Patient-Centered Outcomes Research Research Articles

Abstract PO4-13-04: Added Value from Patient Advocates in a Translational Working Group: the COMET Study

Abstract Introduction: A phase III multicenter prospective randomized clinical trial called “Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET)” (NCT02926911) assesses the risks/benefits of active monitoring (AM) versus surgery for women with low-risk ductal carcinoma in situ (DCIS). It is funded by the Patient-Centered Outcomes Research Institute and enrolled 997 women between 06/30/17 and 01/13/23. Research Patient Advocates (PAs) have been embedded from the study design stage and continue to provide guidance as part of the COMET leadership team. The COMET biobank is funded by independent foundations and is managed through monthly Translational Working Group (TWG) meetings. The TWG includes PAs, clinicians, pathologists, radiologists, and researchers from multiple institutions who discuss topics like categorization of biospecimens into discovery/validation sets; development of a pathology workflow/sample tracking process; use of small samples; and potential areas of future research/technologies that may improve DCIS diagnostics, prognostics, and care management. Methods: The TWG leveraged the existing Alliance Foundation Trials, LLC biobank infrastructure and facilitates the collection, submission, storage and analysis/use of blood, tissue, and breast images collected at specified timepoints and stored in central tissue/image repositories. PAs are active and integral in the TWG, assisting with logistical issues (contracts, transfer agreements, resource requests); communicating with sites; identifying study topics and biomarkers relevant to diverse patients; providing guidance on commercial predictive/prognostic tests; promoting effective stewardship of samples; ensuring overall focus remains on advancing clinical utility; and reporting translational study results to trial participants who agreed to donate samples/images. Results: Over 90% of requested samples/images have been submitted by ˃85 sites. Each patient’s biospecimens and pathology images are linked and de-identified for research. Use of artificial intelligence (AI) is being considered to assist in sample review. TWG members have complementary areas of expertise/experience and promote active stewardship for effective management of these scarce resources. PAs have played key roles concerning equitable data-sharing and acceleration of data and material transfer agreements. They have also been active in development of standards for discovery/training sets, validation test sets; communication procedures for patient cases that progress to future breast events; ways to catalog technologies (e.g., multi-omics, AI); and in research proposal review. Consensus has been achieved regarding major issues such as authorship, biospecimen custodianship, intellectual property, and criteria relevant to patient needs. Logistical barriers, including data sharing and technicalities of biospecimen release, have been resolved. The TWG also played an integral role in resolving recruitment challenges to COMET by creating standard pathology eligibility criteria, resulting in evidence-based protocol amendments that increased accrual. A retrospective review of biospecimens has been performed to determine adequacy for ensuing correlative molecular and spatial profiling studies. Conclusion: PAs help the COMET TWG set policy, and oversee biospecimen/image collection, and biobank use and sharing. PA input also facilitates equitable, transparent research studies and technology development that can improve personalized decisions for surgery versus AM in women with low-risk DCIS. PAs in the TWG aim to integrate the diagnostic and prognostic tools developed as part of the COMET study into future patient care. Citation Format: Deborah Collyar, Desiree Basila, Thomas Lynch, Stuart Schnitt, Jeffrey Marks, Siri Strand, Terry Hyslop, Sunil Badve, Mark Watson, H. T. Carisa Le-Petross, Lars Grimm, Robert West, Anna Weiss, Anna Rapperport, Lorraine King, Rachel Factor, Marc Ryser, Ann Partridge, E Shelley Hwang, Alastair Thompson. Added Value from Patient Advocates in a Translational Working Group: the COMET Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-13-04.

Improving Data Infrastructure for Person-Centered Outcomes Research on Intellectual and Developmental Disabilities.

Individuals with intellectual and developmental disabilities (IDD) continue to experience disparities in health and well-being despite improved provisions of person-centered care. Patient-centered outcomes research (PCOR) translates evidence into practice for meaningful outcomes. This piece describes findings from an environmental scan and stakeholder outreach to identify and prioritize opportunities to enhance IDD PCOR data infrastructure. These opportunities include developing a standardized research definition; advancing data standards for service systems; improving capture of IDD at point of care; developing standardized outcome measures; and encouraging Medicaid data use for IDD research. Within this piece, we discuss the implications of addressing data gaps for enhanced research. While the identified activities provide a path towards advancing IDD PCOR data infrastructure, collaborative efforts between government, researchers, and others are paramount.

