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Optimal Management of Pain in Hospitalized Patients - Opioid Tolerant Populations.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470728
Recruitment Status : Suspended (Pending funding)
First Posted : June 12, 2015
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Massachusetts Institute of Technology
University of California, Irvine
Information provided by (Responsible Party):
Duke University

Brief Summary:
Pain is a symptom that drives hospital admissions, and pain management is required by most patients during their hospital stay. Further, the use of medications such as opioids can lead to upward-spiraling doses, especially among chronic pain patients whose resource utilization rates are high. Many initiatives aim to reduce the costs of these "high-resource utilizing" patients. One exciting aspect of improving the management of pain is that this may help prevent patients from ever becoming high-cost in the first place. The purpose of this study is to examine the impacts of an early and sustained intervention pathway, in comparison to the current standard of care, for the treatment of pain in opioid tolerant patients. It is hypothesized that patients randomized to the intervention pathway, in comparison to the control, will lead to decreased costs of care, a reduction in opioid usage within 3 and 6 months, and decrease in hospital readmission rates.

Condition or disease Intervention/treatment Phase
Pain Acute Pain Postoperative Pain Other: New Clinical Pathway Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pain Management Options for Opioid Tolerant Patients: a Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Those randomized into the control group will receive the current standard of care for pain management. This standard care pathway involves a pain management specialist consultation only at the request of the primary admitting team. The pain management consultation can occur at any time during the patient's inpatient stay and care by these specialists ends at discharge.
Experimental: Treatment Group
Subjects randomized into the treatment (early intervention) group will receive the New Clinical Pathway: pain management care coordinated by pain-management specialists from inpatient admission through 60 days after discharge.
Other: New Clinical Pathway



Primary Outcome Measures :
  1. Returns to Acute Care [ Time Frame: Discharge through 90 days post-discharge ]
    Hospital Readmissions and Emergency Department Utilizations


Secondary Outcome Measures :
  1. Opioid Analgesic Use [ Time Frame: Discharge through 90 days post-discharge ]
    Quantification of opioid analgesic use over time

  2. Opioid Analgesic Use [ Time Frame: Admission through 12 months post-discharge ]
    Quantification of opioid analgesic use over time

  3. Opioid Tolerance Status [ Time Frame: Admission through 12 months post-discharge ]
    Opioid tolerance as inferred from opioid prescription and usage per FDA exposure threshold definition for opioid tolerance.

  4. Pain at Discharge [ Time Frame: Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization ]
    Patient-reported pain at the time of discharge from index hospitalization

  5. Hospital Length of Stay [ Time Frame: Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization ]
    Duration of index inpatient hospitalization.

  6. Latency to Hospital Readmission [ Time Frame: Discharge through 12 months post-discharge ]
    Time between discharge from index hospitalization to readmission

  7. Returns to Acute Care [ Time Frame: Discharge through 12 months post-discharge ]
    Hospital Readmissions and Emergency Department Utilizations at an extended time horizon

  8. Healthcare Expenditures [ Time Frame: Admission through 12 months post-discharge ]
    Inpatient and outpatients costs

  9. Use of Rescue Drugs [ Time Frame: Admission through 12 months post-discharge ]
    Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)



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:

  • Adult patients (18 years and older)
  • Known opioid tolerant (as determined per FDA criteria)
  • Agree to sign the informed consent and HIPAA forms

Exclusion Criteria:

  • Patients under the age of 18 years
  • No known opioid tolerance
  • Do not agree to sign the informed consent and HIPAA forms

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): NCT02470728


Locations
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United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Massachusetts Institute of Technology
University of California, Irvine
Investigators
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Principal Investigator: Padma Gulur, MD Duke University

Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02470728    
Other Study ID Numbers: Pro00076402
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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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 Duke University:
patient readmission
pain relief units
pain centers
multidisciplinary pain clinics
multidisciplinary pain centers
pain clinics
hospital readmission
emergencies
emergency medicine
critical care
emergency treatment
opioid
acute pain service
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents