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Incentives and payments in pragmatic clinical trials: scientific, ethical, and policy considerations11/12/2021Publication from the Ethics and Regulatory CoreAndrew Garland; Kevin Weinfurt; Jeremy Sugarman
A prospective US national trauma center study of firearm injury survivors weapon carriage and posttraumatic stress disorder symptoms10/1/2021Publication from the TSOS Demonstration ProjectsDeepika Nehra; Eileen Bulger; Ronald Maier; Kathleen Moloney; Joan Russo; Jin Wang; Kristina Anderson; Douglas Zatzick
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory10/1/2021Publication from the Electronic Health Records CoreRachel Richesson; Keith Marsolo; Brian Douthit; Karen Staman; Michael Ho; Dana Dailey; Andrew Boyd; Kathleen McTigue; Miriam Ezenwa; Judith Schlaeger; Crystal Patil; Keturah Faurot; Leah Tuzzio; Eric Larson; Emily O'Brien; Christina Zigler; Joshua Lakin; Alice Pressman; Jordan Braciszewski; Corita Grudzen; Guilherme Del Fiol
MOTIFS Publication: Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research9/29/2021Publication from the MOTIFS supplementStephanie Morain; Debra Mathews; Gail Geller; Juli Bollinger; Kevin Weinfurt; Jeffrey Jarvik; Elizabeth May; Jeremy Sugarman
Patient, provider, and clinic characteristics associated with opioid and non-opioid pain prescriptions for patients receiving low back imaging in primary care9/19/2021Publication from the LIRE Demonstration ProjectLaura Gold; Zachary Marcum; Eric Meier; Judith Turner; Kathryn James; David Kallmes; Patrick Luetmer; Brent Griffith; Karen Sherman; Janna Friedly; Pradeep Suri; Richard Deyo; Sandra Johnston; Andrew Avins; Patrick Heagerty; Jeffrey Jarvik
OPTIMUM Study Design Paper8/27/2021OPTIMUM Study Design PaperCarol Greco; Susan Gaylord; Kim Faurot; Janice Weinberg; Paula Gardiner; Isabel Roth; Jessica Barnhill; Holly Thomas; Sayali Dhamne; Christine Lathren; Jose Baez; Suzanne Lawrence; Tuhina Neogi; Karen Lasser; Maria Castro; Anna Marie White; Sandra Jean Simmons; Cleopatra Ferrao; Dhanesh Binda; Nandie Elhadidy; Kelly Eason; Kathleen McTigue; Natalia Morone
Zelen design clinical trials: why, when, and how8/17/2021Publication from the SPOT Demonstration ProjectGregory Simon; Susan Shortreed; Lynn DeBar
MOTIFS Publication: Patients' reactions to letters communicating collateral findings of pragmatic clinical trials: a national web-based survey8/12/2021Publication from the MOTIFS supplementKevin Weinfurt; Juli Bollinger; Elizabeth May; Gail Geller; Debra Mathews; Stephanie Morain; Lorrie Schmid; Diane Bloom; Jeremy Sugarman
Nudge Study Design Paper8/11/2021Nudge Study Design PaperRussell Glasgow; Christopher Knoepke; David Magid; Gary Grunwald; Thomas Glorioso; Joy Waughtal; Joel Marrs; Sheana Bull; Michael Ho
The association between perceived electronic health record usability and professional burnout among US nurses7/30/2021Publication from the EMBED Demonstration ProjectEdward Melnick; Colin West; Bidisha Nath; Pamela Cipriano; Cheryl Peterson; Daniel Satele; Tait Shanafelt; Liselotte Dyrbye
Is learning worth the trouble? Improving health care system participation in embedded research6/26/2021Publication from the Coordinating CenterRichard Platt; Gregory Simon; Adrian Hernandez
Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies6/24/2021Publication from the Health Care Systems Interactions CoreLeah Tuzzio; Catherine Meyers; Laura Dember; Corita Grudzen; Edward Melnick; Karen Staman; Susan Huang; Julie Richards; Lynn DeBar; Miguel Vazquez; Beverly Green; Gloria Coronado; Jeffrey Jarvik; Michael Ho; Barbara Wells; Kathryn James; Eric Larson
Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study6/3/2021Publication from the GRACE Demonstration ProjectRobert Molokie; Judith Schlaeger; Hongjin Li; Crystal Patil; Franklin Njoku; Alana Steffen; Ardith Doorenbos
Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews6/3/2021Publication from the Nudge Demonstration ProjectJoy Waughtal; Phat Luong; Catia Chavez; Michael Ho; Sheana Bull
Acupuncture intervention protocol: consensus process for a pragmatic randomized controlled trial of acupuncture for management of chronic low back pain in older adults: an NIH Heal Initiative funded project5/26/2021Publication from the BackInAction Demonstration ProjectKaren Sherman; Arja Nielsen; Laura Ocker; Iman Majd; Jeff Draisin; Katherine Taromina; Marjorie Maggenti; Jaimie Long; Mark Nolting
Text nessage medication adherence reminders automated and delivered at scale across two institutions: testing the Nudge system: pilot study5/17/2021Publication from the Nudge Demonstration ProjectPhat Luong; Larry Allen; Joy Waughtal; Lisa Sandy; Michael Ho; Sheana Bull; Thomas Glorioso; Gary Grunwald; Pamela Peterson; Amber Khanna
A yet unrealized promise: structured advance care planning elements in the electronic health record4/7/2021Publication from the ACP PEACE Demonstration ProjectJoshua Lakin; Daniel Gundersen; Charlotta Lindvall; Michael Paasche-Orlow; James Tulsky; Elise Brannen; Angelo Volandes; Kathryn Pollak; Danielle Kennedy; Jody-Ann McLeggon; Jeremiah Stout
Emergency department visits for nonfatal opioid overdose during the COVID-19 pandemic across 6 US healthcare systems3/18/2021Publication from the EMBED Demonstration ProjectWilliam Soares; Edward Melnick; Bidisha Nath; Gail D'Onofrio; Hyung Paek; Rachel Skains; Jason Hoppe; Molly Jeffery; Lauren Walter; Martin Casey; Anthony Napoli
Reconciling statistical and clinicians' predictions of suicide risk3/11/2021Publication from the SPOT Demonstration ProjectGregory Simon; Bridget Matarazzo; Colin Walsh; Jordan Smoller; Edwin Boudreaux; Bobbi Yarborough; Susan Shortreed; R. Yates Coley; Brian Ahmedani; Riddhi Doshi; Leah Harris; Michael Schoenbaum
TSOS Main Outcome Paper3/10/2021TSOS Main Outcome PaperDouglas Zatzick; Gregory Jurkovich; Patrick Heagerty; Joan Russo; Doyanne Darnell; Lea Parker; Michelle Roberts; Rddhi Moodliar; Allison Engstrom; Eileen Bulger; Lauren Whiteside; Deepika Nehra; Lawrence Palinkas; Kathleen Moloney; Jin Wang; Ronald Maier
Clinical outcomes of patients hospitalized with coronavirus disease 2019 (COVID-19) in Boston2/24/2021Publication from the ACP PEACE Demonstration ProjectAreej El-Jawahri; Michael Paasche-Orlow; Joshua Lakin; Annemarie Forrest; Elise Brannen; Angelo Volandes; Hacho Bohossian; Connor Johnson; Zara Cooper; Annemarie Jagielo; Matthew Reynolds; Kathleen Coogan; Dagny Vaughn
Leveraging a health information exchange to examine the accuracy of self-report emergency department utilization data among hospitalized injury survivors1/28/2021Publication from the TSOS Demonstration ProjectLauren Whiteside; Joan Russo; Deepika Nehra; Kathleen Moloney; Douglas Zatzick; Marie Vrablik; Eileen Bulger
Antidopaminergic-antiparkinsonian medication prescribing cascade in persons with Alzheimer's disease1/11/2021Publication from the Distributed Research Network ADRD supplementSonal Singh; Noelle Cocoros; Kevin Haynes; Vinit Nair; Paula Rochon; Richard Platt; Sarah Bloomstone; Kathryn Anzuoni; Jerry Gurwitz; Thomas Harkins; Inna Dashevsky; Juliane Reynolds; Kathleen Mazor; Sybil Crawford
