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

Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Opioid Use
• Intervention / Treatment: Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing

Detailed Description

Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with confirmed IBD diagnosis
• Admitted for primary IBD-related sign or symptom

Exclusion Criteria:

• Admitted for primary non-IBD complaint
• Surgery in the last 30 days
• Alternative (non-IBD) GI diagnosis determined
• Age <18
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proactive; 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".	Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing; Medications suggested to the physician with enhanced ease of ordering.; Other Names: P.A.I.N.-Sparing Bundle
No Intervention: Reactive (Control Group); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Pain Scores	Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))	Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization	Hospital length of stay (in days)	From hospital admission until hospital discharge, typically 7 days.
Functional Activity	FitBit activity (number of steps per day)	From hospital admission until hospital discharge, typically 7 days.
Opioid-Consumption	Milligram morphine-equivalents consumed per day	From hospital admission until hospital discharge, typically 7 days.

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Study Director: Sameer K Berry, MD, MBA, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Inflammatory Bowel Disease; Opioids
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Analgesics; Narcotics
• Other Study ID Numbers: Pro00050742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No