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S U R G E RY I N L O W A N D M I D D L E I N C O M E CO U N T R I E S
Implementation Analysis of a Perioperative Patient Safety
Program in Guatemala
Isabelle P. Sico 1 •^ Bria J. Hall 1 •^ Angie Aguilar-Gonza´lez 2 •^ Monica Orozco 3 •^ Carla Ramirez 4 • Joy Noel Baumgartner 1 •^ David Boyd 1 •^ Javier Bolan˜ os 4 •^ Erwin Calgua 3 •^ Randall Lou-Meda 2 • Henry E. Rice 1,
Ó Socie´te´ Internationale de Chirurgie 2020
Abstract Background The implementation of programs to improve patient safety remains challenging in low- and middle- income countries. The goal of our study was to define the barriers and facilitators to implementation of a periop- erative patient safety program in Guatemala. Material and methods We conducted semi-structured interviews with 16 staff pre-intervention and a follow-up focus group discussion 1 year later in the perioperative department at the Roosevelt Hospital in Guatemala. We performed qualitative thematic analysis to identify barriers and facilitators to the implementation process, with analysis guided by the Consolidated Framework for Implementation Research. Results We found several dominant themes affecting implementation of a patient safety program. Implementation facilitators included strong prioritization of patient needs, program compatibility with existing workflow, and staff attributes. Barriers included a lack of knowledge about patient safety, limited resources, limited leadership engagement, and lack of formal implementation leaders. Several program modifications were made to enhance successful implementation iteratively during the implementation process. Discussion Our analysis highlights several dominant themes which affect the implementation of a perioperative safety program in Guatemala. Understanding the barriers and facilitators to implementation during program deployment allows for program modification and improvement of the implementation process itself.
Introduction
The reduction in medical errors is essential to improve patient care, especially in high-risk perioperative environ- ments. Perioperative care is particularly hazardous in low- and middle-income countries (LMICs), where the rate of medical errors far exceeds those in high-income countries [1]. Efforts to improve perioperative care have driven the use of pre-procedural checklists and process standardiza- tion programs [2]. However, these programs remain diffi- cult to implement in LMICs [3]. Implementation analysis can help understand factors which impact the adoption of new health-care practices [4]. By analyzing factors that affect the implementation pro- cess, any barriers or facilitators to adoption of new prac- tices can be identified and addressed early in program
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00268-020-05495-1) contains sup- plementary material, which is available to authorized users.
& Henry E. Rice rice0017@mc.duke.edu
(^1) Duke Global Health Institute, Durham, NC, USA
(^2) Pediatric Nephrology Unit FUNDANIER, Roosevelt
Hospital, Guatemala City, Guatemala (^3) Facultad de Ciencias Me´dicas, Universidad de San Carlos de
Guatemala, Guatemala City, Guatemala (^4) Pediatric Surgery Department, Roosevelt Hospital,
Guatemala City, Guatemala (^5) Division of Pediatric Surgery, Duke University Medical
Center, Box 3815, Durham, NC 27710, USA
https://doi.org/10.1007/s00268-020-05495-
implementation. The use of structured frameworks such as the Consolidated Framework for Implementation Research (CFIR) can help define complex implementation chal- lenges [5]. We deployed a comprehensive program to improve patient safety in Guatemala based on several components, including (1) tools to measure and foster a strong safety culture, (2) teaching principles of patient safety, (3) improving local governance, (4) enhanced safety event reporting, and (5) use of a team-based preoperative checklist [6–8]. The aim of the current study was to identify the barriers and facilitators for the implementation of this safety program in a perioperative unit in Guatemala.
Methods
Study Design and theoretical framework
We performed a qualitative implementation analysis of a patient safety program in the pediatric perioperative department at the Roosevelt Hospital in Guatemala. We collected staff views towards the implementation process using semi-structured interviews (SSIs) during the first phase of program implementation, and again through a focus group discussion (FGD) 1 year after program implementation. For SSIs as well as the FGD, we performed content analysis, and summarized outcomes using the Consolidated Framework for Implementation Research (CFIR) [5]. The CFIR is the most commonly used model to assess imple- mentation challenges within a global health context, and provides a model to understand the multi-level factors that impact health program implementation. This work was conducted in line with the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist (see Supplemental File 1) [9]. Note that this current report is not focused on clinical outcomes of the safety program as these data will not be available for several years, rather this report is focused on implemen- tation analysis during program deployment.
