UH3 Project: Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM)
Overview
Principal Investigators:
Sponsoring Institution: Mayo Clinic Rochester
Collaborators:
- Mayo Clinic in Florida, Arizona, and the Upper Midwest
NIH Institute Providing Oversight: National Institute on Aging (NIA)
Program Official: Marcel Salive, MD, MPH (NIA)
Project Scientist: Theresa Cruz, PhD (National Institute of Child Health and Human Development [NICHD])
ClinicalTrials.gov Identifier: NCT04570371
Trial Status: Enrolling
Trial Summary
Prescriptions for narcotic pain relief after surgery result in unintended prolonged opioid use for hundreds of thousands of Americans. That trend fuels an excess supply of opioids that can lead to dependence, addiction, diversion, and overdoses on a national scale. Nonpharmacologic pain care is effective and recommended by guidelines for perioperative pain while offering a more favorable risk benefit ratio. However, nonpharmacologic pain care is rarely used as first- or second-line therapy after surgery. Patient and clinician decision support interventions are effective in encouraging patient-centered and guideline-concordant care, but these strategies have not been tested pragmatically as a bundle in everyday postoperative pain care.
The NOHARM trial will first confirm the feasibility of patient-facing as well as clinician-facing decision support components of an EHR-embedded evidence-based bundle (Aim 1). This will then be tested in a stepped-wedge, cluster-randomized trial in four health systems (Aim 2) affiliated with a national healthcare organization that uses a common EHR platform. The study will test a sustainable system strategy that could change the paradigm of perioperative pain management toward nonpharmacologic options in a manner that preserves patient function, honors patient values, and maintains availability of opioids as a last resort. Results could serve as a model for healthcare organizations nationally and could be disseminated through our institution’s ongoing partnership with the largest national EHR vendor. To ensure our approach is sustainable, the study will evaluate at all study sites what worked and what did not (Aim 3), focusing on high-risk patients within a parent organization that has expressed a high-level commitment to addressing the opioid crisis.
Data and Resource Sharing
- NOHARM-2021-UH3 Follow-up
NOHARM-Ethics and Regulatory UH3 Follow-up
- NOHARM-UG3-Minutes and Supplement_C
NOHARM Ethics and Regulatory Discussion
Featured Interviews
Drs. Cheville and Tilburt describe the pilot year of NOHARM, an NIH Collaboratory NIH Collaboratory Trial in the NIH HEAL Initiative’s PRISM portfolio.
News and Interviews
- News_Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
- News_Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
December 13, 2022: In Our Tenth Year, a Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
- Video_Update on the NOHARM Demonstration Project
Video Interview: Update on the NOHARM NIH Collaboratory Trial
- News_NOHARM Aims to Change How Patients Manage Pain After Surgery
May 25, 2022: NOHARM Aims to Change How Patients Manage Pain After Surgery
- News_NOHARM enrolls first participant
April 27, 2021: NOHARM Trial Enrolls First Participants in Study of Postoperative Pain Care
- News_Study Snapshots for PRISM Projects
January 11, 2021: Study Snapshots for Four PRISM UH3 Trials Are Available
- News_PRISM_Continuation
October 6, 2020: Four PRISM Trials Awarded Continuation from Planning to Implementation Phase
- Dr. Andrea Cheville Introduces the NOHARM Demonstration Project
Dr. Andrea Cheville Introduces the NOHARM Trial
- News_NOHARM to Test EHR-Embedded Clinical Decision Support for Postoperative Pain Care
March 5, 2020: NOHARM to Test EHR-Embedded Clinical Decision Support for Postoperative Pain Care: An Interview With Dr. Andrea Cheville
Publications
- Redmond et all Pain Ther 2022
NOHARM Study Design Paper
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- NOHARM Study Snapshot
NOHARM Study Snapshot
- Living Textbook Chapter_Clinical Decision Support
Living Textbook Chapter: Clinical Decision Support
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_How Are PRO Measures Used
Living Textbook: How are PRO Measures Used?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
Presentations
- SIO Presentation Tofthagen 14Sep2023
Normalizing Non-Pharmacological Pain Modalities in Perioperative Care: A Hands-On Case Study Workshop featuring NOHARM (an NIH HEAL Consortium and PRISM Initiative Pragmatic Trial)
- 2023_ARM_NOHARM Poster Minteer 26Jun2023
Evaluation of Patient Experiences As Part of the Pragmatic Non-Pharmacologic Options in Post-Operative Hospital-Based and Rehabilitation Pain Management (NOHARM) Trial
- NOHARM Poster_04May2023_23May2023
NOHARM Study Provides Non-Pharmacological Options to Managing Pain After Surgery
- Lifestyle Med Course - Complementary and Integrative Med Hein_Taylor 04Feb2023
Lifestyle Medicine and Role of Therapist
- Pain Mgt CNE Conference Hain_Cutshall 25Apr2023
Descriptive Results and Initial Progress of a HEAL-Funded Pragmatic Trial of Non-Pharmacological Perioperative Pain Care
- NOHARM ICIMH 2022_Tilburt
Doing NOHARM: Descriptive Results and Initial Progress of a HEAL-Funded Pragmatic Trial of Non-Pharmacological Perioperative Pain Care
- SC-Mtg-2023-Day2-Cheville-Tilburt
NOHARM Presentation 2023 Steering Committee meeting
- 2022 NIH Workshop_Panel 1
2022 NIH Workshop Panel 1 Presentation
- SC-Mtg-2022-Day-2-Cheville
NOHARM Presentation at 2022 Steering Committee Meeting
- Bringing an Implementation Mindset to Planning a PCT (DI 2020)
Bringing an Implementation Mindset to Planning a PCT (DI 2020)
- GR-Video-08-14-20
Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial (GR Video 2020)
- GR-Slides-08-14-20
Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial (GR Slides 2020)
- NOHARM_Cheville_Tilburt_PRISM Kickoff_Final1
Drs. Andrea Cheville and Jon Tilburt introduce NOHARM at the PRISM Kickoff Meeting