Non-pharmacological Pain Management After Surgery

Not Applicable

Active, not recruiting

• Conditions: Surgical Procedure, Unspecified
• Interventions: Behavioral: Conversation Guide + Clinical Support

• Registration Number: NCT04570371
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-09-30
• Study Start: 2021-03-01
• Primary Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86726

Inclusion Criteria

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

Read More

Exclusion Criteria

• Patients under 18 years of age.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Conversation Guide + Clinical Support	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States