The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization.
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ABSTRACT:
SUBMITTER: Huang DT
PROVIDER: S-EPMC8144687 | biostudies-literature | 2021 May
REPOSITORIES: biostudies-literature
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The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization.
Huang David T DT McCreary Erin K EK Bariola J Ryan JR Wadas Richard J RJ Kip Kevin E KE Marroquin Oscar C OC Koscumb Stephen S Collins Kevin K Shovel Judith A JA Schmidhofer Mark M Wisniewski Mary Kay MK Sullivan Colleen C Yealy Donald M DM Axe Meredith M Nace David A DA Haidar Ghady G Khadem Tina T Linstrum Kelsey K Snyder Graham M GM Seymour Christopher W CW Montgomery Stephanie K SK McVerry Bryan J BJ Berry Lindsay L Berry Scott S Meyers Russell R Weissman Alexandra A Peck-Palmer Octavia M OM Wells Alan A Bart Robert R Albin Debbie L DL Minnier Tami T Angus Derek C DC
Trials 20210525 1
<h4>Objectives</h4>The primary objective is to evaluate the comparative effectiveness of COVID-19 specific monoclonal antibodies (mABs) with US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), alongside UPMC Health System efforts to increase patient access to these mABs.<h4>Trial design</h4>Open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization PARTICIPANTS: We will evaluate patients who meet the eligibility criteria stipulated b ...[more]
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Project description:BackgroundPragmatic trials, because they study widely used treatments in settings of routine practice, require intensive participation from clinicians who determine whether patients can be enrolled. Clinicians are often conflicted between their therapeutic obligation to patients and their willingness to enroll them in trials in which treatments are randomly determined and thus potentially suboptimal. Refusal to enroll eligible patients can hinder trial completion and damage generalizability. In order to help evaluate and mitigate clinician refusal, this qualitative study examined how clinicians reason about whether to randomize eligible patients.MethodsWe performed interviews with 29 anesthesiologists who participated in REGAIN, a multicenter pragmatic randomized trial comparing spinal and general anesthesia in hip fracture. Interviews included a chart-stimulated section in which physicians described their reasoning pertaining to specific eligible patients as well as a general semi-structured section about their views on clinical research. Guided by a constructivist grounded theory approach, we analyzed data via coding, synthesized thematic patterns using focused coding, and developed an explanation using abduction.ResultsAnesthesiologists perceived their main clinical function as preventing peri- and intraoperative complications. In some cases, they used prototype-based reasoning to determine whether patients with contraindications should be randomized; in others, they used probabilistic reasoning. These modes of reasoning involved different types of uncertainty. In contrast, anesthesiologists expressed confidence about anesthetic options when they accepted patients for randomization. Anesthesiologists saw themselves as having a fiduciary responsibility to patients and thus did not hesitate to communicate their inclinations, even when this complicated trial recruitment. Nevertheless, they voiced strong support for clinical research, stating that their involvement was mainly hindered by production pressure and workflow disruptions.ConclusionsOur findings suggest that prominent ways of assessing clinician decisions about trial randomization are based on questionable assumptions about clinical reasoning. Close examination of routine clinical practice, attuned to the features of clinical reasoning we reveal here, will help both in evaluating clinicians' enrollment determinations in specific trials and in anticipating and responding to them.Trial registrationRegional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN).Clinicaltrialsgov NCT02507505. Prospectively registered on July 24, 2015.
