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

Not Applicable

Terminated

• Conditions: Postoperative Pain; Pain; Acute Pain
• Interventions: Other: New Clinical Pathway

• Registration Number: NCT02470728
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Study Start: 2016-01
• Primary Completion: 2019-07-29
• Study Completion: 2019-07-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	New Clinical Pathway	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.

Primary Outcome Measures

Name	Time	Method
Returns to Acute Care	Discharge through 90 days post-discharge	Hospital Readmissions and Emergency Department Utilizations

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization	Duration of index inpatient hospitalization.
Latency to Hospital Readmission	Discharge through 12 months post-discharge	Time between discharge from index hospitalization to readmission
Returns to Acute Care	Discharge through 12 months post-discharge	Hospital Readmissions and Emergency Department Utilizations at an extended time horizon
Use of Rescue Drugs	Admission through 12 months post-discharge	Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)
Opioid Analgesic Use	Admission through 12 months post-discharge	Quantification of opioid analgesic use over time
Opioid Tolerance Status	Admission through 12 months post-discharge	Opioid tolerance as inferred from opioid prescription and usage per FDA exposure threshold definition for opioid tolerance.
Pain at Discharge	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
Healthcare Expenditures	Admission through 12 months post-discharge	Inpatient and outpatients costs

Trial Locations

Locations (2)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States