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Trial record 12 of 2036 for:    Smoking Cessation

Hospital-based Patient Navigation and Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03452371
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : April 29, 2019
Information provided by (Responsible Party):
Boston Medical Center

Brief Summary:
In a pilot 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Patient Navigation Behavioral: Enhanced Traditional Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hospital-based Patient Navigation to Promote Smoking Cessation: a Pilot Randomized Controlled Trial
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

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.
Behavioral: Enhanced Traditional Care
Enhanced traditional care will include a resource card with information on quitlines, 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.
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.

Primary Outcome Measures :
  1. Prescription for an FDA-approved smoking cessation medication [ Time Frame: Three months ]
    Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)

Secondary Outcome Measures :
  1. Self-reported smoking cessation [ Time Frame: Three months ]
    Self-report of 7-day point prevalence abstinence

  2. Utilization of smoking cessation medication [ Time Frame: Three months ]
    self-report use of any smoking cessation medications (e.g. NRT patch, gum, lozenges, varenicline)

  3. 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.

  4. Fagerstrom Test 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.

  5. Use of other tobacco treatment support [ Time Frame: Three months ]
    Self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03452371

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
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Principal Investigator: Karen Lasser, MD MPH Boston Medical Center

Additional Information:
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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Responsible Party: Boston Medical Center Identifier: NCT03452371     History of Changes
Other Study ID Numbers: H-37040
1UL1TR001430 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:
Patient Navigation
Hospitalized smokers