Abstract 1302: Development and implementation of a systematic approach to measure patient-reported outcomes in early-phase cancer trials

Abstract Background: There has been a shift in the clinical trial landscape toward early-phase studies where data from well-designed and pivotal phase I/II trials is leading to accelerated drug approval. Our goal was to develop a standardized approach to the measurement and reporting of patient-reported outcomes (PROs) in early-phase trials to improve assessment of tolerability, address noted barriers to inclusion, and enhance patient-provider communication to inform treatment decisions and ultimately improve outcomes. Methods: The Office of Patient Centered Outcomes Research (OPCORe) was established in 2022 within the Center for Cancer Research at the National Cancer Institute (NCI) with the mission to advance understanding of the clinical benefit and tolerability of cancer therapies by integrating patient-centered approaches into CCR clinical trials by fostering education and collaboration with stakeholders. Implementation of regulatory/consortia guidelines related to use of core constructs, assessment frequency, and hypothesis-driven objectives and analysis plans through protocol template, development of data capture, email-based alerts and data visualization for clinical providers was developed and standardized templates for protocol language, research staff education, tools for workflow, and tracking implemented. Results: The OPCORe protocol template includes measurement of 3 constructs, including tolerability, clinical benefit and disease-specific impact, as well as anchors of meaningful change. Core symptomatic toxicities are measured to inform understanding across trials with agent/class-specific symptomatic toxicities added to assure relevance. Baseline and standardized weekly electronic capture of tolerability during early cycles with alerts to clinical research staff if moderate-severe toxicities reported helps facilitate patient check-ins. Repeat PROs assessments in later cycles are expanded to include disease-specific assessments and align with disease evaluation to further inform clinical impact. To date, we have collaborated with 7 research groups and developed approaches for first-in-human, phase I, and phase II studies with trial start-up and data collection in process. Conclusion: The value of including PROs in cancer trials is increasingly recognized by regulators, clinicians, patients, and advocates to advance understanding of the clinical benefit & tolerability of emerging therapies. Standardization and incorporation of PROs in earlier phase trials may enable PROs to be optimized, improve later phase trial design, and help inform health policy, support drug approval, and promote shared decision making between providers and patients to inform treatment decisions. Citation Format: Amanda L. King, Jason E. Levine, Elizabeth Vera, Yuti Gandhi, Elaine Novakovich, Theresa Yu, Sefanit Berhanu, Ciara Locke, Kaelyn Julmeus, Tito Mendoza, Terri S. Armstrong. Development and implementation of a systematic approach to measure patient-reported outcomes in early-phase cancer trials [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1302.

An Overview of the Methodology Used to Develop Clinical Practice Guidelines for the Management of Acute and Intraoperative Spinal Cord Injury.

An overview of the methods used to develop clinical practice guidelines (CPGs). Acute spinal cord injury (SCI) and intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. To date, there are several studies that have discussed the diagnostic and management strategies for both SCI and ISCI. CPGs in SCI help to distill and translate the current evidence into actionable recommendations, standardize care across centers, optimize patient outcomes, and reduce costs and unnecessary interventions. Furthermore, they can be used by patients to assist in making decisions about certain treatments and by policy makers to inform allocation of resources. The objective of this article is to summarize the methods used to develop CPGs for the timing of surgery and hemodynamic management of acute SCI, as well as the identification and treatment of ISCI. The CPGs were developed using standards established by the Institute of Medicine (now the National Academy of Medicine), the Guideline International Network and several other organizations. Systematic reviews were conducted according to accepted methodological standards (eg, Institute of Medicine, Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute) in order to summarize the current body of evidence and inform the guideline development process. Protocols for each guideline were created. A multidisciplinary guideline development group (GDG) was formed that included individuals living with SCI as well as clinicians from the broad range of specialties that encounter patients with SCI: spine or trauma surgeons, critical care physicians, rehabilitation specialists, neurologists, anesthesiologists and other healthcare professionals. Individuals living with SCI were also included in the GDG. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to rate the certainty of the evidence for each critical outcome. The "evidence to recommendation" framework was then used to translate the evidence obtained from the systematic review to an actionable recommendation. This framework provides structure when assessing the body of evidence and considers several additional factors when rating the strength of the recommendation, including the magnitude of benefits and harms, patient preferences, resource use, health equities, acceptability and feasibility. Finally, the CPGs were appraised both internally and externally. The results of the CPGs for SCI are provided in separate articles in this focus issue. Development of these CPGs for SCI followed the methodology proposed by the Institute of Medicine the Guideline International Network and the GRADE Working Group. It is anticipated that these CPGs will assist clinicians implement the best evidence into practice and facilitate shared-decision making with patients.

