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

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-operative Pain

Eligibility Criteria

20 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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

    Usual Care

    Outcomes

    Primary Outcome Measures

    Average morphine equivalents
    post surgery use of opioids

    Secondary Outcome Measures

    Full Information

    First Posted
    October 13, 2015
    Last Updated
    June 2, 2017
    Sponsor
    Kaiser Permanente
    Collaborators
    Food and Drug Administration (FDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02576392
    Brief Title
    FDA: Lowering Orthopedic Opioid Dosing (FLOOD)
    Acronym
    FLOOD
    Official Title
    Reducing the Use of Opioid Therapy Following Orthopedic Surgery: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (undefined)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    March 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente
    Collaborators
    Food and Drug Administration (FDA)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Pain

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    561 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual Care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Average morphine equivalents
    Description
    post surgery use of opioids
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David H Smith, RPh, PhD
    Organizational Affiliation
    Kaiser Permanente NW
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    FDA: Lowering Orthopedic Opioid Dosing (FLOOD)

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