Reactive vs. Proactive Pain Control in IBD (PAIN-Sparing)
Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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California
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Los Angeles, California, Förenta staterna, 90048
- Cedars-Sinai Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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". |
Medications suggested to the physician with enhanced ease of ordering.
Andra namn:
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Inget ingripande: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patient-Reported Pain Scores
Tidsram: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
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Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
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Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Healthcare Utilization
Tidsram: From hospital admission until hospital discharge, typically 7 days.
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Hospital length of stay (in days)
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From hospital admission until hospital discharge, typically 7 days.
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Functional Activity
Tidsram: From hospital admission until hospital discharge, typically 7 days.
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FitBit activity (number of steps per day)
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From hospital admission until hospital discharge, typically 7 days.
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Opioid-Consumption
Tidsram: From hospital admission until hospital discharge, typically 7 days.
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Milligram morphine-equivalents consumed per day
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From hospital admission until hospital discharge, typically 7 days.
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Sameer K Berry, MD, MBA, Cedars-Sinai Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00050742
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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