Clinical trial NCT02470728: Optimal Management of Pain in Hospitalized Patients - Opioid Tolerant Populations.
Official title: Pain Management Options for Opioid Tolerant Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Acute Pain
Postoperative Pain
Keywords: 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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
name: University of California, Irvine
First posted: 2015-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Returns to Acute Care
timeFrame: Discharge through 90 days post-discharge
Secondary outcomes:
measure: Opioid Analgesic Use
timeFrame: Discharge through 90 days post-discharge
measure: Opioid Analgesic Use
timeFrame: Admission through 12 months post-discharge
measure: Opioid Tolerance Status
timeFrame: Admission through 12 months post-discharge
measure: Pain at Discharge
timeFrame: Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization
measure: Hospital Length of Stay
timeFrame: Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization
measure: Latency to Hospital Readmission
timeFrame: Discharge through 12 months post-discharge
measure: Returns to Acute Care
timeFrame: Discharge through 12 months post-discharge
measure: Healthcare Expenditures
timeFrame: Admission through 12 months post-discharge
measure: Use of Rescue Drugs
timeFrame: Admission through 12 months post-discharge
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Padma Gulur, MD
role: PRINCIPAL_INVESTIGATOR
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