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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
Sponsor:
Information provided by (Responsible Party):
Gil Melmed, Cedars-Sinai Medical Center

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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Pain Opioid Use Crohn Disease Ulcerative Colitis Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Proactive

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.



Primary Outcome Measures :
  1. 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))


Secondary Outcome Measures :
  1. Healthcare Utilization [ Time Frame: From hospital admission until hospital discharge, typically 7 days. ]
    Hospital length of stay (in days)

  2. Functional Activity [ Time Frame: From hospital admission until hospital discharge, typically 7 days. ]
    FitBit activity (number of steps per day)

  3. Opioid-Consumption [ Time Frame: From hospital admission until hospital discharge, typically 7 days. ]
    Milligram morphine-equivalents consumed per day



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Gil Melmed, MD,MS 3104234100 gil.melmed@cshs.org
Contact: Gil Melmed, MD, MS 310-423-4100 gil.melmed@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Gil Y Melmed, MD, MS Cedars-Sinai Medical Center
Study Director: Sameer K Berry, MD, MBA Cedars-Sinai Medical Center

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Responsible Party: Gil Melmed, co-Director, Inflammatory Bowel Disease Center, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03798405     History of Changes
Other Study ID Numbers: Pro00050742
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gil Melmed, Cedars-Sinai Medical Center:
Pain
Inflammatory Bowel Disease
Opioids
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants