Smoking Cessation Clinical Trial
Official title:
Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial
Verified date | March 2020 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 4, 2019 |
Est. primary completion date | June 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | Boston University Clinical Translational Science Institute |
United States,
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | Three months | |
Secondary | Number of Participants With Self-reported Smoking Cessation | Self-report of 7-day point prevalence abstinence | Three months | |
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) | Three months | |
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. |
Three months | |
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. | Three months | |
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. | Three months |
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