Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients

NCT02428244 | Completed DMC

• 1 other identifier: HP-00061647
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known that smoking has deleterious effects to fracture/broken bone outcomes. Complications associated with smoking can be mitigated by smoking cessation. Initiating smoking cessation programs while patients are in the inpatient hospital setting has shown to be an opportune time to enroll patients in a smoking cessation program. The goal of this study is to determine if inpatient smoking counseling with/without follow-up is superior to the standard smoking cessation information associated with admission to a hospital facility.

Conditions

Smoking, Tobacco; Fractures, Bone

Keywords

Smoking; Cessation; Trauma; Fracture; Complications

Outcome Measures

Primary Outcomes (4)

• Change in 7-day abstinence point prevalence at 2 weeks

  Self-reported 7-day abstinence from smoking at 2 weeks

  2 weeks

• Change in 7-day abstinence point prevalence at 6 weeks

  Self-reported 7-day abstinence from smoking at 6 weeks

  6 weeks

• Change in 7-day abstinence point prevalence at 3 months

  Self-reported 7-day abstinence from smoking at 3 months

  3 months

• Change in 7-day abstinence point prevalence at 6 months

  Self-reported 7-day abstinence from smoking at 6 months

  6 months

Secondary Outcomes (8)

• Change in Use of the Quitline at 2 weeks

  2 weeks

• Change in Use of the Quitline at 6 weeks

  6 weeks

• Change in Use of the Quitline at 3 months

  3 months

• Change in Use of the Quitline at 6 months

  6 months

• Change in Exhaled Carbon Monoxide at 2 weeks

  2 week

Study Arms (3)

Arm 1, Control

NO INTERVENTION

Standard of care intervention: All patients at the University as a standard of care receive informational materials about smoking cessation. They are referred to the patient resource center at our institution. Patients will be provided this, also they will be provided with a smoking cessation Quitline Brochure

Standard of care + brief counseling

EXPERIMENTAL

Patients who are randomized into this arm will receive the standard of care (outlined above). Additionally, patients will also receive a smoking education/counseling session. Patients will receive 10-30 minutes of guided discussion regarding the risks and benefits with regards to smoking and the healing of their traumatic injuries. The smoking educators, who will be trained in accordance with the guidelines provided by MdQuit.org will utilize motivational interviewing techniques to enhance interest in quitting. Patients will receive a description of the quitline, and the quitlined will be the recommended resource. If patients elect to enroll in the quitline, they will be consented using the standardized quitline protocols.

Behavioral: Motivational Interviewing

Standard of care + counseling/follow-up

EXPERIMENTAL

Patients who are randomized into this arm will receive the same intervention as patients in Arm 2, except when patients arrive for their follow-up, the smoking educator will "check-in" with their progress for approximately 5 minutes. The techniques utilized during this check-in visit will include repetition of previously described motivational interviewing, at this point patients who elect to be referred to the quitline will be given this opportunity.

Behavioral: Motivational Interviewing + Follow-up

Interventions

Motivational Interviewing BEHAVIORAL

Motivational Interviewing coupled with education will be provided to help participants understand the risks associated with smoking and their fracture care. They will be referred to the quitline.

Standard of care + brief counseling

Motivational Interviewing + Follow-up BEHAVIORAL

Motivational Interviewing coupled with education will be provided to help participants understand the risks associated with smoking and their fracture care. They will be referred to the quitline. In this intervention, the participants will receive additional motivational interviewing sessions at 2 weeks, 6 weeks, 3 months and 6 months.

Standard of care + counseling/follow-up

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active smoker (defined as having smoked some days or every day within the last six months
• Identifying with having some interest in quitting smoking
• Sustained an orthopaedic injury requiring surgery
• Age 18 or older
• Following up at our institution
• Ability to consent within 3 weeks of first operative intervention
• Anticipated acute hospital discharge before first follow-up (2-3 weeks)
• Cognitive ability to consent

You may not qualify if:

• Age 80 or older
• Cognitive Inability to consent
• Having previously utilized the Maryland Quitline
• Not having a reliable phone line (i.e. conventional land line or cell phone)
• Inability or refusal to follow-up at the designated follow-up time points

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Maryland Department of Health and Mental Hygiene: collaborator

Study Sites (1)

University of Maryland, Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (17)

• Scolaro JA, Schenker ML, Yannascoli S, Baldwin K, Mehta S, Ahn J. Cigarette smoking increases complications following fracture: a systematic review. J Bone Joint Surg Am. 2014 Apr 16;96(8):674-81. doi: 10.2106/JBJS.M.00081.

  PMID: 24740664 BACKGROUND

• Stephens BF, Murphy A, Mihalko WM. The effects of nutritional deficiencies, smoking, and systemic disease on orthopaedic outcomes. J Bone Joint Surg Am. 2013 Dec 4;95(23):2152-7. doi: 10.2106/00004623-201312040-00010. No abstract available.

  PMID: 24449933 BACKGROUND

• Lee JJ, Patel R, Biermann JS, Dougherty PJ. The musculoskeletal effects of cigarette smoking. J Bone Joint Surg Am. 2013 May 1;95(9):850-9. doi: 10.2106/JBJS.L.00375.

  PMID: 23636193 BACKGROUND

• Nasell H, Ottosson C, Tornqvist H, Linde J, Ponzer S. The impact of smoking on complications after operatively treated ankle fractures--a follow-up study of 906 patients. J Orthop Trauma. 2011 Dec;25(12):748-55. doi: 10.1097/BOT.0b013e318213f217.

  PMID: 21886001 BACKGROUND

• Rabe GL, Wellmann J, Bagos P, Busch MA, Hense HW, Spies C, Weiss-Gerlach E, McCarthy W, Gareca Arizaga MJ, Neuner B. Efficacy of emergency department-initiated tobacco control--systematic review and meta-analysis of randomized controlled trials. Nicotine Tob Res. 2013 Mar;15(3):643-55. doi: 10.1093/ntr/nts212. Epub 2012 Sep 27.

  PMID: 23024250 BACKGROUND

• Dohnke B, Ziemann C, Will KE, Weiss-Gerlach E, Spies CD. Do hospital treatments represent a 'teachable moment' for quitting smoking? A study from a stage-theoretical perspective. Psychol Health. 2012;27(11):1291-307. doi: 10.1080/08870446.2012.672649. Epub 2012 Apr 4.

  PMID: 22472171 BACKGROUND

• Fu SS, McFall M, Saxon AJ, Beckham JC, Carmody TP, Baker DG, Joseph AM. Post-traumatic stress disorder and smoking: a systematic review. Nicotine Tob Res. 2007 Nov;9(11):1071-84. doi: 10.1080/14622200701488418.

  PMID: 17978982 BACKGROUND

• Spencer L, Pagell F, Hallion ME, Adams TB. Applying the transtheoretical model to tobacco cessation and prevention: a review of literature. Am J Health Promot. 2002 Sep-Oct;17(1):7-71. doi: 10.4278/0890-1171-17.1.7.

  PMID: 12271754 BACKGROUND

• DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.

  PMID: 2030191 BACKGROUND

• DiClemente CC, Delahanty JC, Fiedler RM. The journey to the end of smoking: A personal and population perspective. Am J Prev Med. 2010 Mar;38(3 Suppl):S418-28. doi: 10.1016/j.amepre.2009.12.010.

  PMID: 20176317 BACKGROUND

• Hajek P. Individual differences in difficulty quitting smoking. Br J Addict. 1991 May;86(5):555-8. doi: 10.1111/j.1360-0443.1991.tb01807.x.

  PMID: 1859918 BACKGROUND

• Blumenthal DS. Barriers to the provision of smoking cessation services reported by clinicians in underserved communities. J Am Board Fam Med. 2007 May-Jun;20(3):272-9. doi: 10.3122/jabfm.2007.03.060115.

  PMID: 17478660 BACKGROUND

• Risser NL, Belcher DW. Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial. J Gen Intern Med. 1990 Jan-Feb;5(1):16-22. doi: 10.1007/BF02602303.

  PMID: 2405112 BACKGROUND

• Chen CC, Chang CH, Tsai YC, Tseng CW, Tu ML, Wang CC, Lin MC, Liu SF. Utilizing exhaled carbon monoxide measurement with self-declared smoking cessation: enhancing abstinence effectiveness in Taiwanese outpatients. Clin Respir J. 2015 Jan;9(1):7-13. doi: 10.1111/crj.12096. Epub 2014 Jan 17.

  PMID: 24345098 BACKGROUND

• Brugger OE, Frei M, Sendi P, Reichart PA, Ramseier CA, Bornstein MM. Assessment of smoking behaviour in a dental setting: a 1-year follow-up study using self-reported questionnaire data and exhaled carbon monoxide levels. Clin Oral Investig. 2014 Apr;18(3):909-15. doi: 10.1007/s00784-013-1036-x. Epub 2013 Jul 20.

  PMID: 23873321 BACKGROUND

• Javors MA, Hatch JP, Lamb RJ. Cut-off levels for breath carbon monoxide as a marker for cigarette smoking. Addiction. 2005 Feb;100(2):159-67. doi: 10.1111/j.1360-0443.2004.00957.x.

  PMID: 15679745 BACKGROUND

• Rigotti NA, Regan S, Levy DE, Japuntich S, Chang Y, Park ER, Viana JC, Kelley JH, Reyen M, Singer DE. Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):719-28. doi: 10.1001/jama.2014.9237.

  PMID: 25138333 BACKGROUND

MeSH Terms

Conditions

Tobacco Smoking; Fractures, Bone; Smoking; Wounds and Injuries

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paul E Matuszewski, MD

  University of Maryland, Department of Orthopaedics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Orthopaedic Trauma, Department of Orthopaedics

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: April 28, 2015
• Study Start: November 1, 2014
• Primary Completion: October 24, 2018
• Study Completion: April 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (1)