The Impact of Orthopaedic Smoking Cessation Education on Cigarette Abstinence Self-Efficacy: A Randomized Controlled Trial

NCT02408809 | Completed DMC

• 1 other identifier: 15-247
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators of this study aim to evaluate the impact of a new orthopaedic related smoking cessation discussion on smoking behavior. Considering the high prevalence of patients who smoke and receive orthopaedic management, we are interested in determining whether an orthopaedic smoking cessation discussion impacts smoking abstinence self-efficacy over time compared to a general smoking cessation discussion.

Conditions

Cigarette Smoking

Keywords

Orthopaedic Smoking Cessation Discussion; Smoking Cessation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• SASEQ

  Smoking abstinence Self-Efficacy Questionnaire

  5 minutes

Secondary Outcomes (1)

• Patient Knowledge and Motivation to Quit

  less than 20 minutes

Study Arms (2)

Control

ACTIVE COMPARATOR

Behavioral: General Smoking Cessation Discussion

Intervention

ACTIVE COMPARATOR

Behavioral: Orthopaedic Related Smoking Cessation Discussion

Interventions

General Smoking Cessation Discussion BEHAVIORAL

This group receives the 5 A's of smoking cessation counseling incorporating how cigarette smoking negatively impacts general health (cancer, MI). 10 minutes in length.

Control

Orthopaedic Related Smoking Cessation Discussion BEHAVIORAL

The participants in this group receive a discussion including the 5 A's of smoking cessation counseling incorporating an orthopaedic related smoking cessation discussion about the effects of smoking cigarettes on the musculoskeletal system. 10 minutes in length.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily cigarette smokers (5 cigarettes or more a day for past year), 18 years of age or older, new orthopaedic management, native English speaker

You may not qualify if:

• Patients unable to provide consent, suffer an impairment (mental, psychiatric, hearing or sight), alcohol and illicit drug abusers, homeless, presently managed with a smoking cessation medication or counseling, living with a cigarette smoker, user of other tobacco products

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Study Officials

• Nkem Egekeze, MD

  UMKC DEPT OF ORTHOPAEDIC SURGERY

  PRINCIPAL INVESTIGATOR

• Akin Cil, MD

  UMKC DEPT OF ORTHOPAEDIC SURGERY

  STUDY DIRECTOR

• Karen Williams, PhD

  UMKC DEPT OF BIOINFORMATICS

  STUDY DIRECTOR

• James Bogener, MD

  UMKC DEPT OF ORTHOPAEDIC SURGERY

  STUDY DIRECTOR

• Mark Bernhardt, MD

  UMKC DEPT OF ORTHOPAEDIC SURGERY

  STUDY DIRECTOR

• Jonathan Dubin, MD

  UMKC DEPT OF ORTHOPAEDIC SURGERY

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 14, 2017

Record last verified: 2017-06