Hospital-based Patient Navigation and Smoking Cessation

NCT03452371 | Completed Results

• 2 other identifiers: H-370401UL1TR001430
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Patient Navigation; Hospitalized smokers

Outcome Measures

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)

  Three months

Secondary Outcomes (5)

• Number of Participants With Self-reported Smoking Cessation

  Three months

• Number of Participants With Utilization of Smoking Cessation Medication

  Three months

• Number of Participants With Stage of Change for Smoking Cessation

  Three months

• Mean Fagerstrom Test Score for Nicotine Dependence

  Three months

• Use of Other Tobacco Treatment Support

  Three months

Study Arms (2)

Enhanced Traditional Care

ACTIVE COMPARATOR

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

Patient Navigation Intervention

EXPERIMENTAL

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

Patient Navigation BEHAVIORAL

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.

Patient Navigation Intervention

Enhanced Traditional Care BEHAVIORAL

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.

Enhanced Traditional Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (8)

• 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.

  PMID: 29084312 BACKGROUND

• 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.

  PMID: 24215228 BACKGROUND

• 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.

  PMID: 25393172 BACKGROUND

• 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.

  PMID: 14759932 BACKGROUND

• 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.

  PMID: 20099948 BACKGROUND

• 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.

  PMID: 17766528 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 1932883 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Karen Lasser
• Organization: Boston Medical Center/ Boston University Schools of Medicine and Public Health

karen.lasser@bmc.org

617-414-6688

Study Officials

• Karen Lasser, MD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: June 4, 2018
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: March 31, 2020
• Results First Posted: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)