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

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.

Inclusion Criteria:

1. Active smoker (defined as having smoked some days or every day within the last six
months

2. Identifying with having some interest in quitting smoking

3. Sustained an orthopaedic injury requiring surgery

4. Age 18 or older

5. Following up at our institution

6. Ability to consent within 3 weeks of first operative intervention

7. Anticipated acute hospital discharge before first follow-up (2-3 weeks)

8. Cognitive ability to consent

Exclusion Criteria:

1. Age 80 or older

2. Cognitive Inability to consent

3. Having previously utilized the Maryland Quitline

4. Not having a reliable phone line (i.e. conventional land line or cell phone)

5. Inability or refusal to follow-up at the designated follow-up time points