Hospital-based Patient Navigation and Smoking Cessation
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/29/2018 |
| Start Date: | June 4, 2018 |
| End Date: | September 2019 |
Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial
In a pilot RCT, smokers hospitalized on the general internal medicine or family medicine
service will be randomized to: 1) enhanced traditional care (ETC), or 2) patient navigation
(PN). Patients will be assessed at 3 months for self-report of quitting, use of smoking
cessation medications, and use of counseling in the outpatient setting. Medical charts will
be reviewed to ascertain if a prescription for smoking cessation medications was sent to the
participants' pharmacy (primary outcome), if participants received inpatient tobacco
counseling from the Tobacco Treatment Service (TTS), and whether they had a diagnosis of
mental health and substance use.
service will be randomized to: 1) enhanced traditional care (ETC), or 2) patient navigation
(PN). Patients will be assessed at 3 months for self-report of quitting, use of smoking
cessation medications, and use of counseling in the outpatient setting. Medical charts will
be reviewed to ascertain if a prescription for smoking cessation medications was sent to the
participants' pharmacy (primary outcome), if participants received inpatient tobacco
counseling from the Tobacco Treatment Service (TTS), and whether they had a diagnosis of
mental health and substance use.
An EPIC programmer who works with the Inpatient Tobacco Treatment Program will identify
potential participants using EHR data each week.
Eligible patients who are interested in the study and provide informed consent will be
randomized and informed of the randomization assignment by the research assistant. We will
stratify randomization by participants' response regarding their plan to quit smoking ("in
the next month" or "more than a month from now"). A computer-generated sequence of random
numbers will assign treatment groups. Participants will be randomized to one of two treatment
arms: (1) standard of care, or (2) PN: a patient navigator to coordinate tobacco treatment
with the smoker's outpatient healthcare team and address any underlying social determinants
of health that are barriers to cessation (identified using a validated social determinants of
health screening tool).
Assessments. A trained research assistant will administer these assessments either in-person
or over the phone. The assessments require under 30 minutes to complete. The PI will also
conduct an in-depth interview with the patient navigator to explore barriers to successful
navigation. Outcome assessments will be conducted at baseline (prior to randomization) and at
3-months after randomization. Participants will be assessed at 3-months, for self-report of
quitting, use of smoking cessation medications, and use of counseling in the outpatient
setting.
Enhanced Traditional Care: Participants randomized to this group will receive a resource card
that has information on quitlines, BMC's outpatient program number, and websites for smoking
cessation.
Patient Navigation Intervention: This intervention is based on the Social Contextual Model, a
multi-level approach to health education which stresses the influence of life experiences
(e.g. stress and financial problems) and social relationships (e.g. social networks and
family roles) on the practice of health behaviors. Participants randomized into this group
will meet the trained navigator in person if she is available, or will be introduced by
telephone. Participants will receive up to ten hours of patient navigation, in person or over
the phone, over a three-month period. Patient navigation contacts will involve individual
counseling to help the patient achieve abstinence from smoking. Navigators will also screen
participants for social determinants of health which may be preventing them from quitting
smoking, using an adapted version of a validated social determinants of health screening
tool. Patient navigation intervention calls will use motivational interviewing (MI)
strategies to do the following: (1) Assess stage of change for smoking cessation; (2) Assess
and reinforce any prior abstinence from smoking and/or any efforts made to reduce or quit
smoking; (3) Explore the patient's motivation to quit smoking, drawing on recent illness,
financial situation, and family situation as appropriate; advise about the risks of smoking
and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5)
Explore potential barriers to using smoking cessation medications (e.g. lack of trust, cost,
misconceptions about treatment (e.g. that nicotine replacement therapy (NRT) is more harmful
than cigarettes); (6) Brainstorm strategies to address identified barriers; (7) Elicit
commitment to accept another patient navigation counseling call, discuss timing.
Minimum navigation intervention dose: completion of social determinants of health screener
and at least part of MI script (at least 1 item)
Navigator Training and Evaluation. A standard, validated motivational interviewing (MI)
booster training program will be provided to one navigator. Training will include information
about 1) tobacco dependence and treatment; and 2) barriers to treatment engagement among
poor/minority patients. Our navigator will also be trained in MI. This additional training
will take place over a half day and will focus on reviewing MI skills and delivery of the
navigator intervention. MI skills will be reviewed through didactics, demonstrations,
role-plays, and video. The navigator will be evaluated on both process (helpfulness, warmth,
empathy), and content (intervention adherence). Following training the principal investigator
(PI) will meet weekly with the navigator to ensure skill maintenance by reviewing audiotapes
of intervention calls and providing corrective feedback.
Preserving Internal Validity/Treatment Fidelity, and Program Tracking. The intervention is
manual-based. After each patient interaction, the navigator will complete a checklist of
intervention components that were delivered. We will use these checklists to ensure that the
intervention is delivered as intended, and to estimate intervention "dose" and treatment
exposure. 5 participant interactions will be audio taped with permission from the
participant. the PI will monitor tapes for protocol adherence.
