CClinicalTrials.gg
CompletedNCT03452371Updated Mar 31, 2020Results posted

Hospital-based Patient Navigation and Smoking Cessation

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

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • Patient Navigation
  • Hospitalized smokers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    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.

    Behavioral: Enhanced Traditional Care

  • Experimental
    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.

    Behavioral: Patient Navigation

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.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants With Self-reported Smoking Cessation

    Self-report of 7-day point prevalence abstinence

    Time frame: Three months

  2. 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

  3. 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

  4. 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

  5. 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

06

Results

Posted Mar 31, 2020

Participant flow

Participant flow — Overall Study
MilestoneEnhanced Traditional CarePatient Navigation Intervention
Started2123
Completed2123
Not completed00

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication
ParticipantsEnhanced Traditional CarePatient Navigation Intervention
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication911
SecondaryNumber of Participants With Self-reported Smoking Cessation

Self-report of 7-day point prevalence abstinence

Time frame:
Three months
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Smoking Cessation
ParticipantsEnhanced Traditional CarePatient Navigation Intervention
Number of Participants With Self-reported Smoking Cessation12
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Utilization of Smoking Cessation Medication
ParticipantsEnhanced Traditional CarePatient Navigation Intervention
Number of Participants With Utilization of Smoking Cessation Medication87
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Stage of Change for Smoking Cessation
ParticipantsEnhanced Traditional CarePatient Navigation Intervention
Number of Participants With Stage of Change for Smoking Cessation34
SecondaryMean 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
Reported as:
Mean · scores on a scale
Mean Fagerstrom Test Score for Nicotine Dependence
scores on a scaleEnhanced Traditional CarePatient Navigation Intervention
Mean Fagerstrom Test Score for Nicotine Dependence1.9 ± 1.93 ± 2.6
SecondaryUse 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
Reported as:
Count of participants · Participants
Use of Other Tobacco Treatment Support
ParticipantsEnhanced Traditional CarePatient Navigation Intervention
Use of Other Tobacco Treatment Support02

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enhanced Traditional Care0/21 (0%)0/21 (0%)0/21 (0%)
Patient Navigation Intervention0/23 (0%)0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Enhanced Traditional CarePatient Navigation InterventionTotal
Mean52.6 ± 1557 ± 10.154.9 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Enhanced Traditional CarePatient Navigation InterventionTotal
Female81725
Male13619
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Enhanced Traditional CarePatient Navigation InterventionTotal
Non-Hispanic White369
Non-Hispanic Black121527
Hispanic (any race)112
Other/unknown516
Region of Enrollment
Region of Enrollment(participants)Enhanced Traditional CarePatient Navigation InterventionTotal
United States212344
Intent to stop smoking
Intent to stop smoking(Participants)Enhanced Traditional CarePatient Navigation InterventionTotal
Within 30 days131427
Beyond 30 days8917
Mean cigarettes per day
Mean cigarettes per day(cigarettes)Enhanced Traditional CarePatient Navigation InterventionTotal
Mean11.3 ± 10.111.4 ± 10.411.4 ± 10.1
Mean years smoked
Mean years smoked(years)Enhanced Traditional CarePatient Navigation InterventionTotal
Mean34.8 ± 18.239.9 ± 12.737.5 ± 15.5
Mean Fagerstrom test score for nicotine dependence
Mean Fagerstrom test score for nicotine dependence(scores on a scale)Enhanced Traditional CarePatient Navigation InterventionTotal
Mean3.8 ± 2.83.7 ± 2.53.8 ± 2.6

1 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
08

References and documents

Publications

  • Lasser KE, Quintiliani LM, Truong V, Xuan Z, Murillo J, Jean C, Pbert L. Effect of Patient Navigation and Financial Incentives on Smoking Cessation Among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1798-1807. doi: 10.1001/jamainternmed.2017.4372. PubMed 29084312 ↗
  • Lasser KE, Kenst KS, Quintiliani LM, Wiener RS, Murillo J, Pbert L, Xuan Z, Bowen DJ. Patient navigation to promote smoking cessation among low-income primary care patients: a pilot randomized controlled trial. J Ethn Subst Abuse. 2013;12(4):374-90. doi: 10.1080/15332640.2013.819311. PubMed 24215228 ↗
  • Kendzor DE, Businelle MS, Poonawalla IB, Cuate EL, Kesh A, Rios DM, Ma P, Balis DS. Financial incentives for abstinence among socioeconomically disadvantaged individuals in smoking cessation treatment. Am J Public Health. 2015 Jun;105(6):1198-205. doi: 10.2105/AJPH.2014.302102. Epub 2014 Nov 13. PubMed 25393172 ↗
  • Sorensen G, Barbeau E, Hunt MK, Emmons K. Reducing social disparities in tobacco use: a social-contextual model for reducing tobacco use among blue-collar workers. Am J Public Health. 2004 Feb;94(2):230-9. doi: 10.2105/ajph.94.2.230. PubMed 14759932 ↗
  • Borrelli B, McQuaid EL, Novak SP, Hammond SK, Becker B. Motivating Latino caregivers of children with asthma to quit smoking: a randomized trial. J Consult Clin Psychol. 2010 Feb;78(1):34-43. doi: 10.1037/a0016932. PubMed 20099948 ↗
  • Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398. PubMed 17766528 ↗
  • Prochaska J, Redding C, Evers K. The Transtheoretical Model and Stages of Change. Health Behavior and Health Education: Theory, Research, and Practice.. Glanz K, Lewis FM, Rimer BK, editors. San Francisco: Jossey-Bass; 1997
  • Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x. PubMed 1932883 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03452371
Lead sponsor
Boston Medical Center
Collaborators
Boston University
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jun 4, 2018
Primary completion
Jun 4, 2019
Completion
Jun 4, 2019
Results posted
Mar 31, 2020
Last update
Mar 31, 2020

Study contacts

Karen Lasser, MD MPH
principal investigator · Boston Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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