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Non-pharmacological Pain Management After Surgery (NOHARM)

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ClinicalTrials.gov Identifier: NCT04570371
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Andrea Cheville, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Behavioral: Conversation Guide + Clinical Support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a stepped wedge cluster randomized pragmatic clinical trial.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Non-Pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management: The NOHARM Trial
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

No Intervention: 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).



Primary Outcome Measures :
  1. PROMIS-CAT Pain [ Time Frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery ]
    Change in patient reported pain; measured on scale of 1-100

  2. PROMIS-CAT Physical Function [ Time Frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery ]
    Change in patient reported Physical Function; measured on scale of 1-100

  3. PROMIS-CAT Physical Anxiety [ Time Frame: Baseline (before hospital discharge), 3-Months Post-Surgery ]
    Change in patient reported Anxiety; measured on scale of 1-100

  4. Use of Non-Pharmacological Pain Control Modalities [ Time Frame: 3 Months Post-Surgery ]
    Number of participants using Non-Pharmacological Pain Control Modalities

  5. Opioid Use [ Time Frame: 3-Months Post-Surgery ]
    Total amount of opioid pain medication used after surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570371


Locations
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United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Cindy Tofthagen, PhD    904-953-1409    tofthagen.cindy@mayo.edu   
Contact: Amanda Nelson    507-538-4950    nelson.amanda2@mayo.edu   
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amanda Nelson    507-538-4950    nelson.amanda2@mayo.edu   
Contact: Natalie Wegner       wegner.natalie@mayo.edu   
Principal Investigator: Andrea Cheville, MD         
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Andrea L Cheville Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Andrea Cheville, Mayo Clinic:
Study Protocol  [PDF] May 25, 2021

Additional Information:
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Responsible Party: Andrea Cheville, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04570371    
Other Study ID Numbers: 20-004839
UG3AG067593 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No