Non-pharmacological Pain Management After Surgery

NCT04570371 | Completed Results

• 2 other identifiers: 20-004839UG3AG067593
• Study Type: interventional
• Target: 81,938
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (5)

• 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

• Use of Non-Pharmacological Pain Control Modalities

  Number of participants using Non-Pharmacological Pain Control Modalities

  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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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).

Interventions

Conversation Guide + Clinical Support BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Patients under 18 years of age.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 35657564 DERIVED

Results Point of Contact

• Title: Dr. Andrea Cheville
• Organization: Mayo Clinic

cheville.andrea@mayo.edu

(507) 284-2747

Study Officials

• Andrea L Cheville

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a stepped wedge cluster randomized pragmatic clinical trial.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: September 30, 2020
• Study Start: October 16, 2020
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)