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

• ClinicalTrials.gov Identifier: NCT03798405
• Recruitment Status: Recruiting
• First Posted: January 10, 2019
• Last Update Posted: July 24, 2019
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Gil Melmed, Cedars-Sinai Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Diseases; Pain; Opioid Use; Crohn Disease; Ulcerative Colitis	Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The primary investigators will be blinded, as will the computer programmers who collect the data.
• Primary Purpose: Health Services Research
• Official Title: Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
• Actual Study Start Date: January 1, 2019
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Gil Melmed, MD,MS; 3104234100; gil.melmed@cshs.org

Contact: Gil Melmed, MD, MS; 310-423-4100; gil.melmed@cshs.org

Locations

United States, California

Cedars-Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Gil Y Melmed, MD, MS; Cedars-Sinai Medical Center
• Study Director: Sameer K Berry, MD, MBA; Cedars-Sinai Medical Center

More Information

• Responsible Party: Gil Melmed, co-Director, Inflammatory Bowel Disease Center, Principal Investigator, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT03798405 History of Changes
• Other Study ID Numbers: Pro00050742
• First Posted: January 10, 2019
• Last Update Posted: July 24, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gil Melmed, Cedars-Sinai Medical Center:

Pain; Inflammatory Bowel Disease; Opioids

Additional relevant MeSH terms:

Crohn Disease; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Colonic Diseases; Narcotics; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Central Nervous System Depressants