Perceived electronic health record usability as a predictor of task load and burnout among US physicians: mediation analysis12/22/2020Publication from the EMBED Demonstration ProjectEdward Melnick; Elizabeth Harry; Christine Sinsky; Liselotte Dyrbye; Hanhan Wang; Mickey Todd Trockel; Colin West; Tait Shanafelt
HiLo Study Design Paper12/3/2020HiLo Study Design PaperDaniel Edmonston; Laura Dember; Hrishikesh Chakraborty; Myles Wolf
Reduction in movement-evoked pain and fatigue during initial 30-minute TENS treatment predicts TENS responders in women with fibromyalgia11/11/2020Publication from the FM-TIPS Demonstration ProjectLeslie Crofford; Kathleen Sluka; Carol Vance; Bridget Zimmerman; Dana Dailey; Barbara Rakel; Katharine Geasland; Ruth Chimenti; Jon Williams; Meenakshi Golchha
Impact of an advance care planning video intervention on care of short-stay nursing home patients11/7/2020Publication from the PROVEN Demonstration ProjectLacey Loomer; Jessica Ogarek; Susan Mitchell; Angelo Volandes; Roee Gutman; Pedro Gozalo; Ellen McCreedy; Vincent Mor
Factors influencing implementation of a colorectal cancer screening improvement program in community health centers: an applied use of configurational comparative methods11/1/2020Publication from the STOP CRC Demonstration ProjectAmanda Petrik; Beverly Green; Jennifer Coury; Gloria Coronado; Jennifer Schneider; Edward Miech
Effectiveness and reach of the Primary Palliative Care for Emergency Medicine (PRIM-ER) Pilot Study: a qualitative analysis10/27/2020Publication from the PRIM-ER Demonstration ProjectFrank Chung; Sarah Turecamo; Allison Cuthel; Corita Grudzen
Rapid ethnographic assessment of the COVID-19 pandemic April 2020 'surge' and its impact on service delivery in an acute care medical emergency department and trauma center10/20/2020Publication from the TSOS Demonstration ProjectLawrence Palinkas; Lauren Whiteside; Deepika Nehra; Allison Engstrom; Mark Taylor; Kathleen Moloney; Douglas Zatzick
ACP PEACE Study Redesign (Details)10/7/2020This document describes changes to the ACP PEACE stepped-wedge study design to address effects caused by the onset of COVID-19.Angelo Volandes; James Tulsky
Estimating the Number of Self-Harm Events Not Identified by Encounter Diagnoses in Health Records9/25/2020Preprint from the SPOT Demonstration ProjectGregory Simon; Susan Shortreed; Jennifer Boggs; Gregory Clarke; Rebecca Rossom; Julie Richards; Arne Beck
Disseminating trial results: we can have both faster and better9/24/2020Publication from the NIH Collaboratory Coordinating CenterGregory Simon; Rachel Richesson; Adrian Hernandez
Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight 9/16/2020Publication from the TSOS Demonstration Project and the Ethics and Regulatory CoreDouglas Zatzick; Michelle Roberts; Dylan Fisher; Lea Parker; Doyanne Darnell; Jeremy Sugarman; Judith Carrithers; Kevin Weinfurt; Gregory Jurkovich
Identifying multisite chronic pain with electronic health records data9/11/2020Publication from the PPACT Demonstration ProjectLynn DeBar; Richard Deyo; Meghan Mayhew; Robert Kerns; Cynthia Brandt; Michael Von Korff; Joseph Goulet
LIRE Main Outcome Paper9/4/2020LIRE Main Outcome PaperJeffrey Jarvik; Eric Meier; Kathryn James; Laura Gold; Katherine Tan; Larry Kessler; Pradeep Suri; David Kallmes; Daniel Cherkin; Richard Deyo; Karen Sherman; Safwan Halabi; Bryan Comstock; Patrick Luetmer; Andrew Avins; Sean Rundell; Brent Griffith; Janna Friedly; Danielle Lavallee; Kari Stephens; Judith Turner; Brian Bresnahan; Patrick Heagerty
