Reactive vs. Proactive Pain Control in IBD

NCT03798405 | Terminated

• 1 other identifier: Pro00050742
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Pain; Opioid Use; Crohn Disease; Ulcerative Colitis

Keywords

Pain; Inflammatory Bowel Disease; Opioids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Healthcare Utilization

  From hospital admission until hospital discharge, typically 7 days.

• Functional Activity

  From hospital admission until hospital discharge, typically 7 days.

• Opioid-Consumption

  From hospital admission until hospital discharge, typically 7 days.

Study Arms (2)

Proactive

EXPERIMENTAL

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

Reactive (Control Group)

NO 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.

Interventions

Proactive Analgesic Inpatient Narcotic-Sparing BEHAVIORAL

Medications suggested to the physician with enhanced ease of ordering.

Also known as: P.A.I.N.-Sparing Bundle

Proactive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Berry SK, Takakura W, Patel D, Govalan R, Ghafari A, Kiefer E, Huang SC, Bresee C, Nuckols TK, Melmed GY. A randomized controlled trial of a proactive analgesic protocol demonstrates reduced opioid use among hospitalized adults with inflammatory bowel disease. Sci Rep. 2023 Dec 16;13(1):22396. doi: 10.1038/s41598-023-48126-0.

  PMID: 38104145 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Pain; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colitis; Colonic Diseases

Study Officials

• Gil Y Melmed, MD, MS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Sameer K Berry, MD, MBA

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary investigators will be blinded, as will the computer programmers who collect the data.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: co-Director, Inflammatory Bowel Disease Center, Principal Investigator

Model Details: Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score \> 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline - all patients will receive a FitBit exercise tracker.

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: January 10, 2019
• Study Start: January 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)