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

Reducing the Use of Opioid Therapy Following Orthopedic Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 561
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average morphine equivalents	post surgery use of opioids	90 days

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Principal Investigator: David H Smith, RPh, PhD, Kaiser Permanente NW

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FDA BAA HHSF223201400146C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO