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Behavioral Intervention

Reactive vs. Proactive Pain Control in IBD (PAIN-Sparing Trial)

N/A
Waitlist Available
Led By Gil Y Melmed, MD, MS
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from hospital admission until hospital discharge, typically 7 days.
Awards & highlights
No Placebo-Only Group

Summary

The investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution's Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive" analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe. Aims: Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors. Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors. Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.

Eligible Conditions
  • Crohn's Disease
  • Inflammatory Bowel Disease
  • Colitis
  • Pain
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from hospital admission until hospital discharge, typically 7 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from hospital admission until hospital discharge, typically 7 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient-Reported Pain Scores
Secondary study objectives
Functional Activity
Healthcare Utilization
Opioid-Consumption

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ProactiveExperimental Treatment1 Intervention
Proactive Analgesic Inpatient Narcotic-Sparing: Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol".
Group II: Reactive (Control Group)Active Control1 Intervention
Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,331 Total Patients Enrolled
Gil Y Melmed, MD, MSPrincipal InvestigatorCedars-Sinai Medical Center
Sameer K Berry, MD, MBAStudy DirectorCedars-Sinai Medical Center
~5 spots leftby Dec 2025