The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises9/1/2020Publication from the FM-TIPS Demonstration ProjectKathleen Sluka; Srinivasa Raja; Daniel Carr; Milton Cohen; Nanna Finnerup; Herta Flor; Stephen Gibson; Francis Keefe; Jeffrey Mogil; Matthias Ringkamp; Xue-Jun Song; Bonnie Stevens; Mark Sullivan; Perri Tutelman; Takahiro Ushida; Kyle Vader
MOTIFS Publication: Stakeholder perspectives regarding pragmatic clinical trial collateral findings8/28/2020Publication from the MOTIFS supplementStephanie Morain; Stephanie Startz; Debra Mathews; Kevin Weinfurt; Elizabeth May; Juli Bollinger; Gail Geller; Jeremy Sugarman
Diversity Supplement Publication: Sample size requirements for detecting treatment effect heterogeneity in cluster randomized trials8/21/2020Publication from the Diversity supplementMonique Anderson; Adrian Hernandez; Robert Mentz; Siyun Yang; Kingshuk Choudhury
MOTIFS Publication: Patients' views about the disclosure of collateral findings in pragmatic clinical trials: a focus group study8/19/2020Publication from the MOTIFS supplementJuli Bollinger; Kevin Weinfurt; Jeremy Sugarman; Gail Geller; Elizabeth May; Stephanie Morain; Debra Mathews
A pragmatic approach to psychometric comparisons between the DSM-IV and DSM-5 Posttraumatic Stress Disorder (PTSD) Checklists in acutely injured trauma patients8/6/2020Publication from the TSOS Demonstration ProjectDouglas Zatzick; Rddhi Moodliar; Joan Russo; Michele Bedard-Gilligan; Kathleen Moloney; Peyton Johnson; Sara Seo; Natalie Viziri
Trends in emergency department visits and hospital admissions in health care systems in 5 states in the first months of the COVID-19 pandemic in the US8/3/2020Publication from the EMBED Demonstration ProjectEdward Melnick; Gail D'Onofrio; Molly Jeffery; Hyung Paek; Timothy Platts-Mills; William Soares; Jason Hoppe; Nicholas Genes; Bidisha Nath
ADAPTABLE Supplement Publication: Applying patient-reported outcome methodology to capture patient-reported health data: report from an NIH Collaboratory roundtable7/16/2020Publication from the ADAPTABLE SupplementKevin Weinfurt; Lesley Curtis; Antonia Bennett; Mattias Jonsson; Ronald Chen; Sana Al-Khatib
ACP PEACE Study Design Paper7/6/2020ACP PEACE Study Design PaperJames Tulsky; Angelo Volandes; Joshua Lakin; Elise Brannen; Michael Paasche-Orlow; Charlotta Lindvall; Yuchiao Chang; Daniel Gundersen; Areej El-Jawahri
Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: an overview7/6/2020Publication from the EMBED Demonstration ProjectFan Li; Edward Melnick; Patrick Heagerty; James Hughes; Karla Hemming; Monica Taljaard
PROVEN Main Outcome Paper7/6/2020PROVEN Main Outcome PaperSusan Mitchell; Angelo Volandes; Roee Gutman; Lacey Loomer; Ellen McCreedy; Vincent Mor; Pedro Gozalo; Jessica Ogarek; Ruoshui Zhai
Diagnosed prevalence of Alzheimer's disease and related dementias in Medicare Advantage plans7/5/2020Publication from the Distributed Research Network's ADRD SupplementEric Jutkowitz; Julie Bynum; Susan Mitchell; Noelle Cocoros; Oren Shapira; Kevin Haynes; Vinit Nair; Cheryl McMahill-Walraven; Richard Platt; Ellen McCarthy
Certificates of confidentiality and unexpected complications for pragmatic clinical trials6/24/2020Publication from the Ethics and Regulatory CoreJudith Carrithers; Jeremy Sugarman
Commentary: Right truncation in cluster randomized trials can attenuate the power of a marginal analysis6/1/2020Publication from the EMBED Demonstration ProjectFan Li
Association of perceived electronic health record usability with patient interactions and work-life integration among US physicians6/1/2020Publication from the EMBED Demonstration ProjectEdward Melnick
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