NCT03359031

Brief Summary

This study is a prospective, randomized trial. Our study aims to study the effects of perioperative patient education about compartment syndrome on patients' perception of their own pain, amount of opioid medication utilization, and rate of diagnosis of compartment syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 27, 2017

Last Update Submit

November 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • narcotic consumption

    Perioperative

    total opioid consumption from surgery through 30 days post-op

Study Arms (2)

No patient education

NO INTERVENTION

This group of patients will not receive any additional information beyond standard of care educational pamphlets provided by the hospital.

Patient education

OTHER

This group of patients will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.

Other: Patient education

Interventions

This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.

Patient education

Eligibility Criteria

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

You may qualify if:

  • Patients with lower extremity trauma at risk for developing compartment syndrome specifically tibial plateau fractures, tibial/fibular shaft fractures, pilon fractures, and crush injuries.

You may not qualify if:

  • Patients with an extensive history of narcotic medication or drug use, polytrauma patients, and non-primary English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

November 13, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations