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

Cedars-Sinai Medical Center

Status: Terminated

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

Treatments: Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing

Study type: Interventional

Funder types: Other

Identifiers

NCT03798405

Pro00050742

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Proactive

Experimental group

Description:

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".

Treatment:

Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing

Reactive (Control Group)

No Intervention group

Description:

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.