NCT02584881

Brief Summary

Using a quasi-experimental design the investigators will compare the effect of adopting and implementing a Safe Opioid Prescription Practice (SOPP) protocol within a Level 1 trauma service team compared to a Level 1 trauma service team implementing standard care.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

October 28, 2014

Last Update Submit

October 21, 2015

Conditions

OpioidsDrug Prescription

Outcome Measures

Primary Outcomes (1)

  • The frequency of implementation of the SOPP checklist in the intervention site compared to standard care site

    Up to 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

A safe opioid prescription protocol will be implemented with these trauma patients

Other: safe opioid prescription protocol

Control

NO INTERVENTION

Standard care at discharge will be implemented with these trauma patients

Interventions

safe opioid prescription protocolOTHER

When indicated a prescription for naloxone will be given to patients discharged with prescription opioids from the trauma services. All patients will receive information on safe opioid use and storage and methods for pain management.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Discharged to home from in-patient trauma services with a prescription for opioids
  • Responsible for own medication.
  • Cognitively capable of giving informed consent, can be contacted by telephone

You may not qualify if:

  • \< 18 years
  • Discharged to rehabilitative or nursing home care
  • Not discharged with prescribed opioids
  • Not responsible for own medication
  • No English speaking
  • Under arrest at time of in-patient care
  • Cannot be contacted by phone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 23, 2015

Study Start

December 1, 2014

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 23, 2015

Record last verified: 2014-10