Hospital-based Patient Navigation and Smoking Cessation
|ClinicalTrials.gov Identifier: NCT03452371|
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Patient Navigation Behavioral: Enhanced Traditional Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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)
- Self-reported smoking cessation [ Time Frame: Three months ]Self-report of 7-day point prevalence abstinence
- Utilization of smoking cessation medication [ Time Frame: Three months ]self-report use of any smoking cessation medications (e.g. NRT patch, gum, lozenges, varenicline)
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452371
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Karen Lasser, MD MPH||Boston Medical Center|