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Non-pharmacological Pain Management After Surgery

NCT ID: NCT04570371

Last Updated: 2025-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81938 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-16

Study Completion Date

2024-05-02

Brief Summary

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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

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Conditions

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a stepped wedge cluster randomized pragmatic clinical trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Conversation Guide + Clinical Support

Intervention Type 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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Andrea Cheville

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea L Cheville

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35657564 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UG3AG067593

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-004839

Identifier Type: -

Identifier Source: org_study_id