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

Sponsor

Duke University (Other)

Overall Status

Suspended

CT.gov ID

NCT02470728

Collaborator

Massachusetts Institute of Technology (Other), University of California, Irvine (Other)

1,200

Enrollment

Locations

Arms

118

Duration (Months)

600

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Acute Pain Postoperative Pain	Other: New Clinical Pathway	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

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 :

Jan 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Returns to Acute Care [Discharge through 90 days post-discharge]
Hospital Readmissions and Emergency Department Utilizations

Secondary Outcome Measures

Opioid Analgesic Use [Discharge through 90 days post-discharge]
Quantification of opioid analgesic use over time
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
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
Healthcare Expenditures [Admission through 12 months post-discharge]
Inpatient and outpatients costs
Use of Rescue Drugs [Admission through 12 months post-discharge]
Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine Medical Center	Orange	California	United States	92868
2	Duke University Medical Center	Durham	North Carolina	United States	27710