Study Summary
This trial will test if a NOHARM Conversation Guide, with embedded clinical decision support, can help improve pain and function 3 months after surgery.
Treatment Effectiveness
Effectiveness Progress
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Study Objectives
5 Primary · 0 Secondary · Reporting Duration: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
3 Months Post-Surgery
Use of Non-Pharmacological Pain Control Modalities
3-Months Post-Surgery
Opioid Use
Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
PROMIS-CAT Pain
PROMIS-CAT Physical Function
Baseline (before hospital discharge), 3-Months Post-Surgery
PROMIS-CAT Physical Anxiety
Trial Safety
Safety Progress
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Trial Design
2 Treatment Groups
Control Arm
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
117510 Total Participants · 2 Treatment Groups
Primary Treatment: Conversation Guide + Clinical Support · No Placebo Group · N/A
Intervention
Behavioral
Experimental Group · 1 Intervention: Conversation Guide + Clinical Support · Intervention Types: BehavioralControl ArmNoIntervention Group · 1 Intervention: Control Arm · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (before hospital discharge), 1-,2-, and 3-months post-surgery
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,411 Previous Clinical Trials
3,366,636 Total Patients Enrolled
Mayo ClinicLead Sponsor
2,917 Previous Clinical Trials
3,389,641 Total Patients Enrolled
Andrea L ChevillePrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
15,000 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Any patients over the age of 18.
The individual must be having surgery at one of the approved locations.
People who are 18 years old or younger.
References
- Redmond, Sarah, Jon Tilburt, Andrea Cheville, and Mayo Clinic NOHARM Research Team. 2022. “Non-pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-wedge Cluster-randomized Pragmatic Clinical Trial”. Pain and Therapy. Springer Science and Business Media LLC. doi:10.1007/s40122-022-00393-x.
- Redmond, Sarah, Jon Tilburt, Andrea Cheville, and Mayo Clinic NOHARM Research Team. 2022. “Non-pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-wedge Cluster-randomized Pragmatic Clinical Trial”. Pain and Therapy. Springer Science and Business Media LLC. doi:10.1007/s40122-022-00393-x.
- Redmond S; Mayo Clinic NOHARM Research Team; Tilburt J, Cheville A. Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial. Pain Ther. 2022 Sep;11(3):1037-1053. doi: 10.1007/s40122-022-00393-x. Epub 2022 Jun 3.
- Andrea Cheville 2021. "Non-pharmacological Pain Management After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570371.
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Conditions
Cancer Related
Treatments