Trial Outcomes & Findings for Pilot Study of Patient Navigation to Promote Smoking Cessation (NCT NCT01414036)
NCT ID: NCT01414036
Last Updated: 2016-03-21
Results Overview
This is a dichotomous variable, Y/N, based on a) completion of \> 1 quit line counseling session (based on self-report) OR b) \> 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of \> 1 session of a BMC smoking cessation group (medical record review).
COMPLETED
NA
47 participants
3 months
2016-03-21
Participant Flow
Participant milestones
| Measure |
Enhanced Traditional Care Control
This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources
|
Patient Navigation
Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
|
|---|---|---|
|
Received Allocated Intervention
STARTED
|
23
|
24
|
|
Received Allocated Intervention
COMPLETED
|
23
|
11
|
|
Received Allocated Intervention
NOT COMPLETED
|
0
|
13
|
|
Completed 3 Month Survey
STARTED
|
23
|
24
|
|
Completed 3 Month Survey
COMPLETED
|
14
|
19
|
|
Completed 3 Month Survey
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Patient Navigation to Promote Smoking Cessation
Baseline characteristics by cohort
| Measure |
Enhanced Traditional Care Control
n=23 Participants
This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources
|
Patient Navigation
n=24 Participants
Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.
This is a dichotomous variable, Y/N, based on a) completion of \> 1 quit line counseling session (based on self-report) OR b) \> 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of \> 1 session of a BMC smoking cessation group (medical record review).
Outcome measures
| Measure |
Enhanced Traditional Care Control
n=14 Participants
This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources
|
Patient Navigation
n=19 Participants
Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
|
|---|---|---|
|
Engagement in Smoking Cessation Treatment
|
7 participant
|
9 participant
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.
Stage of change is assessed at baseline and 3 months. Three months after study entry, 7 of patient navigation-intervention participants who had initially said that they did not have a time frame in mind for quitting reported that they now had a time frame in mind for quitting, relative to 1 of ETC-control participants.
Outcome measures
| Measure |
Enhanced Traditional Care Control
n=14 Participants
This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources
|
Patient Navigation
n=19 Participants
Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
|
|---|---|---|
|
Stage of Change With Regard to Smoking Cessation
|
1 participant
|
7 participant
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.
self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.
Outcome measures
| Measure |
Enhanced Traditional Care Control
n=14 Participants
This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources
|
Patient Navigation
n=19 Participants
Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
|
|---|---|---|
|
Use of Other Tobacco Treatment Support
|
6 participant
|
9 participant
|
Adverse Events
Enhanced Traditional Care Control
Patient Navigation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place