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Hospital-based Patient Navigation and Smoking Cessation

Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03452371
Enrollment
44
Registered
2018-03-02
Start date
2018-06-04
Completion date
2019-06-04
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Patient Navigation, Hospitalized smokers

Brief summary

In a pilot randomized controlled trial (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.

Detailed description

An Electronic Privacy Information Center(EPIC programmer who works with the Inpatient Tobacco Treatment Program will identify potential participants using electronic health record (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, Boston Medical Center (BMC) 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.

Interventions

BEHAVIORALPatient Navigation

Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations 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; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing.

BEHAVIORALEnhanced Traditional Care

Enhanced traditional care will include a resource card with information on quitlines, Boston Medical Center's (BMC's) Tobacco Treatment Center Program number, and websites for smoking cessation.

Sponsors

Boston University
CollaboratorOTHER
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Prescription for an FDA-approved Smoking Cessation MedicationThree monthsBased on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)

Secondary

MeasureTime frameDescription
Number of Participants With Self-reported Smoking CessationThree monthsSelf-report of 7-day point prevalence abstinence
Number of Participants With Utilization of Smoking Cessation MedicationThree monthsself-report use of any smoking cessation medications (e.g. nicotine replacement therapy (NRT) patch, gum, lozenges, varenicline)
Number of Participants With Stage of Change for Smoking CessationThree monthsBased on the Transtheoretical Model by Prochaska & DiClemente. The stages of change are: precontemplation, contemplation, preparation, action, maintenance, and relapse. Defined as moving from pre-contemplation to contemplation, or contemplation to preparation stage.
Mean Fagerstrom Test Score for Nicotine DependenceThree monthsStandard validated 6 item instrument for assessing the intensity of addiction to nicotine. The 3 yes/no items are scored from 0 to 1. The 3 multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Use of Other Tobacco Treatment SupportThree monthsSelf-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.

Countries

United States

Participant flow

Participants by arm

ArmCount
Enhanced Traditional Care
Participants in this arm will receive usual care to help with smoking cessation offered to all patients who are smokers and some additional resources they can access for support. Enhanced Traditional Care: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
21
Patient Navigation Intervention
Participants in this arm will meet with the trained patient navigator either in-person if she is available, or by telephone. They will receive up to ten hours of patient navigation over three months. Patient Navigation: Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations 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; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing.
23
Total44

Baseline characteristics

CharacteristicTotalEnhanced Traditional CarePatient Navigation Intervention
Age, Continuous54.9 years
STANDARD_DEVIATION 13
52.6 years
STANDARD_DEVIATION 15
57 years
STANDARD_DEVIATION 10.1
Intent to stop smoking
Beyond 30 days
17 Participants8 Participants9 Participants
Intent to stop smoking
Within 30 days
27 Participants13 Participants14 Participants
Mean cigarettes per day11.4 cigarettes
STANDARD_DEVIATION 10.1
11.3 cigarettes
STANDARD_DEVIATION 10.1
11.4 cigarettes
STANDARD_DEVIATION 10.4
Mean Fagerstrom test score for nicotine dependence3.8 scores on a scale
STANDARD_DEVIATION 2.6
3.8 scores on a scale
STANDARD_DEVIATION 2.8
3.7 scores on a scale
STANDARD_DEVIATION 2.5
Mean quit attempt in past year1.6 quit attempts
STANDARD_DEVIATION 2.2
1.7 quit attempts
STANDARD_DEVIATION 2.7
1.5 quit attempts
STANDARD_DEVIATION 1.7
Mean years smoked37.5 years
STANDARD_DEVIATION 15.5
34.8 years
STANDARD_DEVIATION 18.2
39.9 years
STANDARD_DEVIATION 12.7
Race/Ethnicity, Customized
Hispanic (any race)
2 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
27 Participants12 Participants15 Participants
Race/Ethnicity, Customized
Non-Hispanic White
9 Participants3 Participants6 Participants
Race/Ethnicity, Customized
Other/unknown
6 Participants5 Participants1 Participants
Region of Enrollment
United States
44 participants21 participants23 participants
Sex: Female, Male
Female
25 Participants8 Participants17 Participants
Sex: Female, Male
Male
19 Participants13 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 23
other
Total, other adverse events
0 / 210 / 23
serious
Total, serious adverse events
0 / 210 / 23

Outcome results

Primary

Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication

Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)

Time frame: Three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Enhanced Traditional CareNumber of Participants With Prescription for an FDA-approved Smoking Cessation Medication9 Participants
Patient Navigation InterventionNumber of Participants With Prescription for an FDA-approved Smoking Cessation Medication11 Participants
Secondary

Mean Fagerstrom Test Score for Nicotine Dependence

Standard validated 6 item instrument for assessing the intensity of addiction to nicotine. The 3 yes/no items are scored from 0 to 1. The 3 multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.

Time frame: Three months

ArmMeasureValue (MEAN)Dispersion
Enhanced Traditional CareMean Fagerstrom Test Score for Nicotine Dependence1.9 scores on a scaleStandard Deviation 1.9
Patient Navigation InterventionMean Fagerstrom Test Score for Nicotine Dependence3 scores on a scaleStandard Deviation 2.6
Secondary

Number of Participants With Self-reported Smoking Cessation

Self-report of 7-day point prevalence abstinence

Time frame: Three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Enhanced Traditional CareNumber of Participants With Self-reported Smoking Cessation1 Participants
Patient Navigation InterventionNumber of Participants With Self-reported Smoking Cessation2 Participants
Secondary

Number of Participants With Stage of Change for Smoking Cessation

Based on the Transtheoretical Model by Prochaska & DiClemente. The stages of change are: precontemplation, contemplation, preparation, action, maintenance, and relapse. Defined as moving from pre-contemplation to contemplation, or contemplation to preparation stage.

Time frame: Three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Enhanced Traditional CareNumber of Participants With Stage of Change for Smoking Cessation3 Participants
Patient Navigation InterventionNumber of Participants With Stage of Change for Smoking Cessation4 Participants
Secondary

Number of Participants With Utilization of Smoking Cessation Medication

self-report use of any smoking cessation medications (e.g. nicotine replacement therapy (NRT) patch, gum, lozenges, varenicline)

Time frame: Three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Enhanced Traditional CareNumber of Participants With Utilization of Smoking Cessation Medication8 Participants
Patient Navigation InterventionNumber of Participants With Utilization of Smoking Cessation Medication7 Participants
Secondary

Use of Other Tobacco Treatment Support

Self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.

Time frame: Three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Enhanced Traditional CareUse of Other Tobacco Treatment Support0 Participants
Patient Navigation InterventionUse of Other Tobacco Treatment Support2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026