Trial Outcomes & Findings for Hospital-based Patient Navigation and Smoking Cessation (NCT NCT03452371)
NCT ID: NCT03452371
Last Updated: 2020-03-31
Results Overview
Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Three months
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hospital-based Patient Navigation and Smoking Cessation
Baseline characteristics by cohort
| Measure |
Enhanced Traditional Care
n=21 Participants
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
Patient Navigation Intervention
n=23 Participants
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.
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 15 • n=93 Participants
|
57 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
54.9 years
STANDARD_DEVIATION 13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic (any race)
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other/unknown
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
23 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
Intent to stop smoking
Within 30 days
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Intent to stop smoking
Beyond 30 days
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Mean cigarettes per day
|
11.3 cigarettes
STANDARD_DEVIATION 10.1 • n=93 Participants
|
11.4 cigarettes
STANDARD_DEVIATION 10.4 • n=4 Participants
|
11.4 cigarettes
STANDARD_DEVIATION 10.1 • n=27 Participants
|
|
Mean years smoked
|
34.8 years
STANDARD_DEVIATION 18.2 • n=93 Participants
|
39.9 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
37.5 years
STANDARD_DEVIATION 15.5 • n=27 Participants
|
|
Mean Fagerstrom test score for nicotine dependence
|
3.8 scores on a scale
STANDARD_DEVIATION 2.8 • n=93 Participants
|
3.7 scores on a scale
STANDARD_DEVIATION 2.5 • n=4 Participants
|
3.8 scores on a scale
STANDARD_DEVIATION 2.6 • n=27 Participants
|
|
Mean quit attempt in past year
|
1.7 quit attempts
STANDARD_DEVIATION 2.7 • n=93 Participants
|
1.5 quit attempts
STANDARD_DEVIATION 1.7 • n=4 Participants
|
1.6 quit attempts
STANDARD_DEVIATION 2.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: Three monthsBased on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)
Outcome measures
| Measure |
Enhanced Traditional Care
n=21 Participants
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
Patient Navigation Intervention
n=23 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Three monthsSelf-report of 7-day point prevalence abstinence
Outcome measures
| Measure |
Enhanced Traditional Care
n=21 Participants
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
Patient Navigation Intervention
n=23 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Self-reported Smoking Cessation
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Three monthsself-report use of any smoking cessation medications (e.g. nicotine replacement therapy (NRT) patch, gum, lozenges, varenicline)
Outcome measures
| Measure |
Enhanced Traditional Care
n=21 Participants
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
Patient Navigation Intervention
n=23 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Utilization of Smoking Cessation Medication
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Three monthsBased 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.
Outcome measures
| Measure |
Enhanced Traditional Care
n=21 Participants
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
Patient Navigation Intervention
n=23 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Stage of Change for Smoking Cessation
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Three monthsStandard 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.
Outcome measures
| Measure |
Enhanced Traditional Care
n=12 Participants
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
Patient Navigation Intervention
n=14 Participants
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.
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.
|
|---|---|---|
|
Mean Fagerstrom Test Score for Nicotine Dependence
|
1.9 scores on a scale
Standard Deviation 1.9
|
3 scores on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Three monthsSelf-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.
Outcome measures
| Measure |
Enhanced Traditional Care
n=21 Participants
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: Enhanced traditional care will include a resource card with information on quitlines, BMC's Tobacco Treatment Center Program number, and websites for smoking cessation.
|
Patient Navigation Intervention
n=23 Participants
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.
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.
|
|---|---|---|
|
Use of Other Tobacco Treatment Support
|
0 Participants
|
2 Participants
|
Adverse Events
Enhanced Traditional Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Navigation Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karen Lasser
Boston Medical Center/ Boston University Schools of Medicine and Public Health
Phone: 617-414-6688
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place