Chart review. The research assistant will review participants' medical record to see if they
have talked to their doctor about quitting smoking, if they have been prescribed medications
to quit smoking, if they have attended a smoking cessation group at Boston Medical Center, if
they received tobacco counseling from TTS, and if they have reduced the number of cigarettes
or have quit smoking. We will collect data on mental health and substance use diagnoses. The
investigators define mental health and substance use as the presence of diagnosed mental
illness/substance use on the problem list/ annotations to problem list. the investigators
will also determine whether participants have participated in any smoking cessation
counseling sessions over the phone from the Massachusetts Quitworks Program.
potential participants using EHR data each week.
Eligible patients who are interested in the study and provide informed consent will be
randomized and informed of the randomization assignment by the research assistant. We will
stratify randomization by participants' response regarding their plan to quit smoking ("in
the next month" or "more than a month from now"). A computer-generated sequence of random
numbers will assign treatment groups. Participants will be randomized to one of two treatment
arms: (1) standard of care, or (2) PN: a patient navigator to coordinate tobacco treatment
with the smoker's outpatient healthcare team and address any underlying social determinants
of health that are barriers to cessation (identified using a validated social determinants of
health screening tool).
Assessments. A trained research assistant will administer these assessments either in-person
or over the phone. The assessments require under 30 minutes to complete. The PI will also
conduct an in-depth interview with the patient navigator to explore barriers to successful
navigation. Outcome assessments will be conducted at baseline (prior to randomization) and at
3-months after randomization. Participants will be assessed at 3-months, for self-report of
quitting, use of smoking cessation medications, and use of counseling in the outpatient
setting.
Enhanced Traditional Care: Participants randomized to this group will receive a resource card
that has information on quitlines, BMC's outpatient program number, and websites for smoking
cessation.
Patient Navigation Intervention: This intervention is based on the Social Contextual Model, a
multi-level approach to health education which stresses the influence of life experiences
(e.g. stress and financial problems) and social relationships (e.g. social networks and
family roles) on the practice of health behaviors. Participants randomized into this group
will meet the trained navigator in person if she is available, or will be introduced by
telephone. Participants will receive up to ten hours of patient navigation, in person or over
the phone, over a three-month period. Patient navigation contacts will involve individual
counseling to help the patient achieve abstinence from smoking. Navigators will also screen
participants for social determinants of health which may be preventing them from quitting
smoking, using an adapted version of a validated social determinants of health screening
tool. Patient navigation intervention calls will use motivational interviewing (MI)
strategies to do the following: (1) Assess stage of change for smoking cessation; (2) Assess
and reinforce any prior abstinence from smoking and/or any efforts made to reduce or quit
smoking; (3) Explore the patient's motivation to quit smoking, drawing on recent illness,
financial situation, and family situation as appropriate; advise about the risks of smoking
and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5)
Explore potential barriers to using smoking cessation medications (e.g. lack of trust, cost,
misconceptions about treatment (e.g. that nicotine replacement therapy (NRT) is more harmful
than cigarettes); (6) Brainstorm strategies to address identified barriers; (7) Elicit
commitment to accept another patient navigation counseling call, discuss timing.
Minimum navigation intervention dose: completion of social determinants of health screener
and at least part of MI script (at least 1 item)
Navigator Training and Evaluation. A standard, validated motivational interviewing (MI)
booster training program will be provided to one navigator. Training will include information
about 1) tobacco dependence and treatment; and 2) barriers to treatment engagement among
poor/minority patients. Our navigator will also be trained in MI. This additional training
will take place over a half day and will focus on reviewing MI skills and delivery of the
navigator intervention. MI skills will be reviewed through didactics, demonstrations,
role-plays, and video. The navigator will be evaluated on both process (helpfulness, warmth,
empathy), and content (intervention adherence). Following training the principal investigator
(PI) will meet weekly with the navigator to ensure skill maintenance by reviewing audiotapes
of intervention calls and providing corrective feedback.
Preserving Internal Validity/Treatment Fidelity, and Program Tracking. The intervention is
manual-based. After each patient interaction, the navigator will complete a checklist of
intervention components that were delivered. We will use these checklists to ensure that the
intervention is delivered as intended, and to estimate intervention "dose" and treatment
exposure. 5 participant interactions will be audio taped with permission from the
participant. the PI will monitor tapes for protocol adherence.
Chart review. The research assistant will review participants' medical record to see if they
have talked to their doctor about quitting smoking, if they have been prescribed medications
to quit smoking, if they have attended a smoking cessation group at Boston Medical Center, if
they received tobacco counseling from TTS, and if they have reduced the number of cigarettes
or have quit smoking. We will collect data on mental health and substance use diagnoses. The
investigators define mental health and substance use as the presence of diagnosed mental
illness/substance use on the problem list/ annotations to problem list. the investigators
will also determine whether participants have participated in any smoking cessation
counseling sessions over the phone from the Massachusetts Quitworks Program.
Inclusion Criteria:
1. ≥ 18 years of age
2. Hospitalized on the General Internal Medicine or Family Medicine service
3. Have a primary care provider at BMC
4. Smoked ≥1 cigarettes/day in the past month
5. Must have plans to quit smoking
6. Read, understand, speak English
7. Possession of a telephone (home or cell)
8. Able to consent
Exclusion Criteria:
1. Cannot give informed consent or participate in counseling due to psychiatric or
cognitive impairment or communication barrier
2. Admitted to surgical, obstetric or psychiatric units
3. Estimated life expectancy of <12 months
4. Medical instability
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