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An integrated web application for decision support and automation of EHR workflow: a case study of current challenges to standards-based messaging and scalability from the EMBED trial10/22/2019Publication from the EMBED Demonstration ProjectEdward Melnick
Addressing guideline and policy changes during pragmatic clinical trials8/1/2019Addressing guideline and policy changes during pragmatic clinical trialsLesley Curtis; Laura Dember; Miguel Vazquez; David Murray; Lynn DeBar; Karen Staman; Ed Septimus; Vincent Mor; Angelo Volandes; Barbara Wells; Susan Huang; Beverly Green; Gloria Coronado; Catherine Meyers; Leah Tuzzio; Adrian Hernandez; Jeremy Sugarman
Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting7/29/2019Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home settingJennifer Palmer; Victoria Parker; Vincent Mor; Angelo Volandes; Lacey Barre; Emmanuelle Belanger; Phoebe Carter; Lacey Loomer; Ellen McCreedy; Susan Mitchell
Pragmatic clinical trials offer unique opportunities for disseminating, implementing, and sustaining evidence-based practices into clinical care: Proceedings of a workshop12/26/2018The Collaboratory hosted a workshop to explore challenges and strategies for the dissemination, implementation, and sustainability of findings from pragmatic clinical trials (PCTs) embedded in HC systems.Leah Tuzzio; Eric Larson; David Chambers; Gloria Coronado; Lesley Curtis; Wendy Weber; Douglas Zatzick; Catherine Meyers
Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) in Pragmatic Clinical Trials of Mental Health Services Implementation: Methods and Applied Case Study11/28/2018From the abstract: "This paper introduces a qualitative method known as Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) that combines the techniques of Rapid Assessment Procedures with clinical ethnography."Lawrence Palinkas; Douglas Zatzick
Task-shifting to improve the reach of mental health interventions for trauma patients: findings from a pilot study of trauma nurse training in patient-centered activity scheduling for PTSD and depression11/20/2018This article reports on a pilot study that assessed the feasibility of training trauma nurses to engage patients in patient-centered activity scheduling.Doyanne Darnell; Douglas Zatzick
Two Medicaid health plans' models and motivations for improving colorectal cancer screening rates11/16/2018Two Medicaid health plans' models and motivations for improving colorectal cancer screening rates
Comparison of Natural Language Processing Rules-based and Machine-learning Systems to Identify Lumbar Spine Imaging Findings Related to Low Back Pain11/15/2018Investigators from the LIRE trial evaluate a natural language processing (NLP) system for identification of lumbar spine imaging findings related to low back pain on magnetic resonance and x-ray radiology reports.Katherine Tan; Patrick Heagerty; Jeffrey Jarvik
Cancer Screening Results and Follow-up Using Routinely Collected Electronic Health Data: Estimates for Breast, Colon, and Cervical Cancer Screenings10/28/2018In this article, the Collaboratory DRN is used to evaluate over 100 million person years of curated claims data to assess new rates and follow-up procedures for colorectal, breast, and cervical cancer.Jeffrey Brown; Lesley Curtis; Richard Platt
Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial10/17/2018STOP CRC investigators compare the effectiveness of two phone-based approaches to mailed FIT outreach reminders.Carrie Nielson; Amanda Petrik; Gloria Coronado
Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial9/1/2018Effectiveness of a mailed colorectal cancer screening outreach program in community health clinics: the STOP CRC cluster randomized clinical trialGloria Coronado; Amanda Petrik; William Vollmer; Beverly Green
A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems8/22/2018PROVEN's protocol is assessed according to the three PRECIS-2 domains pertinent to implementation.Jennifer Palmer; Vincent Mor; Angelo Volandes; Ellen McCreedy; Susan Mitchell
Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial8/13/2018Article from STOP CRC team on predictive values of fecal immunochemical testsGloria Coronado; Carrie Nielson; Amanda Petrik; William Vollmer; Beverly Green
An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes.5/24/2018This article discusses statistical properties of model-based and randomization-based tests under both simple and constrained randomization designs, with varying degrees of analysis-based covariate adjustment.Liz Turner
Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research5/4/2018This artice describes the infrastructure designed to automate patient-reported outcome (PRO) data collection for PPACT.Ashli Owen-Smith; Lynn DeBar
Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.4/14/2018Protocol paper for PPACTLynn DeBar; Ashli Owen-Smith; William Vollmer
Identifying and Supporting Nonpharmacological Dementia Interventions Ready for Pragmatic Trials: Results From an Expert Workshop4/13/2018The authors chaired a workshop in December 2017 to discuss a national framework for supporting pragmatic trials of nonpharmacologic dementia interventions.Rosa Baier; Susan Mitchell; Angelo Volandes; Vincent Mor
