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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Acute Pain, Postoperative Pain

Intervention / Treatment
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* Other: New Clinical Pathway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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