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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02470728
• Other study ID #: Pro00076402
• Status: Suspended
• Phase: N/A
• Start date: January 2016
• Est. completion date: November 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1200
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain
• Postoperative Pain

Intervention

Other:
• New Clinical Pathway

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Massachusetts Institute of Technology, University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

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