Representation in the Care Planning Process for Nursing Home Residents With Dementia4/4/2018This study measured family member participation in nursing home care planning.Ellen McCreedy; Susan Mitchell; Angelo Volandes; Vincent Mor
Using Natural Language Processing of Free-Text Radiology Reports to Identify Type 1 Modic Endplate Changes2/15/2018From the abstract: "Our goal was to determine the feasibility of using natural language processing (NLP) to identify patients with Type 1 Modic endplate changes using clinical reports of magnetic resonance (MR) imaging examinations of the spine."Jeffrey Jarvik; Patrick Heagerty; Hannu Huhdanpaa
Predictors of Colorectal Cancer Screening Prior to Implementation of a Large Pragmatic Trial in Federally Qualified Health Centers2/14/2018From the abstract: "We examined patient-level and neighborhood-level characteristics associated with being up to date with colorectal cancer screening guidelines."Amanda Petrik; Beverly Green; William Vollmer; Gloria Coronado
Effect of Reminding Patients to Complete Fecal Immunochemical Testing: A Comparative Effectiveness Study of Automated and Live Approaches1/12/2018The STOP CRC investigators compared the effect different reminders (phone call, text messages) had on completion rates for FIT tests. Gloria Coronado; Amanda Petrik; William Vollmer
Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices11/11/2017The authors conducted surveys to measure respondents' reacions to hypothetical research scenarios. Measures included williningness to participate and acceptability of the notification and authorization approaches.Kevin Weinfurt; Juli Bollinger; Rachel Topazian; Jeremy Sugarman
Data Sharing and Embedded Research11/7/2017In this article, Simon et al argue that strict data sharing requirements might dissuade health care systems from participating in embedded pragmatic research.Gregory Simon; Gloria Coronado; Lynn DeBar; Laura Dember; Beverly Green; Susan Huang; Jeffrey Jarvik; Vincent Mor; Joakim Ramsberg; Ed Septimus; Karen Staman; Miguel Vazquez; William Vollmer; Douglas Zatzick; Adrian Hernandez; Richard Platt
An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes10/30/2017This article discusses statistical properties of model-based and randomization-based tests under both simple and constrained randomization designs, with varying degrees of analysis-based covariate adjustment.Liz Turner; Fan Li; Patrick Heagerty; David Murray; William Vollmer; Elizabeth DeLong
Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach10/11/2017The authors assessed how specific attributes of pragmatic dialysis trials influenced patients' and physicians' willingness to have their dialysis facility participate in a hypothetical trial of hypertension management.Susan Ellenberg; Laura Dember; Katherine Courtright
Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory10/6/2017This article contains lessons learned from the first four years of the Collaboratory and experiences with the Demonstration Projects.  The authors highlight some of the challenges encountered and solutions developed.Kevin Weinfurt; Karen Staman; Adrian Hernandez; Gloria Coronado; Lynn DeBar; Laura Dember; Beverly Green; Patrick Heagerty; Susan Huang; Jeffrey Jarvik; Eric Larson; Vincent Mor; Gary Rosenthal; Richard Platt; Ed Septimus; Gregory Simon; Jeremy Sugarman; Miguel Vazquez; Douglas Zatzick; Lesley Curtis
Implementation successes and challenges in participating in a pragmatic study to improve colon cancer screening: perspectives of health center leaders9/7/2017The authors report on implementation challenges faced by the eight community health centers that participated in STOP CRC.Gloria Coronado; Beverly Green; Amanda Petrik
Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory9/1/2017Richesson et al present four broad categories of informatics-related challenges in pragmatic clinical trials.Rachel Richesson; Beverly Green; Reesa Laws; Michelle Smerek; Meredith Zozus; Ed Hammond; Kari Stephens; Gregory Simon; Jon Puro; Eric Van Eaton
Applying the Plan-Do-Study-Act (PDSA) approach to a large pragmatic study involving safety net clinics6/19/2017STOP CRC investigators used a Plan-Do-Study-Act (PDSA) cycle  to optimize the research implementation of an automated colon cancer screening outreach program in intervention clinics.Gloria Coronado; Beverly Green; Jennifer Coury
Mapping multi-site clinic workflows to design systems-enabled interventions6/14/2017Article on clinic work flow for STOP CRCGloria Coronado
Case Studies from the Clinic: Initiating and Implementing Patient-Reported Outcome Measures6/12/2017The authors describe first-hand experiences regarding the incorporation of patient-reported outcomes for both care and research.Lynn DeBar; Douglas Zatzick; Karen Staman; Amy Abernethy; Kevin Weinfurt; Tracie Locklear
The Cumulative Burden of Mental, Substance Use, and General Medical Disorders and Rehospitalization and Mortality After an Injury6/1/2017From the abstract: "This study of patients hospitalized for an injury assessed associations between comorbid mental, substance use, and general medical disorders, TBI, and violent events or suicide attempts and recurrent hospitalization and death."Douglas Zatzick; Doyanne Darnell