Interview tool
We created a 16-question interview tool using the CFIR Interview Guide (see Supplemental File 2) [5]. We prior- itized CFIR constructs based on our prior stakeholder analysis [7]. Questions are focused on implementation challenges for a perioperative safety program. The survey was translated into Spanish following the WHO Transla- tion guidelines [10]. Pretesting and cognitive interviews to ensure reliability were conducted with Guatemalan medical staff outside of the test units. The interview guide was
adapted for language clarity and cultural appropriateness [10].
Setting
This study was conducted in the pediatric perioperative unit of Roosevelt Hospital, a tertiary public hospital in Guatemala City. This unit has 61 staff members, with an average surgical volume of 25 cases per week. Attending physicians split their time between public and private practice, and are on-site primarily during morning hours.
Patient safety program
This safety program is composed of five mutually rein- forcing components: (1) tools to measure and foster a strong safety culture, (2) teaching principles of patient safety, (3) improving local governance, (4) safety event reporting, and (5) use of a team-based preoperative checklist (Fig. 1). Our current report focuses on implementation analysis of this program in the perioperative unit. Prior to this program, no comprehensive safety program had been used in this unit. Baseline practices included a paper checklist which was completed by anesthesiology staff during an operative procedure; no team-based checklist was used.
Interview data collection
For interviews, we used purposive sampling to identify 16 staff members within the perioperative unit, representing 25% of total staff. Interview participants were selected to
Fig. 1 Components of comprehensive perioperative patient safety program
leadership and staff throughout the implementation pro- cess, such that the program could be modified in a ‘‘real- time’’ iterative fashion during program implementation.
Results
We identified several areas impacting implementation of a perioperative safety program in Guatemala, representing challenges across CFIR domains, described as CFIR con- structs or subconstructs. Specifically, several constructs were facilitators to program implementation, including recognition of patient needs, compatibility with existing programs, and high staff motivation (Table 2). Major bar- riers included limited leadership engagement and organi- zational incentives, lack of knowledge, limited resources, and lack of formal implementation leaders (Table 2). Valence ratings summarized all CFIR constructs, demon- strating the direction and magnitude of all constructs (Table 3).
CFIR domain: outer setting
Implementation facilitator
Construct: patient needs Many respondents expressed positive views towards caring for patients, despite a high burden of clinical duties. Respondents noted strong feel- ings towards working with families and children, which serves to drive positive staff behaviors. Almost all staff reflected a strong personal commitment to the health needs of children.
‘‘I love my work. I love the patients; I owe it to patients … Im still excited and I continue to transmit to the young people, that we arent [perfect] but that
we are going to leave hope….’’ [Interview respondent 8]
CFIR domain: inner setting
Implementation barriers
Construct: readiness for implementation: leadership engagement Respondents considered the limited on-site attending physician presence in the unit as a barrier to program implementation. Both physician and nurse respondents noted that support of attending physicians was important to drive program adoption. Nurse respondents commented that the hierarchical leadership structure may impact readiness for implementation, and emphasized the importance of facilitating mid-level nursing and physician leadership.
‘‘What do I need? That our leaders meet with us, that we are part of their community. That we do not live in a separate world.’’ [Interview respondent 9]
Construct: Readiness for Implementation: Available Resources Many respondents discussed the difficulty of heavy workloads, limited manpower, and high patient volumes as challenges to implementation.
‘‘I think that we [physicians] have [limited] time to be organized in the hospital… I think the hard part is the [limited] time and the number of patients.’’ [Inter- view respondent 7]
Implementation facilitator
Construct: implementation climate: program compatibil- ity Most respondents believed that a patient safety pro- gram was compatible with department goals and workflow.
Table 2 Barriers and facilitators of patient safety program implementation within the consolidated framework for implementation research
CFIR domain Barriers Facilitators Program modifications
Outer setting Patient needs Adapt tools to best fit patients needs Inner setting Redlines for implementation: leadership engagement Redlines for implementation: available resources (i.e., time, staff)
Implementation climate compatibility
Equip mid-level and nursing leadership Align core safety program components with existing organizational work flow
Characteristics of individuals
Knowledge and beliefs about program Personal attributes Conduct educational workgroup and group training on PS tools Process Formally appointed internal implementation leaders
Designate physician and nurse champions
Consolidated framework for implementation research—CFIR; patient safety—PS. Dominant barriers and facilitators as reported by staff interviews as summarized by CFIR domains, with relevant construct or subconstruct (if available). Program modifications as reported by staff in initial staff interviews as well as through focus group discussion (FGD) 1-year post-implementation
Table 3 Valence ratings of consolidated framework for implementation research (CFIR) constructs
CFIR domain and constructs Definition Valence rating
I. Intervention characteristics domain Intervention source Perception of whether intervention development is external or internal? 1 Evidence strength and quality Perception of the quality and validity of the evidence supporting the use of patient safety program
? 1
Relative advantage Perception of the advantage of implementing a patient safety program versus an alternative or current practices
? 2
Adaptability The degree to which a patient safety program can be adapted to meet the needs of the unit? 1 Trialability The ability to test the intervention on a small scale, and to reverse course (undo implementation) if warranted
Missing
Complexity (reverse rated) Perceived complexity of the program as reflected by disruptiveness to existing workflows, intricacy, and number of implementation steps
Design quality and packaging Perceived quality of the patient safety program and how well these components are bundled and worked together
Missing
Cost Financial costs of implementing a safety program - 1 II. Outer setting domain Patient needs and resources The extent to which patients’ needs are known and prioritized (i.e., patient-centeredness)? 2 Cosmopolitanism Degree to which the unit is networked with external organizations? 1 Peer pressure Competitive pressure to implement an intervention because other organizations have implemented similar interventions
External policy and incentives Policies and incentives that support or hinder the implementation of patient safety programs - 2 III. Inner setting domain Structural characteristics The social architecture, maturity, and size of an organization - 1 Networks and communications Quality of formal and information communications within an organization - 1 Culture Norms and values of the department? 1 Implementation climate Tension for change The degree to which stakeholders perceive a need for change in the management of patients - 1 Compatibility The degree of fit between the patient safety program and the department’s values, norms, needs, and existing workflow
? 2
Relative priority Stakeholders’ perception of the importance of implementing the patient safety program? 1 Organizational incentives and rewards
Extrinsic incentives such as awards, performance reviews, promotions, and raises in salary, increased stature or respect
Goals and feedback The degree to which goals are communicated, acted upon, and fed back to staff and alignment of that feedback with goals
Learning climate The degree to which the unit has a climate that provides for reflective thinking and allows team members to try new methods
? 1
Readiness for implementation Leadership engagement Commitment, involvement, and accountability of perioperative local leadership - 2 Available resources The level of resources dedicated for the implementation and operations of the patient safety program
Access to knowledge and information
Ease of access to information and knowledge about patient safety program, process, and principles
IV. Characteristics of individuals domain Knowledge and beliefs about the intervention
Stakeholders’ knowledge and attitudes about the components and value of a comprehensive patient safety program
Self-efficacy Stakeholders’ belief in their own capabilities to execute their role in a patient safety program to achieve implementation goals
? 2
Individual stage of change The degree to which a stakeholder is progressing towards implementation and sustained use of a patient safety program
? 1
Individual identification with organization
The extent to which an individual perceives themselves and their responsibilities within the organization
? 1
CFIR domain: process
Implementation barrier
Construct: formally appointed internal implementation leaders Most participants suggested that the attending surgeon was the most appropriate person to lead a preop- erative timeout. However, many staff verbalized concerns that neither physicians nor other leaders are trained in patient safety. Staff also stated that as attending physicians are only present consistently during morning hours, it was unclear who would lead checklists during other times.
