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FDA: Lowering Orthopedic Opioid Dosing (FLOOD) (FLOOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576392
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
This randomized trial evaluates an intervention to minimize use of opioids following total hip and total knee replacement. Half the participants will receive an intervention (mailed educational materials, followed by a pharmacist call), and half will receive usual care.

Condition or disease Intervention/treatment Phase
Post-operative Pain Behavioral: Intervention Not Applicable

Detailed Description:
Surgeons and anesthesiologists prescribe opioids and other analgesic medications for acute, post-surgical pain. Recent studies have reported that some patients persist in taking opioids for months beyond the surgery. While opioids are commonly used for pain management following surgery, patients and their providers often don't have a planned method to optimize opioid exposure. This can lead to patients entering a cycle of opioid use that is difficult to manage, because, as opioid exposure is continued, pain relief is reduced and side effects increase. The investigators' study is aimed at reducing opioid exposure following total hip and total knee replacement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Reducing the Use of Opioid Therapy Following Orthopedic Surgery: A Randomized Controlled Trial
Study Start Date : July 1, 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Floods

Arm Intervention/treatment
Experimental: Intervention
Informational letter mailed approximately 2 weeks prior to surgery, informational letter mailed approximately 2 weeks post surgery, pharmacist call if refill opioid medicine more than 28 days after surgery
Behavioral: Intervention
Intervention consisted of a mailing 2 weeks prior to surgery, another 2 weeks post surgery, and a pharmacist intervention if a refill of opioid medication was requested within 90 days of surgery.

No Intervention: Control
Usual Care



Primary Outcome Measures :
  1. Average morphine equivalents [ Time Frame: 90 days ]
    post surgery use of opioids



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total hip replacement or total knee replacement
  • 1 year membership with KPNW prior to enrollment

Exclusion Criteria:

  • managed by pain clinic, in other pain management trial
  • patients at low risk of persistent opioid use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576392


Sponsors and Collaborators
Kaiser Permanente
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: David H Smith, RPh, PhD Kaiser Permanente NW
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02576392    
Other Study ID Numbers: FDA BAA HHSF223201400146C
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms