Pain Management Intervention Preparatory to a Future Pragmatic Trial

Non-Pharmacological Pain Management Clinical Trial

Official title:

Pilot Testing a Pain Management Intervention Preparatory to a Future Pragmatic Trial (NOHARM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336592
• Other study ID #: 20-001864
• Secondary ID: UG3AG067593
• Status: Completed
• Start date: May 13, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a pilot study to test promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure. This pilot study will confirm the feasibility of patient-facing as well as clinician-facing decision support components of an electronic health record (EHR) imbedded evidence-based bundle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Surgeons, Physician pain specialists and allied health caring for patients meeting patient inclusion criteria

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Non-Pharmacological Pain Management

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Health System - Eau Claire	Eau Claire	Wisconsin
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic Health System - Franciscan Healthcare	La Crosse	Wisconsin
United States	Mayo Clinic Health System in Mankato	Mankato	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Pharmacological options participation	Number of participants to complete the non-pharmacological options in post-operative Hospital and Rehabilitative Management	1 month post-operative

External Links

•   Mayo Clinic Clinical Trials