NOHARM: Non-pharmacological Pain Management After Surgery

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04570371

Collaborator

National Institute on Aging (NIA) (NIH)

117,510

Enrollment

Locations

Arms

Anticipated Duration (Months)

58755

Patients Per Site

1468.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Procedure, Unspecified	Behavioral: Conversation Guide + Clinical Support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

117510 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a stepped wedge cluster randomized pragmatic clinical trial.This is a stepped wedge cluster randomized pragmatic clinical trial.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
2	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic
National Institute on Aging (NIA)

Investigators

Principal Investigator: Andrea L Cheville, Mayo Clinic

Study Documents (Full-Text)

Study Protocol - May 25, 2021

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Andrea Cheville, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04570371

Other Study ID Numbers:

20-004839
UG3AG067593

First Posted:

Sep 30, 2020

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 18, 2022