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Project description:BackgroundOver the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and implementation studies have natural areas of overlap, particularly relating to the goal of using clinical trial data to leverage health care system policy changes. Few investigations have addressed pragmatic and implementation science randomized trial methods development while also considering policy impact.MethodsThe investigation used the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) and PRECIS-2-Provider Strategies (PRECIS-2-PS) tools to evaluate the design of two multisite randomized clinical trials that targeted patient-level effectiveness outcomes, provider-level practice changes and health care system policy. Seven raters received PRECIS-2 training and applied the tools in the coding of the two trials. Descriptive statistics were produced for both trials, and PRECIS-2 wheel diagrams were constructed. Interrater agreement was assessed with the Intraclass Correlation (ICC) and Kappa statistics. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach was applied to understanding integrative themes derived from the PRECIS-2 ratings and an end-of-study policy summit.ResultsThe ICCs for the composite ratings across the patient and provider-focused PRECIS-2 domains ranged from 0.77 to 0.87, and the Kappa values ranged from 0.25 to 0.37, reflecting overall fair-to-good interrater agreement for both trials. All four PRECIS-2 wheels were rated more pragmatic than explanatory, with composite mean and median scores ≥ 4. Across trials, the primary intent-to-treat analysis domain was consistently rated most pragmatic (mean = 5.0, SD = 0), while the follow-up/data collection domain was rated most explanatory (mean range = 3.14-3.43, SD range = 0.49-0.69). RAPICE field notes identified themes related to potential PRECIS-2 training improvements, as well as policy themes related to using trial data to inform US trauma care system practice change; the policy themes were not captured by the PRECIS-2 ratings.ConclusionsThe investigation documents that the PRECIS-2 and PRECIS-2-PS can be simultaneously used to feasibly and reliably characterize clinical trials with patient and provider-level targets. The integration of pragmatic and implementation science clinical trial research methods can be furthered by using common metrics such as the PRECIS-2 and PRECIS-2-PS. Future study could focus on clinical trial policy research methods development.Trial registrationDO-SBIS ClinicalTrials.gov NCT00607620. registered on January 29, 2008. TSOS ClinicalTrials.gov NCT02655354, registered on July 27, 2015.
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Project description:BackgroundThe after visit summary (AVS) is a paper or electronic document given to patients after a medical appointment, which is intended to summarize patients' health and guide future care, including self-management tasks.ObjectiveTo describe experiences of health systems implementing a redesigned outpatient AVS in commercially available electronic health record (EHR) systems to inform future optimization.Materials and methodsWe conducted semi-structured interviews with information technology and clinical leaders at 12 hospital and community-based healthcare institutions across the continental United States focusing on the process of AVS redesign and implementation. We also report our experience implementing a redesigned AVS in the Epic EHR at the Mount Sinai Hospital in New York City, NY.ResultsHealth systems experienced many challenges implementing the redesigned AVS. While many IT leaders noted that the redesigned AVS is easier to understand and the document is better organized, they claim the effort is time-consuming, Epic system upgrades render AVS modifications non-functional, and primary care and specialty practices have different needs in regards to content and formatting. Our team was able to modify the document by changing the order of print groups, modifying the font size, bolding section headers, and inserting page breaks. Similar to other health systems, our team found that it is difficult to achieve some desired features due to limitations in the EHR platform.ConclusionHealth IT leaders view the AVS as a valuable source of information for patients. However, limitations to AVS modifications in EHR systems present challenges to optimizing the tool. EHR vendors should incorporate learning from healthcare systems innovation efforts and consider building more flexibility into their product development.
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Project description:ObjectivesTo examine whether primary care outreach facilitation improves the quality of care for general practice patients from refugee backgrounds.DesignPragmatic, cluster randomised controlled trial, with stepped wedge allocation to early or late intervention groups.Setting, participants31 general practices in three metropolitan areas of Sydney and Melbourne with high levels of refugee resettlement, November 2017 - August 2019.InterventionTrained facilitators made three visits to practices over six months, using structured action plans to help practice teams optimise routines of refugee care.Major outcome measureChange in proportion of patients from refugee backgrounds with documented health assessments (Medicare billing). Secondary outcomes were refugee status recording, interpreter use, and clinician-perceived difficulty in referring patients to appropriate dental, social, settlement, and mental health services.ResultsOur sample comprised 14 633 patients. The intervention was associated with an increase in the proportion of patients with Medicare-billed health assessments during the preceding six months, from 19.1% (95% CI, 18.6-19.5%) to 27.3% (95% CI, 26.7-27.9%; odds ratio, 1.88; 95% CI, 1.42-2.50). The impact of the intervention was greater in smaller practices, practices with larger proportions of patients from refugee backgrounds, recent training in refugee health care, or higher baseline provision of health assessments for such patients. There was no impact on refugee status recording, interpreter use increased modestly, and reported difficulties in refugee-specific referrals to social, settlement and dental services were reduced.ConclusionsLow intensity practice facilitation may improve some aspects of primary care for people from refugee backgrounds. Facilitators employed by local health services could support integrated approaches to enhancing the quality of primary care for this vulnerable population.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001970235 (retrospective).
