Pain Management Intervention Preparatory to a Future Pragmatic Trial

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT04336592

Collaborator

National Institute on Aging (NIA) (NIH)

128

Enrollment

Locations

9.6

Actual Duration (Months)

21.3

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Pharmacological Pain Management	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 Design

Study Type:

Observational

Actual Enrollment :

128 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 13, 2020

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	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.

Arm

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)

Outcome Measures

Primary Outcome Measures

Non-Pharmacological options participation [1 month post-operative]
Number of participants to complete the non-pharmacological options in post-operative Hospital and Rehabilitative Management

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
3	Mayo Clinic Health System in Mankato	Mankato	Minnesota	United States	56001
4	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
5	Mayo Clinic Health System - Eau Claire	Eau Claire	Wisconsin	United States	54703
6	Mayo Clinic Health System - Franciscan Healthcare	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

Mayo Clinic
National Institute on Aging (NIA)

Investigators

Principal Investigator: Jon Tilburt, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Jon C. Tilburt, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04336592

Other Study ID Numbers:

20-001864
UG3AG067593

First Posted:

Apr 7, 2020

Last Update Posted:

Aug 20, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 20, 2021