An interventional study of Patient Navigation and Enhanced Traditional Care in Smoking Cessation, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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.
Behavioral: Enhanced Traditional Care
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.
Behavioral: 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.
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.
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
Number of Participants With Self-reported Smoking Cessation
Self-report of 7-day point prevalence abstinence
Time frame: Three months
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
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
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
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
| Milestone | Enhanced Traditional Care | Patient Navigation Intervention |
|---|---|---|
| Started | 21 | 23 |
| Completed | 21 | 23 |
| Not completed | 0 | 0 |
Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)
| Participants | Enhanced Traditional Care | Patient Navigation Intervention |
|---|---|---|
| Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication | 9 | 11 |
Self-report of 7-day point prevalence abstinence
| Participants | Enhanced Traditional Care | Patient Navigation Intervention |
|---|---|---|
| Number of Participants With Self-reported Smoking Cessation | 1 | 2 |
self-report use of any smoking cessation medications (e.g. nicotine replacement therapy (NRT) patch, gum, lozenges, varenicline)
| Participants | Enhanced Traditional Care | Patient Navigation Intervention |
|---|---|---|
| Number of Participants With Utilization of Smoking Cessation Medication | 8 | 7 |
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.
| Participants | Enhanced Traditional Care | Patient Navigation Intervention |
|---|---|---|
| Number of Participants With Stage of Change for Smoking Cessation | 3 | 4 |
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.
| scores on a scale | Enhanced Traditional Care | Patient Navigation Intervention |
|---|---|---|
| Mean Fagerstrom Test Score for Nicotine Dependence | 1.9 ± 1.9 | 3 ± 2.6 |
Self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.
| Participants | Enhanced Traditional Care | Patient Navigation Intervention |
|---|---|---|
| Use of Other Tobacco Treatment Support | 0 | 2 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Traditional Care | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Patient Navigation Intervention | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| Mean | 52.6 ± 15 | 57 ± 10.1 | 54.9 ± 13 |
| Sex: Female, Male(Participants) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| Female | 8 | 17 | 25 |
| Male | 13 | 6 | 19 |
| Race/Ethnicity, Customized(Participants) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| Non-Hispanic White | 3 | 6 | 9 |
| Non-Hispanic Black | 12 | 15 | 27 |
| Hispanic (any race) | 1 | 1 | 2 |
| Other/unknown | 5 | 1 | 6 |
| Region of Enrollment(participants) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| United States | 21 | 23 | 44 |
| Intent to stop smoking(Participants) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| Within 30 days | 13 | 14 | 27 |
| Beyond 30 days | 8 | 9 | 17 |
| Mean cigarettes per day(cigarettes) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| Mean | 11.3 ± 10.1 | 11.4 ± 10.4 | 11.4 ± 10.1 |
| Mean years smoked(years) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| Mean | 34.8 ± 18.2 | 39.9 ± 12.7 | 37.5 ± 15.5 |
| Mean Fagerstrom test score for nicotine dependence(scores on a scale) | Enhanced Traditional Care | Patient Navigation Intervention | Total |
|---|---|---|---|
| Mean | 3.8 ± 2.8 | 3.7 ± 2.5 | 3.8 ± 2.6 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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