Reactive vs. Proactive Pain Control in IBD

NCT ID: NCT03798405

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-07-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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".

Group Type: EXPERIMENTAL

Proactive Analgesic Inpatient Narcotic-Sparing

Intervention Type: BEHAVIORAL

Medications suggested to the physician with enhanced ease of ordering.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Proactive Analgesic Inpatient Narcotic-Sparing

Medications suggested to the physician with enhanced ease of ordering.

Intervention Type: BEHAVIORAL

Other Intervention Names

P.A.I.N.-Sparing Bundle

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gil Melmed

co-Director, Inflammatory Bowel Disease Center, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gil Y Melmed, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Sameer K Berry, MD, MBA

Role: STUDY_DIRECTOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38104145 (View on PubMed)

Other Identifiers

Pro00050742

Identifier Type: -

Identifier Source: org_study_id