Non-pharmacological Pain Management After Surgery (NOHARM)

March 14, 2024 updated by: Andrea Cheville, Mayo Clinic

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86726

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
PROMIS-CAT Pain
Time Frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Change in patient reported pain; measured on scale of 1-100
Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
PROMIS-CAT Physical Function
Time Frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Change in patient reported Physical Function; measured on scale of 1-100
Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
PROMIS-CAT Physical Anxiety
Time Frame: Baseline (before hospital discharge), 3-Months Post-Surgery
Change in patient reported Anxiety; measured on scale of 1-100
Baseline (before hospital discharge), 3-Months Post-Surgery
Use of Non-Pharmacological Pain Control Modalities
Time Frame: 3 Months Post-Surgery
Number of participants using Non-Pharmacological Pain Control Modalities
3 Months Post-Surgery
Opioid Use
Time Frame: 3-Months Post-Surgery
Total amount of opioid pain medication used after surgery
3-Months Post-Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Andrea L Cheville, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

January 31, 2024

Study Completion (Estimated)

July 1, 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 (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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