Pain Management Intervention Preparatory to a Future Pragmatic Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Pharmacological Pain Management
• Intervention / Treatment: Behavioral: Non-pharmacological Options in post-operative Hospital and Rehabilitative Management (NOHARM)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Mayo Clinic Health System in Mankato
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54703
      • Mayo Clinic Health System - Eau Claire
    • La Crosse, Wisconsin, United States, 54601
      • Mayo Clinic Health System - Franciscan Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients scheduled to receive a surgical spine procedure at Mayo Clinic	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.
Clinicians; Surgeons, Physician pain specialists and allied health caring for participating patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Pharmacological options participation	Number of participants to complete the non-pharmacological options in post-operative Hospital and Rehabilitative Management	1 month post-operative

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jon Tilburt, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20-001864; UG3AG067593 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No