Reactive vs. Proactive Pain Control in IBD

Pain Clinical Trial

— PAIN-Sparing  

Official title:

Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03798405
• Other study ID #: Pro00050742
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Opioid Use
• Pain
• Ulcerative Colitis

Intervention

Behavioral:
• Proactive Analgesic Inpatient Narcotic-Sparing
Medications suggested to the physician with enhanced ease of ordering.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Healthcare Utilization	Hospital length of stay (in days)	From hospital admission until hospital discharge, typically 7 days.
Secondary	Functional Activity	FitBit activity (number of steps per day)	From hospital admission until hospital discharge, typically 7 days.
Secondary	Opioid-Consumption	Milligram morphine-equivalents consumed per day	From hospital admission until hospital discharge, typically 7 days.