Non-pharmacological Pain Management After Surgery (NOHARM)

Mayo Clinic

Status: Completed

Conditions: Surgical Procedure, Unspecified

Treatments: Behavioral: Conversation Guide + Clinical Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04570371

UG3AG067593 (U.S. NIH Grant/Contract)

20-004839

Details and patient eligibility

About

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.

Enrollment: 81,938 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81,938 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Conversation Guide + Clinical Support

Control Arm

No Intervention group

Description:

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).