search
Back to results

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

Primary Purpose

Pain, Acute Pain, Postoperative Pain

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New Clinical Pathway
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California, Irvine Medical Center
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Returns to Acute Care
Hospital Readmissions and Emergency Department Utilizations

Secondary Outcome Measures

Opioid Analgesic Use
Quantification of opioid analgesic use over time
Opioid Analgesic Use
Quantification of opioid analgesic use over time
Opioid Tolerance Status
Opioid tolerance as inferred from opioid prescription and usage per FDA exposure threshold definition for opioid tolerance.
Pain at Discharge
Patient-reported pain at the time of discharge from index hospitalization
Hospital Length of Stay
Duration of index inpatient hospitalization.
Latency to Hospital Readmission
Time between discharge from index hospitalization to readmission
Returns to Acute Care
Hospital Readmissions and Emergency Department Utilizations at an extended time horizon
Healthcare Expenditures
Inpatient and outpatients costs
Use of Rescue Drugs
Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)

Full Information

First Posted
January 13, 2015
Last Updated
December 1, 2022
Sponsor
Duke University
Collaborators
Massachusetts Institute of Technology, University of California, Irvine
search

1. Study Identification

Unique Protocol Identification Number
NCT02470728
Brief Title
Optimal Management of Pain in Hospitalized Patients - Opioid Tolerant Populations.
Official Title
Pain Management Options for Opioid Tolerant Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Pending funding
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Massachusetts Institute of Technology, University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute 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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
New Clinical Pathway
Primary Outcome Measure Information:
Title
Returns to Acute Care
Description
Hospital Readmissions and Emergency Department Utilizations
Time Frame
Discharge through 90 days post-discharge
Secondary Outcome Measure Information:
Title
Opioid Analgesic Use
Description
Quantification of opioid analgesic use over time
Time Frame
Discharge through 90 days post-discharge
Title
Opioid Analgesic Use
Description
Quantification of opioid analgesic use over time
Time Frame
Admission through 12 months post-discharge
Title
Opioid Tolerance Status
Description
Opioid tolerance as inferred from opioid prescription and usage per FDA exposure threshold definition for opioid tolerance.
Time Frame
Admission through 12 months post-discharge
Title
Pain at Discharge
Description
Patient-reported pain at the time of discharge from index hospitalization
Time Frame
Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization
Title
Hospital Length of Stay
Description
Duration of index inpatient hospitalization.
Time Frame
Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization
Title
Latency to Hospital Readmission
Description
Time between discharge from index hospitalization to readmission
Time Frame
Discharge through 12 months post-discharge
Title
Returns to Acute Care
Description
Hospital Readmissions and Emergency Department Utilizations at an extended time horizon
Time Frame
Discharge through 12 months post-discharge
Title
Healthcare Expenditures
Description
Inpatient and outpatients costs
Time Frame
Admission through 12 months post-discharge
Title
Use of Rescue Drugs
Description
Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)
Time Frame
Admission through 12 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Padma Gulur, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24084922
Citation
Raebel MA, Newcomer SR, Reifler LM, Boudreau D, Elliott TE, DeBar L, Ahmed A, Pawloski PA, Fisher D, Donahoo WT, Bayliss EA. Chronic use of opioid medications before and after bariatric surgery. JAMA. 2013 Oct 2;310(13):1369-76. doi: 10.1001/jama.2013.278344.
Results Reference
background
PubMed Identifier
25203874
Citation
Brown EG, Burgess D, Li CS, Canter RJ, Bold RJ. Hospital readmissions: necessary evil or preventable target for quality improvement. Ann Surg. 2014 Oct;260(4):583-9; discussion 589-91. doi: 10.1097/SLA.0000000000000923.
Results Reference
background
PubMed Identifier
25054400
Citation
