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Reactive vs. Proactive Pain Control in IBD (PAIN-Sparing)

Primary Purpose

Inflammatory Bowel Diseases, Pain, Opioid Use

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Analgesic Inpatient Narcotic-Sparing
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inflammatory Bowel Diseases focused on measuring Pain, Inflammatory Bowel Disease, Opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Proactive

Reactive (Control Group)

Arm Description

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".

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.

Outcomes

Primary Outcome Measures

Patient-Reported Pain Scores
Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))

Secondary Outcome Measures

Healthcare Utilization
Hospital length of stay (in days)
Functional Activity
FitBit activity (number of steps per day)
Opioid-Consumption
Milligram morphine-equivalents consumed per day

Full Information

First Posted
December 4, 2018
Last Updated
July 19, 2022
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03798405
Brief Title
Reactive vs. Proactive Pain Control in IBD
Acronym
PAIN-Sparing
Official Title
Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19-related restrictions
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Pain, Opioid Use, Crohn Disease, Ulcerative Colitis
Keywords
Pain, Inflammatory Bowel Disease, Opioids

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The primary investigators will be blinded, as will the computer programmers who collect the data.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proactive
Arm Type
Experimental
Arm Description
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".
Arm Title
Reactive (Control Group)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Proactive Analgesic Inpatient Narcotic-Sparing
Other Intervention Name(s)
P.A.I.N.-Sparing Bundle
Intervention Description
Medications suggested to the physician with enhanced ease of ordering.
Primary Outcome Measure Information:
Title
Patient-Reported Pain Scores
Description
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.
Secondary Outcome Measure Information:
Title
Healthcare Utilization
Description
Hospital length of stay (in days)
Time Frame
From hospital admission until hospital discharge, typically 7 days.
Title
Functional Activity
Description
FitBit activity (number of steps per day)
Time Frame
From hospital admission until hospital discharge, typically 7 days.
Title
Opioid-Consumption
Description
Milligram morphine-equivalents consumed per day
Time Frame
From hospital admission until hospital discharge, typically 7 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Y Melmed, MD, MS
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sameer K Berry, MD, MBA
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reactive vs. Proactive Pain Control in IBD

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