Clinical trial NCT03798405: Reactive vs. Proactive Pain Control in IBD
Official title: Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Pain
Opioid Use
Crohn Disease
Ulcerative Colitis
Keywords: Pain
Inflammatory Bowel Disease
Opioids
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Patient-Reported Pain Scores
timeFrame: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
Secondary outcomes:
measure: Healthcare Utilization
timeFrame: From hospital admission until hospital discharge, typically 7 days.
measure: Functional Activity
timeFrame: From hospital admission until hospital discharge, typically 7 days.
measure: Opioid-Consumption
timeFrame: From hospital admission until hospital discharge, typically 7 days.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Gil Y Melmed, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Sameer K Berry, MD, MBA
role: STUDY_DIRECTOR
References: