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

January 16, 2024 updated by: Duke University

Pain Management Options for Opioid Tolerant Patients: a Randomized Controlled Trial

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Returns to Acute Care
Time Frame: Discharge through 90 days post-discharge
Hospital Readmissions and Emergency Department Utilizations
Discharge through 90 days post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Analgesic Use
Time Frame: Discharge through 90 days post-discharge
Quantification of opioid analgesic use over time
Discharge through 90 days post-discharge
Opioid Analgesic Use
Time Frame: Admission through 12 months post-discharge
Quantification of opioid analgesic use over time
Admission through 12 months post-discharge
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.
Admission through 12 months post-discharge
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
Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization
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.
Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization
Latency to Hospital Readmission
Time Frame: Discharge through 12 months post-discharge
Time between discharge from index hospitalization to readmission
Discharge through 12 months post-discharge
Returns to Acute Care
Time Frame: Discharge through 12 months post-discharge
Hospital Readmissions and Emergency Department Utilizations at an extended time horizon
Discharge through 12 months post-discharge
Healthcare Expenditures
Time Frame: Admission through 12 months post-discharge
Inpatient and outpatients costs
Admission through 12 months post-discharge
Use of Rescue Drugs
Time Frame: Admission through 12 months post-discharge
Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)
Admission through 12 months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Massachusetts Institute of Technology
University of California, Irvine

Investigators

  • Principal Investigator: Padma Gulur, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimated)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00076402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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