Optimal Management of Pain in Hospitalized Patients - Opioid Tolerant Populations.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02470728|
Recruitment Status : Suspended (Pending funding)
First Posted : June 12, 2015
Last Update Posted : November 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain Acute Pain Postoperative Pain||Other: New Clinical Pathway||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pain Management Options for Opioid Tolerant Patients: a Randomized Controlled Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2025|
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
- Returns to Acute Care [ Time Frame: Discharge through 90 days post-discharge ]Hospital Readmissions and Emergency Department Utilizations
- Opioid Analgesic Use [ Time Frame: Discharge through 90 days post-discharge ]Quantification of opioid analgesic use over time
- Opioid Analgesic Use [ Time Frame: Admission through 12 months post-discharge ]Quantification of opioid analgesic use over time
- 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.
- 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
- 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.
- Latency to Hospital Readmission [ Time Frame: Discharge through 12 months post-discharge ]Time between discharge from index hospitalization to readmission
- Returns to Acute Care [ Time Frame: Discharge through 12 months post-discharge ]Hospital Readmissions and Emergency Department Utilizations at an extended time horizon
- Healthcare Expenditures [ Time Frame: Admission through 12 months post-discharge ]Inpatient and outpatients costs
- Use of Rescue Drugs [ Time Frame: Admission through 12 months post-discharge ]Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470728
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Padma Gulur, MD||Duke University|