Non-pharmacological Pain Management After Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Behavioral: Conversation Guide + Clinical Support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a stepped wedge cluster randomized pragmatic clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control Arm<br>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). | |

What is the study measuring?
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Primary Outcome Measures

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