An interventional study of Proactive Analgesic Inpatient Narcotic-Sparing in Inflammatory Bowel Diseases, Pain and Opioid Use, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Health services research
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.
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.
1,880 studies on the registry are indexed under Crohn Disease; 461 are open to participants now.
This study's enrollment of 33 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Cedars-Sinai Medical Center is the lead sponsor of 442 studies on the registry; 109 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Exclusion Criteria:
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
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.
Medications suggested to the physician with enhanced ease of ordering.
Also known as: P.A.I.N.-Sparing Bundle
Patient-Reported Pain Scores
Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
Time frame: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
Healthcare Utilization
Hospital length of stay (in days)
Time frame: From hospital admission until hospital discharge, typically 7 days.
Functional Activity
FitBit activity (number of steps per day)
Time frame: From hospital admission until hospital discharge, typically 7 days.
Opioid-Consumption
Milligram morphine-equivalents consumed per day
Time frame: From hospital admission until hospital discharge, typically 7 days.
Plan to share: No
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This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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