Raising the Bar for Real-World Data in Oncology: Approaches to Quality Across Multiple Dimensions.

Electronic health record (EHR)-based real-world data (RWD) are integral to oncology research, and understanding fitness for use is critical for data users. Complexity of data sources and curation methods necessitate transparency into how quality is approached. We describe the application of data quality dimensions in curating EHR-derived oncology RWD. A targeted review was conducted to summarize data quality dimensions in frameworks published by the European Medicines Agency, The National Institute for Healthcare and Excellence, US Food and Drug Administration, Duke-Margolis Center for Health Policy, and Patient-Centered Outcomes Research Institute. We then characterized quality processes applied to curation of Flatiron Health RWD, which originate from EHRs of a nationwide network of academic and community cancer clinics, across the summarized quality dimensions. The primary quality dimensions across frameworks were relevance (including subdimensions of availability, sufficiency, and representativeness) and reliability (including subdimensions of accuracy, completeness, provenance, and timeliness). Flatiron Health RWD quality processes were aligned to each dimension. Relevancy to broad or specific use cases is optimized through data set size and variable breadth and depth. Accuracy is addressed using validation approaches, such as comparison with external or internal reference standards or indirect benchmarking, and verification checks for conformance, consistency, and plausibility, selected on the basis of feasibility and criticality of the variable to the intended use case. Completeness is assessed against expected source documentation; provenance by recording data transformation, management procedures, and auditable metadata; and timeliness by setting refresh frequency to minimize data lags. Development of high-quality, scaled, EHR-based RWD requires integration of systematic processes across the data lifecycle. Approaches to quality are optimized through knowledge of data sources, curation processes, and use case needs. By addressing quality dimensions from published frameworks, Flatiron Health RWD enable transparency in determining fitness for real-world evidence generation.

Comparative effectiveness of azathioprine and mycophenolate mofetil for myasthenia gravis (PROMISE-MG): a prospective cohort study

Myasthenia gravis is an autoimmune disorder of the neuromuscular junction. Treatment typically includes symptomatic oral cholinesterase inhibitors, immunosuppression, and immunomodulation. In addition to corticosteroids, azathioprine and mycophenolate mofetil are the most frequently used immunosuppressants in North America. We aimed to evaluate the comparative effectiveness of these two drugs, and to assess the effect of the dose and duration of treatment. We did a prospective cohort study at 19 academic centres in Canada and the USA. We included patients (aged ≥18 years) with autoimmune myasthenia gravis, who were never treated with immunosuppressants. Treating clinicians determined the choice of medication, dose, follow-up intervals, and drug monitoring. Outcome measures and adverse events were recorded at each visit. We assessed two co-primary outcomes. The first was the patient-reported Myasthenia Gravis-Quality of Life 15-revised (MGQOL-15r) score, measured as the mean change from treatment initiation to the follow-up visit with the lowest score. A clinically meaningful reduction (CMR) in MGQOL-15r was defined as a 5-point decrease. The second was a composite clinical outcome of disease improvement (Myasthenia Gravis Foundation of America Post-Intervention Status Minimal Manifestations or better) and low adverse event burden (defined as grade ≤1 Common Terminology Criteria for Adverse Events). We also compared these outcomes in patients receiving an adequate dose and duration of azathioprine (≥2 mg/kg per day for at least 12 months) or mycophenolate mofetil (≥2 g per day for at least 8 months) and a lower dose or shorter duration of these agents. We used propensity score weighting with generalised linear regression models. This study is registered with ClinicalTrials.gov (NCT03490539). Between May 1, 2018, and Aug 31, 2020, 167 patients were enrolled; 85 did not receive azathioprine or mycophenolate mofetil and were excluded. Four were excluded from outcome analyses because they had scores of 0 on an outcome measure at treatment initiation. Of the 78 patients included in analyses, 47 received mycophenolate mofetil (median follow-up 25 months [IQR 13·5-31·5]) and 31 received azathioprine (median follow-up 20 months [IQR 13-30]). The mean change in MG-QOL15r was -10·4 (95% CI -18·9 to -1·3) with mycophenolate mofetil and -6·8 (-17·2 to 3·6) with azathioprine (mean difference -3·3, 95% CI -7·7 to 1·2; p=0·15). 38 (81%) of 47 patients receiving mycophenolate mofetil and 18 (57%) of 31 receiving azathioprine had a CMR in MG-QOL15r (risk difference 24·0%; 95% CI -0·2 to 48·0; p=0·052). The clinical composite outcome was achieved in 22 (47·7%) of 47 patients who received mycophenolate mofetil and nine (28·1%) of 31 who received azathioprine (risk difference 19·6%, 95% CI -4·9 to 44·2; p=0·12). Descriptive analysis did not find a difference in the proportion of patients reaching a CMR in MG-QOL15r between the adequate dose and duration group and the lower dose or shorter duration group. Adverse events occurred in 11 (32%) of 34 patients who received azathioprine and nine (19%) of 48 who received mycophenolate mofetil. The most frequent adverse events were hepatotoxicity with azathioprine (five [15%] of 34) and gastrointestinal disturbances (seven [15%] of 48) with mycophenolate mofetil. There were no study-related deaths. More than half of patients treated with azathioprine and mycophenolate mofetil felt their quality of life improved; no difference in clinical outcomes was noted between the two drugs. Adverse events associated with azathioprine were potentially more serious than those with mycophenolate mofetil, although mycophenolate mofetil is teratogenic. Lower than recommended doses of azathioprine might be effective, with reduced dose-dependent adverse events. More comparative effectiveness studies are required to inform treatment choices in myasthenia gravis. Patient-Centered Outcomes Research Institute, Myasthenia Gravis Foundation of America.

Navigating the path of progress: The OMERACT 2023 emerging leaders program

ObjectivesThe Outcome Measures in Rheumatology Clinical Trials (OMERACT) Emerging Leaders Program (ELP) aims to cultivate a cohort of skilled leaders within the OMERACT community empowering them with expertise and knowledge to help shape and steer the organization into the future. This publication highlights the significance of the ELP in driving leadership excellence, its impact on OMERACT's evolution, and the outcomes and learnings from the OMERACT 2023 ELP. MethodsInsights from the 2018 ELP report informed 2023 program improvements. Engagement was measured by attendance and WhatsApp interactions. Positive program aspects, areas for improvement and ideas for enhancing future ELPs were captured via anonymous survey and participant focus groups. ResultsEngagement with the ELP was high with 9 participants, 96 % attendance at all workshops, 154 WhatsApp interactions. All program components were highly rated, with the highest being the ‘Psychological Safety’ and ‘Methodology/Process/Politics’ workshops. Future enhancements included creating further networking, connection and support activities, practical leadership and methodological skill development opportunities, and a new stream focussing on organisational advancement. ConclusionsThe 2023 OMERACT ELP was well received and successfully addressed areas previously identified as requiring improvement. New educational enhancements were valued, and the importance of fostering psychological safety at all levels was highlighted. The ELP fortifies OMERACT by nurturing a diverse array of skilled leaders who embody OMERACTs core values. Continuing to refine and evolve the ELP over time will help OMERACT sustain its global influence in patient-centered outcome research.

Patient-centered research in pediatric transplant: Engaging families and recipients

Pediatric liver transplant (LT) recipients navigate a lifelong journey that includes constant monitoring and challenges. Research priorities and questions in LT have traditionally been provider-driven. This project was a novel partnership between a learning health system dedicated to pediatric LT (Starzl Network for Excellence in Pediatric Transplantation) and a parent-led advocacy group (Transplant Families) that aimed to prepare families and providers for collaborative patient-centered outcomes research (PCOR). We developed 5 virtual modules to (1) teach participants about PCOR, and (2) elicit ideas for PCOR priorities and processes in pediatric LT. Parents and providers participated via self-guided online modules or focus groups. Participants included 240 patient partners and 133 pediatric LT providers from 16 centers over 2 years. We held 20 focus groups, including 5 to amplify underrepresented voices: young adults, Spanish speakers, and African Americans. Feedback was summarized to create a PCOR Roadmap, a guide for future PCOR in the Starzl Network, which was disseminated back to participants online and via webinars. Feedback from a diverse group of stakeholders allowed us to develop PCOR priorities and processes for the pediatric LT community. Our engagement strategies could be adapted by other transplant communities to facilitate patient and provider research partnerships.

Advanced and alternative research methods for the acute care surgeon scientist

Clinical research has evolved significantly over the last few decades to include many advanced and alternative study designs to answer unique questions. Recognizing a potential knowledge gap, the AAST Associate...

Building Statewide Quality Improvement Capacity to Improve Cardiovascular Care and Health Equity: Lessons from the Tennessee Heart Health Network

Many states with high rates of cardiovascular disease (CVD) lack statewide quality improvement (QI) infrastructure (for example, resources, leadership, community) to address relevant health needs of the population. Academic health centers are well positioned to play a central role in addressing this deficiency. This article describes early experience and lessons learned in building statewide QI infrastructure through the Tennessee Heart Health Network (Network). A statewide, multistakeholder network composed of primary care practices (PCPs), health systems, health plans, QI organizations, patients, and academic institutions was led by the University of Tennessee Health Science Center (UTHSC), an academic health center, to improve cardiovascular health by supporting dissemination and implementation of patient-centered outcomes research (PCOR) evidence-based interventions in primary care. PCPs were required to select and implement at least one of three interventions (health coaching, tailored health-related text messaging, and pharmacist-physician collaboration). Thirty statewide organizational partners joined the Network in year one, including 18 health systems representing 77 PCPs (30.0% of 257 potentially eligible PCPs identified) with approximately 300,000 patients. The organizational partners share EHRs for the ongoing tracking and reporting of key health metrics, including hypertension control and delivery of tobacco cessation counseling. Of the 77 PCPs, 62 continue participation after year two (80.5% retention). Main barriers to participation and reasons for discontinuing participation included reluctance to share data and changes in leadership at the health system level. These 62 PCPs selected the following interventions to implement: health coaching (41.9%), tailored health-related text messages (48.4%), and pharmacist-physician collaboration (40.3%). Academic health centers have broad reach and high acceptability by diverse stakeholders. Tennessee's experience illustrates how academic health centers can serve as platforms for building a statewide infrastructure for disseminating, implementing, and sustaining QI interventions at the practice level. Assessment of Network impact is ongoing.

Skin Antisepsis before Surgical Fixation of Extremity Fractures

BackgroundStudies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).MethodsIn a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.ResultsA total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.ConclusionsAmong patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)

Making progress against rare cancers: A case study on neuroendocrine tumors.

In April 2023, the National Cancer Institute offered a roadmap for cancer research to achieve Cancer Moonshot goals. To reach these goals requires making progress for all cancers, not just those that are most common. Achieving progress against rare cancers, as well as common cancers, requires involvement of large clinical research networks. In 2020, the Patient-Centered Outcomes Research Institute (PCORI) launched an initiative on Conducting Rare Disease Research using PCORnet, the National Patient-Centered Clinical Research Network. The purpose of this commentary is to introduce the broader community of cancer researchers to the PCORnet NET-PRO study (comparing the effects of different treatment approaches for neuroendocrine tumors on patient-reported outcomes) thereby demonstrating how researchers can use the PCORnet infrastructure to conduct large-scale patient-centered studies of rare cancers.

How Do Consumers Interact with Digital Expert Advice? Experimental Evidence from Health Insurance

Consumers increasingly use digital advice when making purchasing decisions. How do such tools change consumer behavior and what types of consumers are likely to use them? We examine these questions with a randomized controlled trial of digital expert advice in the context of prescription drug insurance. The intervention we study was effective at changing consumer choices. We propose that, conceptually, expert advice can affect consumer choices through two distinct channels: by updating consumer beliefs about product features (learning) and by influencing how much consumers value product features (interpretation). Using our trial data to estimate a model of consumer demand, we find that both channels are quantitatively important. Digital expert advice tools not only provide consumers with information, but also alter how consumers value product features. For example, consumers are willing to pay 14% less for a plan with the most popular brand and 37% less for an extra star rating when they incorporate digital expert advice on plan choice relative to only having information about product features. Further, we document substantial selection into the use of digital advice on two margins. Consumers who are inherently less active shoppers and those who we predict would have responded to advice more were less likely to demand it. Our results raise concerns regarding the ability of digital advice to alter consumer preferences as well as the distributional implications of greater access to digital expert advice. This paper was accepted by Stefan Scholtes, healthcare management. Funding: This work was supported by the National Institute on Aging [Grant K01AG059843] and the Patient-Centered Outcomes Research Institute [Grant CDR-1306-03598]. The project also received financial support from Stanford Innovation Funds. Supplemental Material: The online appendix and data files are available at https://doi.org/10.1287/mnsc.2020.02453 .

Engaging patients and stakeholders to identify a research agenda to support social determinants of health (SDOH) screening and intervention initiatives in community pharmacy

Community pharmacists can play a vital role in supporting the nation’s effort to address patients’ social needs at a scalable, system-wide level. However, evidence is scarce related to the acceptability, and effectiveness of existing programs that administer social determinants of health (SDOH) screening and referral interventions. The Pharmacy Quality Alliance and National Patient Advocate Foundation convened a multistakeholder panel consisting of patient and pharmacy stakeholders in 2022 to develop a patient-centered outcomes research (PCOR) agenda for community pharmacies. Guided by the Patient-Centered Outcomes Research Institute’s Engagement Rubric, the series of three workshops sought to amplify the patient voice throughout the process. Identified priorities include research to support the development of infrastructure required to incorporate SDOH screening and intervention programs into existing workflows; defining the feasibility of screening and interventions in the community pharmacy setting; and understanding patient perception and preferences on communication strategies, educational outreach efforts, and appropriate handling of sensitive information related to social needs. Pharmacy stakeholders emphasized the importance of generating evidence to demonstrate the effectiveness of programs to support the development of reimbursement strategies aimed at the long-term sustainability of effective programs. Developing patient and community collaborations and integrating efforts with other healthcare professionals is going to be vital to minimize care fragmentation and maximize the healthcare system’s overall ability to address patients’ social needs. Future research efforts should examine the impact of multisectoral collaboration to address patients’ social needs, patient experience with the interventions, and the effectiveness of the interventions themselves.

BUILDING BRIDGES AND CATALYZING RESEARCH FOR EVIDENCE-BASED INFECTION CONTROL: PROJECT ECHO FOR NURSING HOMES

Abstract Nursing homes were ill-equipped for the pandemic; though facilities are required to have infection control staff, only 3% have taken a basic infection control course. Significant research has focused on infection control in the acute care setting; however, little is known about the implementation of infection control practices in long-term care communities. In this symposium, we will describe findings from the Project ECHO for Nursing Homes- a national, Patient-Centered Outcomes Research Institute (PCORI) funded study. First, Dr. Kraschnewski will present over all study findings from the stratified, cluster randomized controlled trial of 136 nursing homes that participated in up to 33 weeks of best-practice training to improve COVID-19 infection control practices. Next, Dr. Calo will present on implementation outcomes at 6-months including readiness for change and the implementation climate in the NH. Next, Ms. Heilbrunn will discuss the impacts of implementing evidence-based infection control practices through COVID-19 on NH residents’ well-being. Finally, Dr. Behrens will describe NH leadership perspectives (n=14) on preparing and maintaining care quality during times of diminishing resources. Data presented in this symposium can guide NHs in strategies to implement evidence-based infection control in their homes and informs researchers who are looking to implement similar implementation studies in the NH setting.

Mission Alliance Community Engagement Project: Exploring the Impact of COVID-19 on Social Isolation, Loneliness, Mental Health and Wellbeing in Veterans

During the Coronavirus disease pandemic, many U.S. veterans with posttraumatic stress disorder (PTSD) experienced increased symptomology and worsened mental health and well-being due in part to social isolation and loneliness. The Mission Alliance project explored these ramifications and prioritized critical issues expressed by U.S. veterans and stakeholders (N = 182) during virtual regional meetings (N = 32). Field notes created specifically for this project were recorded and thematically analyzed. Emerging themes included: (1) social isolation: missed opportunities, collapsed social circles, work-life balance, fostering relationships, and evolving health care delivery; (2) loneliness: deteriorated mental health, suffered with PTSD together but alone, looked out for each other, ambivalence toward technology, and strained and broken systems; (3) mental health: sense of chaos, increased demand and decreased access, aggravation, implementation of tools, innovative solutions, fear and loss, and availability of resources; (4) wellbeing: sense of purpose, holistic perspective on well-being, recognition of balance, persisting stigma, redefined pressures, freedom to direct treatment, and reconnection and disconnection. A PTSD-related patient centered outcomes research (PCOR)/comparative effectiveness research (CER) agenda was developed from these themes. Establishment of a veteran and stakeholder network is suggested to support, facilitate, and promote the PTSD-related PCOR/CER agenda. Furthermore, enhancement of opportunities for veterans with PTSD and stakeholders to partner in PCOR/CER is required to develop and conduct projects that lead to PTSD-related comprehensive care of veterans affected by traumatic events with the potential to translate findings to other populations.

Hearing the Older Adults and Caregivers Voice in Medication Optimization Initiatives

AbstractBackgroundEngaging older adults, caregivers and family is necessary to produce relevant and meaningful evidence. Patient‐centered‐outcomes research (PCOR) engages these individuals as research partners. For instance, the process of shared decision‐making about deprescribing (reducing or stopping potentially inappropriate medications) between people living with dementia and their carers (consumers), and clinicians, is complex.MethodVarious tactics were employed by the Elder Care Medicine Network (ECMN) and stakeholder steering groups from USA and Australia. These initiatives describes efforts to increase capacity of local communities – older adults, their caregivers, healthcare providers and researchers – to participate in medication related PCOR as well as the development of a tool (PRIME) to help with deprescribing medications for individuals with dementia.ResultThere are over 120 active participants in the ECMN. After they shared their PCOR training needs, trainings were held as Discussion sessions where Council members and network participants shared their medication experiences and talked about participating on a PCOR research team. Network participants also identified what they felt were meaningful research questions on medication‐related PCOR (video). Additionally the PRIME tool was developed via an iterative process utilizing one‐to‐one semi‐structured interviews and a focus group session with 39 participants (people living with dementia, carers, and clinicians) to determine the usability and comprehensibility of the PRIME tool. Iterative changes were made to improve the content and layout of the tool.ConclusionThese two initiatives illustrate the importance of co‐design and incorporating the older adults and caregivers voice in medication optimization efforts in individuals with dementia.

PCR163 Modification of the Social Ecological Model to Distinguish the Terms “HRQoL” and “QoL” in Patient-Centered Outcomes Research

PCR163 Modification of the Social Ecological Model to Distinguish the Terms “HRQoL” and “QoL” in Patient-Centered Outcomes Research

Key Principles Underlying a Research-Practice Alignment in a Federally Qualified Health Center

Context Minoritized populations such as racial and ethnic minorities and individuals of less privileged socioeconomic status experience a disproportionate burden of poor hypertension (HTN) control in the United States. Multilevel systems interventions have been shown to improve patient-level outcomes in minoritized populations; however, there remains a large translational gap in implementing these approaches into federally qualified health centers (FQHC), which serve those at highest risk of HTN-related morbidity and mortality. The paucity of purposeful collaborations between academic researchers and practice staff throughout the research process remains a significant roadblock to the timely translation of evidence to practice. Design This commentary describes the key principles and best practices that underlie the development and sustainment of an equitable research-practice alignment, which is supporting the implementation of multilevel systems intervention for improved HTN care in a large FQHC in Brooklyn, New York. The key principles, which are derived from the central tenants of relationship development and maintenance in community-engaged participatory research, patient-centered outcomes research, and organizational alignment theory include (1) cocreation of a shared mental model, (2) bridging multilevel communication, (3) ensuring mutual accountability, and (4) creating a culture of continuous improvement. Conclusions Together, the principles guide how the research and practice teams work together to achieve a shared goal of improving the health and well-being of minoritized patients through the provision of high quality, community-oriented HTN care. Best practices to sustain our alignment require an ongoing and deliberate investment in honest and transparent communication by all members.

Pragmatic design and inclusion of patient-partner representatives improves participant experience in clinical research.

Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.