foreign Body d. Caesarian Delivery Indication 1. Abnormal 11. Pre-eclampsia Presentation 12. Eclampsia 2. Dystocia 13. Infection 3. Placental Abnormality 14. Multiple Births 4. Fetal Distress 15. Maternal HIV 5. Obstruction 16. Maternal STI 6. Pelvic Abnormality 17. Uterine Rupture 7. Acidemia 18. Previous Delivery 8. Cord Prolapse Complications 9. Maternal Tachycardia 19. Elective Caesarian Delivery 10. Fetal Tachycardia 20. Other g. Disposition 1. Home: Recovered 2. Home: Not Improved 3. LAMA 4. Absconded 5. Referral 6. Dead: Within 48H 7. Dead: After 48H # of Inpatient Days Referral (j) Infrastructure Complication (i) Medical Complication (h) Outcome (g) Anesthesia Type (f) Intervention (e) Post-Operative Notes 23. Peritonitis 24. Phimosis 25. Paraphimosis 26. Pregnancy (C/S) 27. Rectal Prolapse 28. Testicular Torsion 29. Trauma 30.Ulcer 31. Uterine Prolapse 32. Other f. Anesthesia Type 1. None 2. Local 3. Regional Block 4. General Sedation/Analgesia 5. Ketamine 6. General Anaesthesia j. Referral From/To 1. None 2. Subhealth Post 3. Health Post 4. Nepalgunj 5. Kathmandu 6. India Appendix 3. Systems Checklist SURGICAL SYSTEMS CHECKLIST Week of______________________________ FACILITIES METRICS Electricity outage for >30 minutes in past 24 hr.? Water shortage for >30 minutes in past 24 hr.? X-ray machine functioning for past 24 hours? CLINICAL METRICS Staff adherence to operating protocols? MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY SUNDAY Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY SUNDAY Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Blood available for transfusions? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Surgeon available for the past 24 hours? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Autoclave dysfunctional for >30 minutes in the past 24 hr.? Oxygen cylinders present in ER and at least 50% full? Anesthesia Assistant available for the past 24 hours? At least one surgical nurse available for the past 24 hours? X-ray technician available for the past 24 hours? Suction device functioning for the past 24 hours? Patient monitors functioning for the past 24 hours? Surgical instruments available for the past 24 hours? Surgical medications available for the past 24 hours? Appendix 4. Focus Group and Individual Interviews on Quality and Patient Safety Culture Patient safety culture is a set a values about how individuals behave and what attitudes are appropriate to ensure patient safety. Safety culture within a healthcare organization can be qualitatively measured with interviews and focus groups. Interviewers will work to understand the dynamics of the way people interact and make decisions about surgical safety. Rather than evaluating what interviewees think ought to be done, these focus groups will examine the shared set of ideas reflected in current practice. There are several issues to consider for patient safety culture and the team dynamics within the healthcare setting. Patient safety involves quality improvement of current practices and thus is promoted by positive attitudes towards innovation and risk taking. Assessments should address whether the organization encourages new ways of doing things, or instead values traditional approaches. Team dynamics is tied with patterns of communication. For example, participants should be asked about the degree to which communication and reporting are restricted to formal hierarchies of authority versus informal channels. Outcome or process orientation, or whether control and reward are focused on tasks and processes compared with the end products and results, is also an important element of the culture and dynamics of the group. Questions and discussions should also address whether the organization encourages and rewards individualism, or fosters and values close teamwork. Topics to focus on for interviews: - Overall perceptions of safety - Frequency of events reported - Supervisor/manager expectations and actions promoting safety - Teamwork within hospital - Feedback and communication about errors Questions to ask for interviews and focus groups: - Is patient safety ever put at risk to get more work done? - Are there procedures for preventing errors from happening? - What safety issues have come up in the past? - Does your supervisor/manager seriously consider suggestions for improving patient safety? - What are you actively doing to improve patient safety? - Have mistakes led to positive changes around here? - What do you do to evaluate the effectiveness of changes? - Do people help each other out? For example, when one area of the hospital becomes very busy? - Do you know how to report patient safety issues? - How often do you speak up regarding issues endangering patient safety? - Do you feel comfortable raising concerns to supervisors/managers regarding their decisions? - Do you feel like your mistakes will be held against you? Appendix 5. Referred Patient Follow-Up Form REFERRED PATIENT FOLLOW-UP Dates Successfully Contacted:______________ Dates Unsuccessfully Contacted:_______________ Date Evaluated by Referral Doctor:_____________________________________________________ Intervention:________________________________________________________________________ Type: Diagnostic Only Surgical Intervention Nonsurgical Intervention Date of First Intervention ________________ Date of Discharge ____________________________ Outcome: Recovered/Improved Not Recovered Dead Unreachable Complications: Time after Intervention Patient Reevaluated by Doctor:_____ Hours Appendix 6. Watsi Patient Follow-Up Form WATSI PATIENT FOLLOW-UP Dates Successfully Contacted:_________________ In-Person Phone Other _____________ Dates Unsuccessfully Contacted:_______________ In-Person Phone Other _____________ Dates Evaluated by Referral Doctor:______________________________________________________ Interventions:_________________________________________________________________________ Type: Diagnostic Only Surgical Intervention Nonsurgical Intervention Days in Hospital (Non-ICU):__________________ Days in Hospital (ICU):____________________ Date of First Intervention:_____________________ Date of Discharge:_________________________ Total Days away from Home District: ____________________________________________________ Outcome at 3 days: Recovered/Improved Not Recovered Dead Unreachable Complications (see codes below):_____________________________________________________________ Outcome at 30 Days:___________________________________________________________________ Complications:________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ Time after Intervention Patient Reevaluated by Doctor:_____ Hours COMPLICATION CODES h. Medical Complication 1. Cardiac Arrest 2. DVT 3. Pneumonia 4. Pulmonary Embolism 5. Sepsis 6. Septic Shock 7. Surgical Site Infection 8. UTI 9. Anesthesia Complication 10. Excessive Bleeding 11. Hypotension 12. Hypertension 13. Other i. Infrastructure Complication 1. Lack of Electricity 9. Oxygen Source Not Functioning 2. Lack of Water 10. Autoclave Not Functioning 3. Surgeon Absent 11. Pulse Oximeter Not Functioning 4. Anesthesia Staff Absent 12. Blood Unavailable for Transfusion 5. Nursing Staff Absent 13. Instruments Unavailable 6. X-ray Staff Absent 14. Medications Unavailable 7. X-ray Not Functioning 14. Other 8. Suction Device Not Functioning Appendix 7. Surgeons OverSeas PIPES Surgical Assessment REFERENCES 1. Haynes, A.B., et al., A surgical safety checklist to reduce morbidity and mortality in a global population. The New England journal of medicine, 2009. 360(5): p. 491-9. 2. 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