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
About this trial
This is an interventional health services research trial for Post-operative Pain
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
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
NCT ID
NCT02576392
First Posted
October 13, 2015
Last Updated
June 2, 2017
Sponsor
Kaiser Permanente
Collaborators
Food and Drug Administration (FDA)
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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