Gulur P, Williams L, Chaudhary S, Koury K, Jaff M. Opioid tolerance--a predictor of increased length of stay and higher readmission rates. Pain Physician. 2014 Jul-Aug;17(4):E503-7.
Results Reference
background
PubMed Identifier
23553809
Citation
Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013 Apr;33(4):383-91. doi: 10.1002/phar.1223.
Results Reference
background
PubMed Identifier
23930467
Citation
Lembke A. Why doctors prescribe opioids to known opioid abusers. How cultural attitudes and financial disincentives affect the prescribing habits of physicians. Minn Med. 2013 Mar;96(3):36-7. No abstract available.
Results Reference
background
PubMed Identifier
24758595
Citation
Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies--tackling the opioid-overdose epidemic. N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Epub 2014 Apr 23. No abstract available.
Results Reference
background
PubMed Identifier
24525993
Citation
Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S. Causes and risk factors for 30-day unplanned readmissions after lumbar spine surgery. Spine (Phila Pa 1976). 2014 Apr 20;39(9):761-8. doi: 10.1097/BRS.0000000000000270.
Results Reference
background
PubMed Identifier
23820989
Citation
Hazratjee N, Agito M, Lopez R, Lashner B, Rizk MK. Hospital readmissions in patients with inflammatory bowel disease. Am J Gastroenterol. 2013 Jul;108(7):1024-32. doi: 10.1038/ajg.2012.343.
Results Reference
background
PubMed Identifier
22237030
Citation
Centers for Disease Control and Prevention (CDC). CDC grand rounds: prescription drug overdoses - a U.S. epidemic. MMWR Morb Mortal Wkly Rep. 2012 Jan 13;61(1):10-3.
Results Reference
background
PubMed Identifier
9236756
Citation
Bell JR. Australian trends in opioid prescribing for chronic non-cancer pain, 1986-1996. Med J Aust. 1997 Jul 7;167(1):26-9. doi: 10.5694/j.1326-5377.1997.tb138759.x.
Results Reference
background
PubMed Identifier
24777731
Citation
Bot AG, Bekkers S, Arnstein PM, Smith RM, Ring D. Opioid use after fracture surgery correlates with pain intensity and satisfaction with pain relief. Clin Orthop Relat Res. 2014 Aug;472(8):2542-9. doi: 10.1007/s11999-014-3660-4. Epub 2014 Apr 29.
Results Reference
background
PubMed Identifier
24227700
Citation
Herzig SJ, Rothberg MB, Cheung M, Ngo LH, Marcantonio ER. Opioid utilization and opioid-related adverse events in nonsurgical patients in US hospitals. J Hosp Med. 2014 Feb;9(2):73-81. doi: 10.1002/jhm.2102. Epub 2013 Nov 13.
Results Reference
background
PubMed Identifier
12873949
Citation
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
Results Reference
background
PubMed Identifier
19726210
Citation
Torrance N, Elliott AM, Lee AJ, Smith BH. Severe chronic pain is associated with increased 10 year mortality. A cohort record linkage study. Eur J Pain. 2010 Apr;14(4):380-6. doi: 10.1016/j.ejpain.2009.07.006. Epub 2009 Sep 1.
Results Reference
background
PubMed Identifier
24802165
Citation
Pavon JM, Zhao Y, McConnell E, Hastings SN. Identifying risk of readmission in hospitalized elderly adults through inpatient medication exposure. J Am Geriatr Soc. 2014 Jun;62(6):1116-21. doi: 10.1111/jgs.12829. Epub 2014 May 6.
Results Reference
background
PubMed Identifier
24854317
Citation
Muthuvel G, Tevis SE, Liepert AE, Agarwal SK, Kennedy GD. A composite index for predicting readmission following emergency general surgery. J Trauma Acute Care Surg. 2014 Jun;76(6):1467-72. doi: 10.1097/TA.0000000000000223.
Results Reference
background
PubMed Identifier
25064214
Citation
Wilson GC, Cutler Quillin R 3rd, Sutton JM, Wima K, Shaw JJ, Hoehn RS, Paquette IM, Abbott DE, Shah SA. Factors related to readmission after major elective surgery. Dig Dis Sci. 2015 Jan;60(1):47-53. doi: 10.1007/s10620-014-3306-0. Epub 2014 Jul 27.
Results Reference
background
PubMed Identifier
25147171
Citation
Anderegg SV, Wilkinson ST, Couldry RJ, Grauer DW, Howser E. Effects of a hospitalwide pharmacy practice model change on readmission and return to emergency department rates. Am J Health Syst Pharm. 2014 Sep 1;71(17):1469-79. doi: 10.2146/ajhp130686.
Results Reference
background
PubMed Identifier
25151343
Citation
Tayne S, Merrill CA, Shah SN, Kim J, Mackey WC. Risk factors for 30-day readmissions and modifying postoperative care after gastric bypass surgery. J Am Coll Surg. 2014 Sep;219(3):489-95. doi: 10.1016/j.jamcollsurg.2014.03.054. Epub 2014 May 20.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs