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 test an EHR-embedded, bundled intervention comprised of patient- and clinician-facing decision support components that enable patients to integrate nonpharmacologic pain care into their perioperative management. NOHARM will employ a stepped-wedge, cluster randomized pragmatic clinical trial design. Clusters throughout the Mayo Clinic Enterprise spanning 6 institutions in 4 states will participate. The NOHARM trial will evaluate whether pain and function, assessed with PROMIS tools, can be improved while honoring patient values and deemphasizing opioids in pain management.
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_A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
- News_NOHARM Explores Patients’ and Nurses’ Experiences With a Perioperative Nonpharmacologic Pain Care Education Program
November 20, 2025: NOHARM Explores Patients’ and Nurses’ Experiences With a Perioperative Nonpharmacologic Pain Care Education Program
- News_Initial Outcomes of the NOHARM Trial, in This Week’s Rethinking Clinical Trials Grand Rounds
July 23, 2025: Initial Outcomes of the NOHARM Trial, in This Week’s Rethinking Clinical Trials Grand Rounds
- News_A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
- News_Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations
November 26, 2024: Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations
- News_NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials
November 25, 2024: NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials
- 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
Publications
- Minteer et al BMC Complement Med Ther 2025
Patients' peri-operative experiences with non-pharmacologic pain care techniques: a secondary qualitative analysis of the NOHARM trial
- Minteer et al JMIR Nurs 2025
Delivering an electronic health record based educational intervention promoting peri-operative non-pharmacological pain care as part of a randomized controlled trial: Mixed method evaluation of inpatient nurses' perspectives
- Curtis et al Contemp Clin Trials 2025
Monitoring in pragmatic trials lessons from the NIH Pragmatic Trials Collaboratory
- Marsolo et al Contemp Clin Trials 2024
Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
- Cheville et al Appl Clin Inform 2024
Collection of patient-reported outcome measures in rural and underserved populations
- Zigler et al Contemp Clin Trials 2023
Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Boyd et al J Am Med Inform Assoc 2023
Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory
- 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
Presentations
- 00_Marsolo_combined_FINAL 2
Demystifying Data Sharing
- 00_George_Improving Implementation of Digital Tools_Final_Includes all slides
Improving Implementation of Digital Tools Developed in ePCTs
- 03_Cheville_NOHARM_Phase Zero Research Question
2024 NIH Workshop Session 1 Cheville
- 00_Weinfurt_Intro Slides_Phase Zero Research Question
2024 NIH Workshop Intro Session 1 Weinfurt Panel
- SC-Mtg-2024-Day2-Simon
Exploring the Generative Investment of an ePCT for Catalyzing Research
- 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