Non-pharmacological Pain Management After Surgery (NOHARM)

Non-Pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management: The NOHARM Trial

The purpose of this study is to test the impact of a bundled NOHARM Conversation Guide with clinical decision support intervention embedded within an Electronic Health Record (EHR) on pain and function 3 months following surgery.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Behavioral: Conversation Guide + Clinical Support

• Study Type: Interventional
• Enrollment (Actual): 81938
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients 18 years of age and older.
• Must be undergoing qualifying surgeries at participating sites.
• Patients under 18 years of age.

Exclusion Criteria:

- Patients under 18 years of age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches in which the intervention will be implemented per the study schedule.	Behavioral: Conversation Guide + Clinical Support; The intervention is a bundled intervention (conversation guide + clinician decision support tools) which promotes the solicitation and use of patient preferences for post-surgical, non-pharmacological pain management strategies.
No Intervention: Control Arm; Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches. The control arm consists of all patients receiving surgery in implementation tranches in which the intervention has not been implemented yet (per the study schedule).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Non-Pharmacological Pain Control Modalities	Number of participants using Non-Pharmacological Pain Control Modalities	3 Months Post-Surgery
PROMIS-CAT Pain	Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.	Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
PROMIS-CAT Physical Function	Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome.	Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
PROMIS-CAT Anxiety	Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome.	Baseline (before hospital discharge), 3-Months Post-Surgery
Opioid Use	Binary variables indicating presence or absence of opioid administration and prescription during the hospital encounter associated with the index surgery and during the post-discharge follow-up period.	3-Months Post-Surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Andrea L Cheville, Mayo Clinic

Publications and helpful links

General Publications

• Redmond S; Mayo Clinic NOHARM Research Team; Tilburt J, Cheville A. Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial. Pain Ther. 2022 Sep;11(3):1037-1053. doi: 10.1007/s40122-022-00393-x. Epub 2022 Jun 3.

Helpful Links

• Mayo Clinic Clinical Trials (Disabled post trial)

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20-004839; UG3AG067593 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No