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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02470728
Enrollment
60
Registered
2015-06-12
Start date
2016-01-31
Completion date
2019-07-31
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, 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

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.

Interventions

OTHERNew Clinical Pathway

Sponsors

Massachusetts Institute of Technology
CollaboratorOTHER
University of California, Irvine
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Returns to Acute CareDischarge through 90 days post-dischargeHospital Readmissions and Emergency Department Utilizations

Secondary

MeasureTime frameDescription
Opioid Tolerance StatusAdmission through 12 months post-dischargeOpioid tolerance as inferred from opioid prescription and usage per FDA exposure threshold definition for opioid tolerance.
Pain at DischargeMeasured upon day of discharge from index hospitalization; up to 18 months from the date of randomizationPatient-reported pain at the time of discharge from index hospitalization
Hospital Length of StayMeasured upon day of discharge from index hospitalization; up to 18 months from the date of randomizationDuration of index inpatient hospitalization.
Opioid Analgesic UseDischarge through 90 days post-dischargeQuantification of opioid analgesic use over time
Returns to Acute CareDischarge through 12 months post-dischargeHospital Readmissions and Emergency Department Utilizations at an extended time horizon
Healthcare ExpendituresAdmission through 12 months post-dischargeInpatient and outpatients costs
Use of Rescue DrugsAdmission through 12 months post-dischargeAntagonist usages for the reversal of index drug effects (opioid and benzodiazepine)
Latency to Hospital ReadmissionDischarge through 12 months post-dischargeTime between discharge from index hospitalization to readmission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026