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Project description:ObjectivesThe Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts.DesignPragmatic cluster randomized trial.SettingA total of 86 primary care practices within 10 US healthcare systems.ParticipantsA total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries.MeasurementsStudy outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months.ResultsOver a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months.ConclusionCompletion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.
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Project description:BackgroundAustralia is one of many nations struggling with the challenges of delivering quality primary health care (PHC) to increasing numbers of refugees. The OPTIMISE project represents a collaboration between 12 organisations to generate a model of integrated refugee PHC suitable for uptake throughout Australia. This paper describes the methodology of one component; an outreach practice facilitation intervention, directed towards improving the quality of PHC received by refugees in Australian general practices.MethodsOur mixed methods study will use a cluster stepped wedge randomised controlled trial design set in 3 urban regions of high refugee resettlement in Australia. The intervention was build upon regional partnerships of policy advisors, clinicians, academics and health service managers. Following a regional needs assessment, the partnerships reached consensus on four core areas for intervention in general practice (GP): recording of refugee status; using interpreters; conducting comprehensive health assessments; and referring to refugee specialised services. Refugee health staff trained in outreach practice facilitation techniques will work with GP clinics to modify practice routines relating to the four core areas. 36 general practice clinics with no prior involvement in a refugee health focused practice facilitation will be randomly allocated into early and late intervention groups. The primary outcome will be changes in number of claims for Medical Benefit Service reimbursed comprehensive health assessments among patients identified as being from a refugee background. Changes in practice performance for this and 3 secondary outcomes will be evaluated using multilevel mixed effects models. Baseline data collection will comprise (i) pre-intervention provider survey; (ii) two surveys documenting each practices' structure and approaches to delivery of care to refugees. De-identified medical record data will be collected at baseline, at the end of the intervention and 6 and 12 months following completion.DiscussionOPTIMISE will test whether a regionally oriented practice facilitation initiative can improve the quality of PHC delivered to refugees. Findings have the potential to influence policy and practice in broader primary care settings.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001970235 , 05/12/2018, Retrospectively registered. Protocol Version 1, 21/08/2017.
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Project description:BACKGROUND: Summary measures of health that combine mortality and morbidity into a single indicator are being estimated in the Canadian context for approximately 200 diseases and conditions. To manage the large amount of data and calculations for this many diseases, we have developed a structured workbook system with easy to use tools. We expect this system will be attractive to researchers from other countries or regions of Canada who are interested in estimating the health-adjusted life years (HALYs) lost to premature mortality and year-equivalents lost to reduced functioning, as well as population attributable fractions (PAFs) associated with risk factors. This paper describes the workbook system using cancers as an example, and includes the entire system as a free, downloadable package. METHODS: The workbook system was developed in Excel and runs on a personal computer. It is a database system that stores data on population structure, mortality, incidence, distributions of cases entering a multitude of health states, durations of time spent in health states, preference scores that weight for severity, life table estimates of life expectancies, and risk factor prevalence and relative risks. The tools are Excel files with embedded macro programs. The main tool generates workbooks that estimate HALY, one per disease, by copying data from the database into a pre-defined template. Other tools summarize the HALY results across diseases for easy analysis. RESULTS: The downloadable zip file contains the database files initialized with Canadian data for cancers, the tools, templates and workbooks that estimate PAF and a user guide. The workbooks that estimate HALY are generated from the system at a rate of approximately one minute per disease. The resulting workbooks are self-contained and can be used directly to explore the details of a particular disease. Results can be discounted at different rates through simple parameter modification. CONCLUSION: The structured workbook approach offers researchers an efficient, easy to use, and easy to understand set of tools for estimating HALY and PAF summary measures for their country or region of interest.
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