Smoking, TobaccoSTOPNCT02428244
Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients
A study testing Motivational Interviewing and Motivational Interviewing + Follow-up in people with Smoking, Tobacco and Fractures, Bone, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco, Fractures, Bone
- What is being tested?
- Motivational Interviewing and Motivational Interviewing + Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Shock Trauma Center
Baltimore, Maryland, 21201
About this study
Official title: Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients. A Prospective Randomized Trial
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.
Read the detailed description
Patients who elect to be enrolled in the study will receive an initial enrollment survey (attached, Initial Survey) and baseline exhaled carbon monoxide (see below) and be in one of three arms. The arms in brief include (1) standard of care with research follow-up (as mentioned in the below protocol, control arm), (2) standard of care + a 10-30 minute discussion while an inpatient in the hospital regarding the negative effects of smoking with regards to their traumatic injury with research follow-up, and finally (3) standard of care + a 10-30 minute discussion while an inpatient in the hospital regarding the negative effects of smoking with regards to their traumatic injury with research follow-up and follow-up with the investigators smoking educator.
Participants in arms 2 and 3 will receive their education session at the time of enrollment. Research follow-up (as outlined below) will be conducted at the time of normal clinic visits (to avoid unnecessary visits by the patient for the purposes of research), or over the phone if the patient is unable to make the appointment. Arm 3, which includes 'follow-up with the investigators smoking educator' will receive follow-up with the smoking educator at the time of their research follow-up, eliminating the need for additional visits.
Descriptions of arms:
Arm 1, Control: 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. The brochure/document that patients are given which details the resources available is standardized. Patients will be provided this, also they will be provided with a Quitline Brochure.
Arm 2, Standard of care + brief counseling: 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 consent/referral form .
Arm 2, Standard of care + brief counseling + extended follow-up: 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.
Research follow-up: All participants in the study will receive follow-up at approximate intervals of 2 weeks, 6 weeks, 3 months, and 6 months. These time points were selected as they most closely align with clinical follow-up. Patients will receive their research follow-up at the time of their scheduled clinical encounters, to prevent the participant from having to make additional visits. If the participants are unable to make the visits, or their clinical follow-up is not within 1 week of expected timepoint, follow-up will be attempted via phone. All patients during their follow-up visit will receive the follow-up survey. This survey includes the primary outcome, which is self-reported 7-day abstinence from smoking. Additionally, patients exhaled carbon monoxide level will be measured at these intervals using a standard carbon monoxide meter that is frequently used in research (Pico+ Smokerylyzer, Bedfont Scientific, Haddonfield, NJ, USA). A reference of 8ppm will be utilized to determine abstinence. Otherwise, no other deviation from the standard of care will occur. In the event that patients are unable to follow-up at these schedule intervals, attempt will be made to contact the participants over the phone to perform the survey, and if possible, arrange a visit to perform the exhaled carbon monoxide metering.
At all time points patients will have the ability to receive the informational materials or referral to the quitline that had been received at the time of enrollment.
Conclusion of the patients involvement in the study will occur at their 6-month follow-up visit.
Referral to the quitline will be recorded. Successful referral will be defined as patients who sign the referral form. As part of the standard usage of the quitline and permission of the participant, the quitline will notify us the participants progress via their fax-to-assist program. Information including number of phone calls, services utilized (nicotine patches, text messaging, etc.) will be provided, in addition to self-reported abstinence at 6 months. This will be recorded.
- Conditions
- Smoking, Tobacco, Fractures, Bone
- Being tested
- Motivational Interviewing, Motivational Interviewing + Follow-up
- Keywords
- Smoking, Cessation, Trauma, Fracture, Complications
- Medical subject headings
- Tobacco Smoking, Fractures, Bone, Smoking, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
Motivational Interviewing + Follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Motivational Interviewing + Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 7-day abstinence point prevalence at 2 weeks
Self-reported 7-day abstinence from smoking at 2 weeks
Measured: 2 weeks
Change in 7-day abstinence point prevalence at 6 weeks
Self-reported 7-day abstinence from smoking at 6 weeks
Measured: 6 weeks
Change in 7-day abstinence point prevalence at 3 months
Self-reported 7-day abstinence from smoking at 3 months
Measured: 3 months
Change in 7-day abstinence point prevalence at 6 months
Self-reported 7-day abstinence from smoking at 6 months
Measured: 6 months
Secondary outcomes (8)
Change in Use of the Quitline at 2 weeks
Successful referral and use of quitline at 2 weeks
Measured: 2 weeks
Change in Use of the Quitline at 6 weeks
Successful referral and use of quitline at 6 weeks
Measured: 6 weeks
Change in Use of the Quitline at 3 months
Successful referral and use of quitline at 3 months
Measured: 3 months
Change in Use of the Quitline at 6 months
Successful referral and use of quitline at 6 months
Measured: 6 months
Change in Exhaled Carbon Monoxide at 2 weeks
Abstinence defined as 8-ppm exhaled carbon monoxide at 2 weeks
Measured: 2 week
Change in Exhaled Carbon Monoxide at 6 weeks
Abstinence defined as 8-ppm exhaled carbon monoxide at 6 weeks
Measured: 6 weeks
Change in Exhaled Carbon Monoxide at 3 months
Abstinence defined as 8-ppm exhaled carbon monoxide at 3 months
Measured: 3 months
Change in Exhaled Carbon Monoxide at 6 months
Abstinence defined as 8-ppm exhaled carbon monoxide at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startNov 2014
- Primary completion24 Oct 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene
- Responsible party
- Principal investigator, Robert O'Toole, University of Maryland, Baltimore
- Investigators
- Paul E Matuszewski, MD, Study director, University of Maryland, Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428244
- Sponsor's protocol ID
- HP-00061647
- Acronym
- STOP
- Status last verified
- Sep 2019
- First submitted
- 12 Nov 2014
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24740664Stephens 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.
PubMed 24449933Lee 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.
PubMed 23636193Nasell 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.
PubMed 21886001Rabe 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.
PubMed 23024250Dohnke 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.
PubMed 22472171Fu 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.
PubMed 17978982Spencer 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.
PubMed 12271754DiClemente 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.
PubMed 2030191DiClemente 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.
PubMed 20176317Hajek 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.
PubMed 1859918Blumenthal 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.
PubMed 17478660Risser 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.
PubMed 2405112Chen 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.
PubMed 24345098Brugger 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.
PubMed 23873321
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients. A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02428244
- Acronym / sponsor ID
- STOP / HP-00061647
- Conditions
- Smoking, Tobacco, Fractures, Bone
- Keywords
- Smoking, Cessation, Trauma, Fracture, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene
- Study start
- Nov 2014
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who elect to be enrolled in the study will receive an initial enrollment survey (attached, Initial Survey) and baseline exhaled carbon monoxide (see below) and be in one of three arms. The arms in brief include (1) standard of care with research follow-up (as mentioned in the below protocol, control arm), (2) standard of care + a 10-30 minute discussion while an inpatient in the hospital regarding the negative effects of smoking with regards to their traumatic injury with research follow-up, and finally (3) standard of care + a 10-30 minute discussion while an inpatient in the hospital regarding the negative effects of smoking with regards to their traumatic injury with research follow-up and follow-up with the investigators smoking educator.
Participants in arms 2 and 3 will receive their education session at the time of enrollment. Research follow-up (as outlined below) will be conducted at the time of normal clinic visits (to avoid unnecessary visits by the patient for the purposes of research), or over the phone if the patient is unable to make the appointment. Arm 3, which includes 'follow-up with the investigators smoking educator' will receive follow-up with the smoking educator at the time of their research follow-up, eliminating the need for additional visits.
Descriptions of arms:
Arm 1, Control: 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. The brochure/document that patients are given which details the resources available is standardized. Patients will be provided this, also they will be provided with a Quitline Brochure.
Arm 2, Standard of care + brief counseling: 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 consent/referral form .
Arm 2, Standard of care + brief counseling + extended follow-up: 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.
