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

NCT02470728 | Terminated DMC

• 1 other identifier: Pro00076402
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Returns to Acute Care

  Hospital Readmissions and Emergency Department Utilizations

  Discharge through 90 days post-discharge

Secondary Outcomes (9)

• Opioid Analgesic Use

  Discharge through 90 days post-discharge

• Opioid Analgesic Use

  Admission through 12 months post-discharge

• Opioid Tolerance Status

  Admission through 12 months post-discharge

• Pain at Discharge

  Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization

• Hospital Length of Stay

  Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization

Study Arms (2)

Control Group

NO INTERVENTION

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.

Treatment Group

EXPERIMENTAL

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

Interventions

New Clinical Pathway OTHER

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Massachusetts Institute of Technology: collaborator
• University of California, Irvine: collaborator

Study Sites (2)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (19)

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  PMID: 25151343 BACKGROUND

MeSH Terms

Conditions

Pain; Acute Pain; Pain, Postoperative; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Disease Attributes

Study Officials

• Padma Gulur, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: June 12, 2015
• Study Start: January 1, 2016
• Primary Completion: July 29, 2019
• Study Completion: July 31, 2019
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (2)