Reactive vs. Proactive Pain Control in IBD (PAIN-Sparing)
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|ClinicalTrials.gov Identifier: NCT03798405|
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : July 24, 2019
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases Pain Opioid Use Crohn Disease Ulcerative Colitis||Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The primary investigators will be blinded, as will the computer programmers who collect the data.|
|Primary Purpose:||Health Services Research|
|Official Title:||Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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
Medications suggested to the physician with enhanced ease of ordering.
Other Name: P.A.I.N.-Sparing Bundle
No Intervention: 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.
- Patient-Reported Pain Scores [ Time Frame: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days. ]Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
- Healthcare Utilization [ Time Frame: From hospital admission until hospital discharge, typically 7 days. ]Hospital length of stay (in days)
- Functional Activity [ Time Frame: From hospital admission until hospital discharge, typically 7 days. ]FitBit activity (number of steps per day)
- Opioid-Consumption [ Time Frame: From hospital admission until hospital discharge, typically 7 days. ]Milligram morphine-equivalents consumed per day
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798405
|Contact: Gil Melmed, MD,MSfirstname.lastname@example.org|
|Contact: Gil Melmed, MD, MSemail@example.com|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Gil Y Melmed, MD, MS||Cedars-Sinai Medical Center|
|Study Director:||Sameer K Berry, MD, MBA||Cedars-Sinai Medical Center|