Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02428244
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2014-11-12
Brief Title:
Lets STOP Now Trial Smoking in Trauma Orthopaedic Patients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Lets STOP Now Trial Smoking in Trauma Orthopaedic Patients A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP
Brief Summary:
It is well known that smoking has deleterious effects to fracturebroken 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 withwithout 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 brochuredocument 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 educationcounseling 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 MdQuitorg 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 consentreferral 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
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 brochuredocument 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 educationcounseling 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 MdQuitorg 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 consentreferral 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None