NCT02440529

Brief Summary

In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

May 7, 2015

Last Update Submit

April 24, 2018

Conditions

Orthopaedic Decision Making

Outcome Measures

Primary Outcomes (1)

  • Patient Comprehension

    Knowledge-Based Question

    20 minutes

Study Arms (2)

(Intervention Group)

ACTIVE COMPARATOR

The discussion about how smoking cigarettes impacts patient orthopaedic management plus aid

Behavioral: Intervention

(Control Group)

ACTIVE COMPARATOR

The discussion about how smoking cigarettes impacts patient orthopaedic management.

Behavioral: Verbal Group

Interventions

InterventionBEHAVIORAL

Discussion

(Intervention Group)
Verbal GroupBEHAVIORAL

Detailed Discussion

(Control Group)

Eligibility Criteria

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

You may qualify if:

  • Patients 18 year old or older,
  • daily smoker
  • inpatient post fracture operation,
  • patient that have never received an orthopaedic related smoking cessation discussion

You may not qualify if:

  • Younger than 18,
  • patients unable to provide consent
  • patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Nkem Egekeze, MD

    UMKC DEPT OF ORTHOPAEDIC SURGERY

    PRINCIPAL INVESTIGATOR

  • Jonathan Dubin, MD

    UMKC DEPT OF ORTHOPAEDIC SURGERY

    STUDY DIRECTOR

  • Karen Williams, PhD

    UMKC DEPT OF BIOINFORMATICS

    STUDY DIRECTOR

  • Akin Cil, MD

    UMKC DEPT OF ORTHOPAEDIC SURGERY

    STUDY DIRECTOR

  • Mark Bernhardt, MD

    UMKC DEPT OF ORTHOPAEDIC SURGERY

    STUDY CHAIR

  • Dane Church, MD

    UMKC DEPT OF ORTHOPAEDIC SURGERY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Researcher

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 12, 2015

Study Start

January 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(1)