Program modifications
Participants in staff interviews as well as the FGD identi- fied modifications to enhance program implementation (Table 2). For example, to address the lack of knowledge of patient safety, local safety champions conducted educa- tional workshops on patient safety and surgical checklist utilization. Leveraging on high staff motivation, staff rolled out a revised timeout process to facilitate team engage- ment. Unit leadership designated nurse champions to lead timeouts, which facilitated checklist adherence during times when attending surgeons are not present.
Discussion
Implementation analysis is a key to ensure success of health interventions in LMICs, and can be particularly helpful in complex settings such as perioperative units [5, 11]. Our analysis demonstrated several lessons to improve implementation of a perioperative patient safety program in Guatemala, such as building on the strong desire of staff to learn about patient safety, leveraging staff interest in patient safety, and supporting nursing leadership of safety practices. Ensuring safe perioperative care around the world has focused on use of a preoperative checklist. The landmark study by Haynes et al. showed a reduction in perioperative morbidity after implementation of a surgical checklist in eight hospitals around the world [12]. However, several follow-up studies have showed conflicting impact of peri- operative checklists on clinical outcomes, poor quality of checklist process, as well as challenges to sustained use of a checklist [13]. Our data confirm several implementation challenges in our unit, and support engagement of all key stakeholders during the implementation process. Use of a structured implementation analysis framework, such as CFIR, allows for identification of the many inter- related factors which impact program implementation across each level of the organization [5]. By using a
structured approach for implementation analysis, we can define the major challenges to the implementation process, which can be particularly helpful in complex global health systems that face many internal and external stressors. For example, our analysis allowed us to organize the cultural and contextual factors which impact perioperative safety program implementation in Guatemala, such as the need for appointed local program leaders. Implementation analysis during deployment of a new health program allows for modification of the implemen- tation process itself to enhance program success. We learned during safety program implementation that staff wanted to learn about the role of safety culture. To address this need, we measured the safety culture early in the implementation process and identified areas that required attention, such as staff burnout, teamwork, and work–life balance [7]. As well, we confirmed the need to appoint unit nursing staff to lead timeout processes. There are several limitations to our analysis. First, this study was conducted at a single site, limiting the trans- ferability of findings. Second, our analysis did not include patients’ perspective on implementation challenges. Third, although it is important to measure the impact of a peri- operative safety program on clinical outcomes, this is beyond the capacity of this report. Our current analysis focused on the value of implementation analysis during program deployment, which allows for ‘‘real-time’’ pro- gram modification during the implementation process. In conclusion, we found several dominant themes which affect the implementation of a patient safety program in Guatemala. Facilitators to program implementation can be leveraged to enhance successful uptake of patient safety processes, such as building on strong staff enthusiasm, motivation for patient safety, and belief in the health needs of children. At the same time, attention to implementation barriers should be strategically addressed, such as the need for on-site leadership and staff education. Enhanced understanding of the challenges to implementation of patient safety programs has tremendous potential to improve perioperative safety in LMICs.
Acknowledgements The authors acknowledge Fernanda Navas, Marcos Lopez, Tomas Bolanos, Sofia Coti, Levin Yax, and Melany Puente for translation assistance. They also thank the Fundegua Foundation and the Universidad de San Carlos de Guatemala for their partnership
Funding Funding for this study was provided by the Duke Global Health Institute and by the Fogarty International Center, National Institutes of Health, USA (R03 TW010670, Rice PI).
Compliance with ethical standards
Conflict of interest Ms. Sico reported receiving grants from Duke University’s Duke Global Health Institute. Dr. Rice reported
receiving grants from National Institute of Health. No other disclo- sures were declared.
Ethics approval According to the policy activities that constitute research at Duke University, this work met criteria for operational improvement activities and was considered exempt from review by the Duke University Medical Center Institutional Review Board (Pro00076984).
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Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Isabelle P. Sico M.Sc. earned her Masters of Science in Glo- bal Health from the Duke Glo- bal Health Institute. Her research interests are at the intersection of clinical surgery, implementation science, and health services research both in the United States and in Low and Middle Income Countries. She has a passion for the deliv- ery and improvement of safe and high-quality healthcare and the successful implementation of innovative healthcare inter- ventions. Isabelle is honored to present her first publication in the World Journal of Surgery under the guidance and support of Dr. Henry E. Rice.
