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NCT04570371 Clinical Trial

Non-pharmacological Pain Management After Surgery

Surgical Procedure, Unspecified Clinical Trial

— NOHARM  

Official title:
Non-Pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management: The NOHARM Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04570371
Other study ID # 20-004839
Secondary ID UG3AG067593
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date July 2024

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 86726
Est. completion date July 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota

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 PROMIS-CAT Pain Change in patient reported pain; measured on scale of 1-100 Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Primary PROMIS-CAT Physical Function Change in patient reported Physical Function; measured on scale of 1-100 Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Primary PROMIS-CAT Physical Anxiety Change in patient reported Anxiety; measured on scale of 1-100 Baseline (before hospital discharge), 3-Months Post-Surgery
Primary Use of Non-Pharmacological Pain Control Modalities Number of participants using Non-Pharmacological Pain Control Modalities 3 Months Post-Surgery
Primary Opioid Use Total amount of opioid pain medication used after surgery 3-Months Post-Surgery
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