Research follow-up: All participants in the study will receive follow-up at approximate intervals of 2 weeks, 6 weeks, 3 months, and 6 months. These time points were selected as they most closely align with clinical follow-up. Patients will receive their research follow-up at the time of their scheduled clinical encounters, to prevent the participant from having to make additional visits. If the participants are unable to make the visits, or their clinical follow-up is not within 1 week of expected timepoint, follow-up will be attempted via phone. All patients during their follow-up visit will receive the follow-up survey. This survey includes the primary outcome, which is self-reported 7-day abstinence from smoking. Additionally, patients exhaled carbon monoxide level will be measured at these intervals using a standard carbon monoxide meter that is frequently used in research (Pico+ Smokerylyzer, Bedfont Scientific, Haddonfield, NJ, USA). A reference of 8ppm will be utilized to determine abstinence. Otherwise, no other deviation from the standard of care will occur. In the event that patients are unable to follow-up at these schedule intervals, attempt will be made to contact the participants over the phone to perform the survey, and if possible, arrange a visit to perform the exhaled carbon monoxide metering.
At all time points patients will have the ability to receive the informational materials or referral to the quitline that had been received at the time of enrollment.
Conclusion of the patients involvement in the study will occur at their 6-month follow-up visit.
Referral to the quitline will be recorded. Successful referral will be defined as patients who sign the referral form. As part of the standard usage of the quitline and permission of the participant, the quitline will notify us the participants progress via their fax-to-assist program. Information including number of phone calls, services utilized (nicotine patches, text messaging, etc.) will be provided, in addition to self-reported abstinence at 6 months. This will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Motivational InterviewingPatients 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. |
| Standard of care + counseling/follow-up | Experimental | Behavioral: Motivational Interviewing + Follow-upPatients 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational 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. | Behavioural | Standard of care + brief counseling |
| Motivational Interviewing + Follow-upMotivational 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. | Behavioural | Standard of care + counseling/follow-up |
Primary outcome
Change in 7-day abstinence point prevalence at 2 weeks
Time frame: 2 weeks
Self-reported 7-day abstinence from smoking at 2 weeks
Change in 7-day abstinence point prevalence at 6 weeks
Time frame: 6 weeks
Self-reported 7-day abstinence from smoking at 6 weeks
Change in 7-day abstinence point prevalence at 3 months
Time frame: 3 months
Self-reported 7-day abstinence from smoking at 3 months
Change in 7-day abstinence point prevalence at 6 months
Time frame: 6 months
Self-reported 7-day abstinence from smoking at 6 months
8 secondary outcomes
Change in Use of the Quitline at 2 weeks
Time frame: 2 weeks
Change in Use of the Quitline at 6 weeks
Time frame: 6 weeks
Change in Use of the Quitline at 3 months
Time frame: 3 months
Change in Use of the Quitline at 6 months
Time frame: 6 months
Change in Exhaled Carbon Monoxide at 2 weeks
Time frame: 2 week
Change in Exhaled Carbon Monoxide at 6 weeks
Time frame: 6 weeks
Change in Exhaled Carbon Monoxide at 3 months
Time frame: 3 months
Change in Exhaled Carbon Monoxide at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Background: PubMed 24740664Scolaro 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.
- Background: PubMed 24449933Stephens 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.
- Background: PubMed 23636193Lee 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.
- Background: PubMed 21886001Nasell 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.
- Background: PubMed 23024250Rabe 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.
- Background: PubMed 22472171Dohnke 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.
- Background: PubMed 17978982Fu 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.
- Background: PubMed 12271754Spencer 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.
- Background: PubMed 2030191DiClemente 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.
- Background: PubMed 20176317DiClemente 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.
- Background: PubMed 1859918Hajek 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.
- Background: PubMed 17478660Blumenthal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E Matuszewski, MD study director
University of Maryland, Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Motivational Interviewing + Follow-up in people with Smoking, Tobacco and Fractures, Bone, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 7-day abstinence point prevalence at 2 weeks (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428244, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.