Assessing electronic health record phenotypes against gold-standard diagnostic criteria for diabetes mellitus4/15/2017From the abstract: "We assessed the sensitivity and specificity of 8 electronic health record (EHR)-based phenotypes for diabetes mellitus against gold-standard American Diabetes Association (ADA) diagnostic criteria via chart review by clinical experts."Rachel Richesson; Shelley Rusincovitch; Susan Spratt
PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting4/14/2017Design and rationale paper for the PROVEN trialVincent Mor; Angelo Volandes; Susan Mitchell
Changes in Coding of Suicide Attempts or Self-Harm With Transition From ICD-9 to ICD-103/15/2017Changes in Coding of Suicide Attempts or Self-Harm With Transition From ICD-9 to ICD-10Gregory Simon; Christine Stewart
The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics12/6/2016As part of the STOP CRC study, the authors assessed the accuracy of EHR codes in identifying patients eligible for CRC screening.Beverly Green; William Vollmer; Gloria Coronado; Amanda Petrik
Patients' Views Concerning Research on Medical Practices: Implications for Consent11/16/2016The authors convened focus groups to discuss hypothetical research studies and potential methods of notifying patients and obtaining their authorization to participate.Kevin Weinfurt; Nancy Kass; Laura Beskow; Jeremy Sugarman
Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative10/27/2016Experience from the TiME Trial illustrates challenges and solutions to operational, ethical, and regulatory issues of pragmatic trials in the nephrology setting.Laura Dember; Eric Larson
Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core10/13/2016This article describes methodological issues that arose across five of the Demonstration Projects of the Collaboratory, as well as considerations for cross-over and stepped-wedge designs.Andrea Cook; Elizabeth DeLong; David Murray; William Vollmer; Patrick Heagerty
Trials Without Tribulations: Minimizing the Burden of Pragmatic Research on Healthcare Systems9/1/2016In an article in Healthcare, Eric Larson, MD, MPH, and colleagues present advice based on case studies from the NIH CollaboratoryEric Larson; Gloria Coronado
Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial8/16/2016Protocol paper for SPOTGregory Simon
Timeliness of follow-up to a positive fecal immunochemical test result among community health center patients8/9/2016Journal article on the timeliness of follow-up for a positive FIT test from the STOP CRC teamGloria Coronado; Ann Oluloro
Physicians' perspectives regarding pragmatic clinical trials8/5/2016In this article, the authors identify physicians' perspectives related to participating in pragmatic clinical trialsRachel Topazian; Kevin Weinfurt; Jeremy Sugarman
Timeliness of Colonoscopy After Abnormal Fecal Test Results in a Safety Net Practice8/4/2016STOP CRC investigators examined factors associated with adherence to follow-up colonoscopy among patients with abnormal fecal test results.Ann Oluloro; Amanda Petrik; Gloria Coronado
Research Reproducibility in Longitudinal Multi-Center Studies Using Data from Electronic Health Records7/20/2016The authors identify specific project features that drive requirements for research reproducibility.Meredith Zozus; Rachel Richesson; Ed Hammond
Clinical phenotyping in selected national networks: demonstrating the need for high-throughput, portable, and computational methods7/7/2016This article summarizes broad approaches to clinical phenotyping and highlights the important role of these networks in the progression of high-throughput phenotyping and precision medicine. Rachel Richesson; Michelle Smerek; Blake Cameron
A Framework to Support the Sharing and Reuse of Computable Phenotype Definitions Across Health Care Delivery and Clinical Research Applications7/5/2016The authors articulate a framework to support the sharing of phenotype definitions across research and health care use cases, and highlight gaps and areas that need attention and collaborative solutions.Rachel Richesson; Blake Cameron; Michelle Smerek
An evaluation of constrained randomization for the design and analysis of group-randomized trials5/10/2016The authors used simulations to evaluate key statistical issues with constrained randomization.Fan Li; David Murray; Patrick Heagerty; Elizabeth DeLong
An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity4/20/2016This article describes the implementation science conceptual frameworks used to evaluate the uptake of the intervention in TSOS.Douglas Zatzick; Doyanne Darnell; Patrick Heagerty; Gregory Jurkovich; David Chambers
Recruiting community health centers into pragmatic research: Findings from STOP CRC4/12/2016As part of the STOP CRC study, the authors evaluated methods for raising the rates for colorectal cancer screeing in eight community health centers.Gloria Coronado; Beverly Green
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