- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452371
Hospital-based Patient Navigation and Smoking Cessation
Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 18 years of age
- Hospitalized on the General Internal Medicine or Family Medicine service
- Have a primary care provider at BMC
- Smoked ≥1 cigarettes/day in the past month
- Must have plans to quit smoking
- Read, understand, speak English
- Possession of a telephone (home or cell)
- Able to consent
Exclusion Criteria:
- Cannot give informed consent or participate in counseling due to psychiatric or cognitive impairment or communication barrier
- Admitted to surgical, obstetric or psychiatric units
- Estimated life expectancy of <12 months
- Medical instability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication
Time Frame: Three months
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Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)
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Three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Self-reported Smoking Cessation
Time Frame: Three months
|
Self-report of 7-day point prevalence abstinence
|
Three months
|
Number of Participants With Utilization of Smoking Cessation Medication
Time Frame: Three months
|
self-report use of any smoking cessation medications (e.g.
nicotine replacement therapy (NRT) patch, gum, lozenges, varenicline)
|
Three months
|
Number of Participants With Stage of Change for Smoking Cessation
Time Frame: Three months
|
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. |
Three months
|
Mean Fagerstrom Test Score for Nicotine Dependence
Time Frame: Three months
|
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.
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Three months
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Use of Other Tobacco Treatment Support
Time Frame: Three months
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Self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.
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Three months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Lasser, MD MPH, Boston Medical Center
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-37040
- 1UL1TR001430 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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