Implementing Enhanced Recovery Pathways: A Qualitative Study of Factors That Distinguished Higher Performing Hospitals.

OBJECTIVE: The aim of this study was to explore barriers and facilitators to implementing enhanced recovery pathways, with a focus on identifying factors that distinguished hospitals achieving greater levels of implementation success. BACKGROUND: Despite the clinical effectiveness of enhanced recovery pathways, the implementation of these complex interventions varies widely. While there is a growing list of contextual factors that may affect implementation, little is known about which factors distinguish between higher and lower levels of implementation success. METHODS: We conducted in-depth interviews with 168 perioperative leaders, clinicians, and staff from 8 US hospitals participating in the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery. Guided by the Consolidated Framework for Implementation Research, we coded interview transcripts and conducted a thematic analysis of implementation barriers and facilitators. We also rated the perceived effect of factors on different levels of implementation success, as measured by hospitals' adherence with 9 process measures over time. RESULTS: Across all hospitals, factors with a consistently positive effect on implementation included information-sharing practices and the implementation processes of planning and engaging. Consistently negative factors included the complexity of the pathway itself, hospitals' infrastructure, and the implementation process of "executing" (particularly in altering electronic health record systems). Hospitals with the greatest improvement in process measure adherence were distinguished by clinicians' positive knowledge and beliefs about pathways and strong leadership support from both clinicians and executives. CONCLUSION: We draw upon diverse perspectives from across the perioperative continuum of care to qualitatively describe implementation factors most strongly associated with successful implementation of enhanced recovery pathways.

Critical Behaviors for Perioperative Improvement Teams.

Effectively leading perioperative safety and quality improvement requires a multidisciplinary team approach. However, leaders are often left without clear guidance on how to assemble and manage teams in these settings. We employ a Delphi process to prioritize specific behavioral strategies surgical safety and quality leaders can use to improve their chances of success implementing improvement efforts. We present the panel's consensus practical guidance on designing, managing, sustaining, training their teams as well as managing team boundaries and the organizational context.

Statewide Perinatal Quality Improvement, Teamwork, and Communication Activities in Oklahoma and Texas.

BACKGROUND AND OBJECTIVE: The purpose of this study was to describe statewide perinatal quality improvement (QI) activities, specifically implementation of Alliance for Innovation on Maternal Health (AIM) patient safety bundles and use of teamwork and communication tools in obstetric units in Oklahoma and Texas. METHODS: In January-February 2020, we conducted a survey of AIM-enrolled hospitals in Oklahoma (n = 35) and Texas (n = 120) to gather data on obstetric unit organization and QI processes. Data were linked to hospital characteristics information from the 2019 American Hospital Association survey and hospitals' maternity levels of care from state agencies. We generated descriptive statistics for each state and created an index to summarize adoption of QI processes. We fitted linear regression models to examine how this index varied by hospital characteristics and self-reported ratings for patient safety and AIM bundle implementation. RESULTS: Most obstetric units had standardized clinical processes for obstetric hemorrhage (94% Oklahoma; 97% Texas), massive transfusion (94% Oklahoma; 97% Texas), and severe hypertension in pregnancy (97% Oklahoma; 80% Texas); regularly conducted simulation drills for obstetric emergencies (89% Oklahoma; 92% Texas); had multidisciplinary QI committees (61% Oklahoma; 83% Texas); and conducted debriefs after major obstetric complications (45% Oklahoma; 86% Texas). Few obstetric units offered recent staff training on teamwork and communication to their staff (6% Oklahoma; 22% Texas); those who did were more likely to employ specific strategies to facilitate communication, escalate concerns, and manage staff conflicts. Overall, adoption of QI processes was significantly higher in hospitals in urban than rural areas, teaching than nonteaching, offering higher levels of maternity care, with more staff per shift, and greater delivery volume (all P < .05). The QI adoption index scores were strongly associated with respondents' ratings for patient safety and implementation of maternal safety bundles (both P < .001). CONCLUSIONS: Adoption of QI processes varies across obstetric units in Oklahoma and Texas, with implications for implementing future perinatal QI initiatives. Notably, findings highlight the need to reinforce support for rural obstetric units, which often face greater barriers to implementing patient safety and QI processes than urban units.

The Role of Oncology Nurses in Discussing Clinical Trials.

PURPOSE/OBJECTIVES: To describe oncology nurses' experiences discussing clinical trials with their patients, and to assess barriers to these discussions.
. RESEARCH APPROACH: A qualitative study designed to elicit narratives from oncology nurses. 
. SETTING: Community- and academic-based oncology clinics throughout the United States.
. PARTICIPANTS: 33 oncology nurses involved in direct patient care in community-based and large hospital-based settings. The sample was drawn from members of the Oncology Nursing Society. 
. METHODOLOGIC APPROACH: In-depth interviews were conducted and analyzed using a immersion/crystallization approach to identify themes and patterns. The analyses highlight specific issues, examples, and contexts that present challenges to clinical trial discussions with patients.
. FINDINGS: Oncology nurses view their roles as patient educators and advocates to be inclusive of discussion of clinical trials. Barriers to such discussions include lack of knowledge and strategies for addressing patients' common misconceptions and uncertainty about the timing of discussions.
. INTERPRETATION: These data indicate that enabling nurses to actively engage patients in discussions of clinical trials requires educational interventions to build self-efficacy and close knowledge gaps. 
. IMPLICATIONS FOR NURSING: Oncology nurses can play a critical role in advancing cancer care by supporting patients in decision making about clinical trial participation. This will require training and education to build their knowledge, reduce barriers, and increase their self-efficacy to fulfill this responsibility in various clinical settings.

Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.

PURPOSE: Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. PATIENTS AND METHODS: A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. RESULTS: Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. CONCLUSION: These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers.

Financial Concerns About Participation in Clinical Trials Among Patients With Cancer.

PURPOSE: The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. METHODS: We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): "How much of a burden on you is the cost of your medical care?," "I'm afraid that my health insurance won't pay for a clinical trial," and "I'm worried that I wouldn't be able to afford the costs of treatment on a clinical trial." Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. RESULTS: One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). CONCLUSION: Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients' financial needs and concerns may reduce distress and improve patient decision making.

Knowledge, attitudes, and self-efficacy as predictors of preparedness for oncology clinical trials: a mediational model.

OBJECTIVE: This study used the Ottawa Decision Support Framework to evaluate a model examining associations between clinical trial knowledge, attitudinal barriers to participating in clinical trials, clinical trial self-efficacy, and clinical trial preparedness among 1256 cancer patients seen for their first outpatient consultation at a cancer center. As an exploratory aim, moderator effects for gender, race/ethnicity, education, and metastatic status on associations in the model were evaluated. METHODS: . Patients completed measures of cancer clinical trial knowledge, attitudinal barriers, self-efficacy, and preparedness. Structural equation modeling (SEM) was conducted to evaluate whether self-efficacy mediated the association between knowledge and barriers with preparedness. RESULTS: . The SEM explained 26% of the variance in cancer clinical trial preparedness. Self-efficacy mediated the associations between attitudinal barriers and preparedness, but self-efficacy did not mediate the knowledge-preparedness relationship. CONCLUSIONS: . Findings partially support the Ottawa Decision Support Framework and suggest that assessing patients' level of self-efficacy may be just as important as evaluating their knowledge and attitudes about cancer clinical trials.

Application of best practice approaches for designing decision support tools: the preparatory education about clinical trials (PRE-ACT) study.

OBJECTIVE: This article describes the rigorous development process and initial feedback of the PRE-ACT (Preparatory Education About Clinical Trials) web-based- intervention designed to improve preparation for decision making in cancer clinical trials. METHODS: The multi-step process included stakeholder input, formative research, user testing and feedback. Diverse teams (researchers, advocates and developers) participated including content refinement, identification of actors, and development of video scripts. Patient feedback was provided in the final production period and through a vanguard group (N=100) from the randomized trial. RESULTS: Patients/advocates confirmed barriers to cancer clinical trial participation, including lack of awareness and knowledge, fear of side effects, logistical concerns, and mistrust. Patients indicated they liked the tool's user-friendly nature, the organized and comprehensive presentation of the subject matter, and the clarity of the videos. CONCLUSION: The development process serves as an example of operationalizing best practice approaches and highlights the value of a multi-disciplinary team to develop a theory-based, sophisticated tool that patients found useful in their decision making process. Practice implications Best practice approaches can be addressed and are important to ensure evidence-based tools that are of value to patients and supports the usefulness of a process map in the development of e-health tools.