NCT04336592

Brief Summary

Researchers are promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure at Mayo Clinic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 13, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

April 3, 2020

Last Update Submit

August 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non-Pharmacological options participation

    Number of participants to complete the non-pharmacological options in post-operative Hospital and Rehabilitative Management

    1 month post-operative

Study Arms (2)

Patients

Patients scheduled to receive a surgical spine procedure at Mayo Clinic

Behavioral: Non-pharmacological Options in post-operative Hospital and Rehabilitative Management (NOHARM)

Clinicians

Surgeons, Physician pain specialists and allied health caring for participating patients

Behavioral: Non-pharmacological Options in post-operative Hospital and Rehabilitative Management (NOHARM)

Interventions

Gathers patient preferences for non-pharmacological pain management strategies through medical record and inform clinicians (via prompts, orders, etc.) of these preferences and encourages conversation about these preferences throughout their routine pre- and post-surgical interactions with patients. Resources will be provided to bedside clinicians as they assist patients in identifying a personalized post-discharge pain management strategy.

CliniciansPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled to receive a surgical procedure at Mayo Clinic and their clinicians involved in the care.

You may qualify if:

  • Patients scheduled to receive a surgical spine procedure at Mayo Clinic

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Health System in Mankato

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, 54703, United States

Location

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Links

Study Officials

  • Jon Tilburt, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

May 13, 2020

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations