A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

Background: Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers. Methods: Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms. Discussion: This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices. Trial registration: Clinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=

Does Screening for Pain Correspond to High Quality Care for Veterans?

Routine numeric screening for pain is widely recommended, but its association with overall quality of pain care is unclear. To assess adherence to measures of pain management quality and identify associated patient and provider factors. A cross-sectional visit-based study. One hundred and forty adult VA outpatient primary care clinic patients reporting a numeric rating scale (NRS) of moderate to severe pain (four or more on a zero to ten scale). Seventy-seven providers completed a baseline survey regarding general pain management attitudes and a post-visit survey regarding management of 112 participating patients. We used chart review to determine adherence to four validated process quality indicators (QIs) including noting pain presence, pain character, and pain control, and intensifying pharmacological intervention. The average NRS was 6.7. Seventy-three percent of charts noted the presence of pain, 13.9% the character, 23.6% the degree of control, and 15.3% increased pain medication prescription. Charts were more likely to include documentation of pain presence if providers agreed that “patients want me to ask about pain” and “pain can have negative consequences on patient’s functioning”. Charts were more likely to document character of pain if providers agreed that “patients are able to rate their pain”. Patients with musculoskeletal pain were less likely to have chart documentation of character of pain. Despite routine pain screening in VA, providers seldom documented elements considered important to evaluation and treatment of pain. Improving pain care may require attention to all aspects of pain management, not just screening

Tailoring an educational program on the AHRQ Patient Safety Indicators to meet stakeholder needs: lessons learned in the VA

Abstract Background Given that patient safety measures are increasingly used for public reporting and pay-for performance, it is important for stakeholders to understand how to use these measures for improvement. The Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators (PSIs) are one particularly visible set of measures that are now used primarily for public reporting and pay-for-performance among both private sector and Veterans Health Administration (VA) hospitals. This trend generates a strong need for stakeholders to understand how to interpret and use the PSIs for quality improvement (QI). The goal of this study was to develop an educational program and tailor it to stakeholders’ needs. In this paper, we share what we learned from this program development process. Methods Our study population included key VA stakeholders involved in reviewing performance reports and prioritizing and initiating quality/safety initiatives. A pre-program formative evaluation through telephone interviews and web-based surveys assessed stakeholders’ educational needs/interests. Findings from the formative evaluation led to development and implementation of a cyberseminar-based program, which we tailored to stakeholders’ needs/interests. A post-program survey evaluated program participants’ perceptions about the PSI educational program. Results Interview data confirmed that the concepts we had developed for the interviews could be used for the survey. Survey results informed us on what program delivery mode and content topics were of high interest. Six cyberseminars were developed—three of which focused on two content areas that were noted of greatest interest: learning how to use PSIs for monitoring trends and understanding how to interpret PSIs. We also used snapshots of VA PSI reports so that participants could directly apply learnings. Although initial interest in the program was high, actual attendance was low. However, post-program survey results indicated that perceptions about the program were positive. Conclusions Conducting a formative evaluation was a highly important process in program development. The useful information that we collected through the interviews and surveys allowed us to tailor the program to stakeholders’ needs and interests. Our experiences, particularly with the formative evaluation process, yielded valuable lessons that can guide others when developing and implementing similar educational programs

Translating electronic health record-based patient safety algorithms from research to clinical practice at multiple sites

Introduction Researchers are increasingly developing algorithms that impact patient care, but algorithms must also be implemented in practice to improve quality and safety.Objective We worked with clinical operations personnel at two US health systems to implement algorithms to proactively identify patients without timely follow-up of abnormal test results that warrant diagnostic evaluation for colorectal or lung cancer. We summarise the steps involved and lessons learned.Methods Twelve sites were involved across two health systems. Implementation involved extensive software documentation, frequent communication with sites and local validation of results. Additionally, we used automated edits of existing code to adapt it to sites’ local contexts.Results All sites successfully implemented the algorithms. Automated edits saved sites significant work in direct code modification. Documentation and communication of changes further aided sites in implementation.Conclusion Patient safety algorithms developed in research projects were implemented at multiple sites to monitor for missed diagnostic opportunities. Automated algorithm translation procedures can produce more consistent results across sites

“Clinical trials are space travel”: Factors of psychological response to recurrence among oncologists enrolling patients in treatment optimization trials

Abstract Background Cancer recurrence after treatment is a concern for patients and oncologists alike. The movement towards treatment optimization, with trials testing less than the current standard of care (SoC), complicates this experience. Our objective was to assess oncologists' psychological response to patient recurrence on optimization‐focused trials and identify factors that influence those experiences. Methods Clinical oncologists participated in a semi‐structured interview regarding patient enrollment in treatment optimization trials. We identified factors that influence the degree of psychological response that the oncologist may feel after patient recurrence. Residual agreement analysis was used to identify whether differences in reported psychological response was associated with alternative emphases on identified factors. Results Thirty‐six oncologists identified 20 factors spanning five major themes that affected their psychological response to patient recurrence. All oncologists expressed willingness to enroll patients in treatment optimization clinical trials; however, half indicated that they were more likely to experience a negative psychological response after a treatment optimization trial than after a traditional intensification trial, and a quarter reported that patient recurrence on an optimization trial would impact their recommendations for future trial enrollment. Oncologists who reported more negative psychological responses to patient recurrence after participation in an optimization trial were more likely to emphasize introspective factors, while those who reported no difference in response emphasized patient‐ and process‐focused factors. Conclusions Although most oncologists recognize the importance of treatment optimization trials, a significant proportion indicated a greater potential for psychological distress following patient recurrence in such trials and offered insight into how trial design and the process of patient enrollment can be improved to minimize those negative psychological responses

Additional file 5: of Tailoring an educational program on the AHRQ Patient Safety Indicators to meet stakeholder needs: lessons learned in the VA

PSI Educational Program Matrix. This file highlights information covered in each session of the PSI Educational Program and provides a list of materials referenced in each session. (PDF 213 kb

Additional file 1: of Tailoring an educational program on the AHRQ Patient Safety Indicators to meet stakeholder needs: lessons learned in the VA

Formative Evaluation: Interview Guide. This file provides the interview guide we used for the telephone interviews to obtain a general understanding of potential PSI educational needs and assess whether similar a priori concepts should inform the survey. (PDF 168 kb

Additional file 3: of Tailoring an educational program on the AHRQ Patient Safety Indicators to meet stakeholder needs: lessons learned in the VA

Post-program Evaluation Survey. This file provides the post-program survey that we administered to learn about stakeholders’ perceptions of the PSI Educational Program. (PDF 259 kb

Additional file 2: of Tailoring an educational program on the AHRQ Patient Safety Indicators to meet stakeholder needs: lessons learned in the VA

Formative Evaluation: Pre-program Survey. This file provides the survey that we administered to obtain stakeholders’ input on their educational needs related to the PSIs. (PDF 169 kb