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AzTrials

PainNCT02470728

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

A study testing New Clinical Pathway in people with Pain and Acute Pain, run by Duke University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Acute Pain, Postoperative Pain
What is being tested?
New Clinical Pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
Jan 2016to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients (18 years and older)
  • Known opioid tolerant (as determined per FDA criteria)
  • Agree to sign the informed consent and HIPAA forms

Who cannot join

  • Patients under the age of 18 years
  • No known opioid tolerance
  • Do not agree to sign the informed consent and HIPAA forms

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of California, Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

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

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.

Being tested
New Clinical Pathway
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
Medical subject headings
Pain, Acute Pain, Pain, Postoperative, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New Clinical PathwayOther

Study groups in NCT02470728
Study groupRoleWhat they receive
Control GroupNo interventionThose 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.
Treatment GroupExperimentalSubjects 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.
Receives: Other: New Clinical Pathway

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Returns to Acute Care

    Hospital Readmissions and Emergency Department Utilizations

    Measured: Discharge through 90 days post-discharge

Secondary outcomes (9)

  1. Opioid Analgesic Use

    Quantification of opioid analgesic use over time

    Measured: Discharge through 90 days post-discharge

  2. Opioid Analgesic Use

    Quantification of opioid analgesic use over time

    Measured: Admission through 12 months post-discharge

  3. Opioid Tolerance Status

    Opioid tolerance as inferred from opioid prescription and usage per FDA exposure threshold definition for opioid tolerance.

    Measured: Admission through 12 months post-discharge

  4. Pain at Discharge

    Patient-reported pain at the time of discharge from index hospitalization

    Measured: Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization

  5. Hospital Length of Stay

    Duration of index inpatient hospitalization.

    Measured: Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization

  6. Latency to Hospital Readmission

    Time between discharge from index hospitalization to readmission

    Measured: Discharge through 12 months post-discharge

  7. Returns to Acute Care

    Hospital Readmissions and Emergency Department Utilizations at an extended time horizon

    Measured: Discharge through 12 months post-discharge

  8. Healthcare Expenditures

    Inpatient and outpatients costs

    Measured: Admission through 12 months post-discharge

  9. Use of Rescue Drugs

    Antagonist usages for the reversal of index drug effects (opioid and benzodiazepine)

    Measured: Admission through 12 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion29 Jul 2019
  4. Study completion31 Jul 2019

Why it stopped: Budgetary issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02470728
Sponsor's protocol ID
Pro00076402
Status last verified
Feb 2025
First submitted
13 Jan 2015
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24084922

  • 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.

    PubMed 25203874

  • 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.

    PubMed 25054400

  • 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.

    PubMed 23553809

  • 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.

    PubMed 23930467

  • 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.

    PubMed 24758595

  • 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.

    PubMed 24525993

  • 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.

    PubMed 23820989

  • 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.

    PubMed 22237030

  • 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.

    PubMed 9236756

  • 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.

    PubMed 24777731

  • 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.

    PubMed 24227700

  • 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.

    PubMed 12873949

  • 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.

    PubMed 19726210

  • 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.

    PubMed 24802165

Questions about this trial

What is this clinical trial studying?

A study testing New Clinical Pathway in people with Pain and Acute Pain, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Budgetary issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Returns to Acute Care (time frame: Discharge through 90 days post-discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02470728, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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