Trial Outcomes & Findings for Smoking Cessation in Rural Hospitals (NCT NCT01063972)

Last Updated: 2019-04-08

Results Overview

Participant-reported 7-day point prevalence abstinence from cigarettes, validated by salivary cotinine (\< 15ng/ml) or proxy. Participants who did not respond to the survey were considered current smokers.

Recruitment status

COMPLETED

Study phase

Target enrollment

606 participants

Primary outcome timeframe

12 months

Results posted on

2019-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Centralized Disease Management (CDM) Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Overall Study STARTED	310	296
Overall Study COMPLETED	296	284
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Centralized Disease Management (CDM) Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Overall Study Death	12	11
Overall Study Incarcerated	2	1

Baseline Characteristics

Smoking Cessation in Rural Hospitals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Centralized Disease Management (CDM) n=310 Participants Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=296 Participants Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.	Total n=606 Participants Total of all reporting groups
Age, Continuous	50.6 years STANDARD_DEVIATION 12.89 • n=99 Participants	51.0 years STANDARD_DEVIATION 11.82 • n=107 Participants	50.8 years STANDARD_DEVIATION 12.37 • n=206 Participants
Sex: Female, Male Female	194 Participants n=99 Participants	189 Participants n=107 Participants	383 Participants n=206 Participants
Sex: Female, Male Male	116 Participants n=99 Participants	107 Participants n=107 Participants	223 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=99 Participants	9 Participants n=107 Participants	34 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	285 Participants n=99 Participants	287 Participants n=107 Participants	572 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	12 Participants n=99 Participants	12 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	14 Participants n=99 Participants	12 Participants n=107 Participants	26 Participants n=206 Participants
Race (NIH/OMB) White	278 Participants n=99 Participants	270 Participants n=107 Participants	548 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants	2 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment United States	310 participants n=99 Participants	296 participants n=107 Participants	606 participants n=206 Participants
Cigarettes smoked per day	19.3 cigarettes/day STANDARD_DEVIATION 9.99 • n=99 Participants	19.7 cigarettes/day STANDARD_DEVIATION 10.84 • n=107 Participants	19.4 cigarettes/day STANDARD_DEVIATION 10.41 • n=206 Participants
Smokes within 30 minutes of waking	257 Participants n=99 Participants	244 Participants n=107 Participants	501 Participants n=206 Participants
Fagerstrom score (heavy nicotine dependence)	142 Participants n=99 Participants	168 Participants n=107 Participants	310 Participants n=206 Participants
Motivation to quit smoking	9.3 units on a scale STANDARD_DEVIATION 1.34 • n=99 Participants	9.2 units on a scale STANDARD_DEVIATION 1.60 • n=107 Participants	9.3 units on a scale STANDARD_DEVIATION 1.47 • n=206 Participants
Confidence to quit smoking	7.1 units on a scale STANDARD_DEVIATION 2.61 • n=99 Participants	6.8 units on a scale STANDARD_DEVIATION 2.45 • n=107 Participants	7.0 units on a scale STANDARD_DEVIATION 2.53 • n=206 Participants
Planning to quit smoking in the next 30 days	303 Participants n=99 Participants	285 Participants n=107 Participants	588 Participants n=206 Participants
Quit attempted in the past 6 months	169 Participants n=99 Participants	154 Participants n=107 Participants	323 Participants n=206 Participants
Previous use of quit smoking medication	192 Participants n=99 Participants	199 Participants n=107 Participants	391 Participants n=206 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Participants who were deceased or incarcerated at month 12 were excluded from analysis.

Outcome measures

Outcome measures
Measure	Centralized Disease Management (CDM) n=296 Participants Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=284 Participants Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated	57 Participants	48 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Participants who were deceased or incarcerated at month 3 were excluded from analysis.

7-day point prevalence abstinence at 3 months, self-reported. Participants who did not respond were considered smokers.

Outcome measures

Outcome measures
Measure	Centralized Disease Management (CDM) n=303 Participants Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=292 Participants Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported	86 Participants	70 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants who were deceased or incarcerated at month 6 were excluded from the analysis.

7-day point prevalence abstinence at 6 months, self-reported. Participants who did not respond were considered smokers.

Outcome measures

Outcome measures
Measure	Centralized Disease Management (CDM) n=301 Participants Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=290 Participants Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported	64 Participants	56 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants who were deceased or incarcerated at month 6 were excluded from the analysis.

7-day point prevalence abstinence at 12 months, self-reported. Participants who did not respond were considered smokers.

Outcome measures

Outcome measures
Measure	Centralized Disease Management (CDM) n=296 Participants Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=284 Participants Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported	73 Participants	63 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Excludes participants who were deceased or incarcerated at month 6, or who did not report on pharmacotherapy use.

Outcome measures

Outcome measures
Measure	Centralized Disease Management (CDM) n=264 Participants Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=254 Participants Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months Any medication	145 Participants	141 Participants
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months Nicotine replacement therapy	106 Participants	112 Participants
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months Prescription medication	58 Participants	45 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Includes only participants eligible to enter into Cycle 2 counseling (those who reported smoking at month 6). Excludes participants who were deceased or incarcerated at month 12, or who did not report on pharmacotherapy use.

Outcome measures

Outcome measures
Measure	Centralized Disease Management (CDM) n=153 Participants Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=161 Participants Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months Any medication	80 Participants	68 Participants
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months Nicotine replacement therapy	50 Participants	50 Participants
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months Prescription medication	46 Participants	30 Participants

Adverse Events

Centralized Disease Management (CDM)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 12 deaths

Counseling (C)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Centralized Disease Management (CDM) n=310 participants at risk Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=296 participants at risk Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Psychiatric disorders Suicidal Ideation	0.32% 1/310 • Number of events 1 • 12 months	0.34% 1/296 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	Centralized Disease Management (CDM) n=310 participants at risk Experimental: 1 Centralized disease management Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider	Counseling (C) n=296 participants at risk Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services.
Product Issues Oral discomfort	0.32% 1/310 • Number of events 1 • 12 months	0.00% 0/296 • 12 months
Product Issues Dizziness	0.32% 1/310 • Number of events 1 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Change in affect	0.65% 2/310 • Number of events 2 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Sleep disturbance	0.32% 1/310 • Number of events 1 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Headache	0.32% 1/310 • Number of events 1 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Nausea	0.32% 1/310 • Number of events 1 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Tremors	0.00% 0/310 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Lightheadedness	0.00% 0/310 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Local skin reaction	0.32% 1/310 • Number of events 1 • 12 months	0.00% 0/296 • 12 months
Renal and urinary disorders Loss of bladder control	0.00% 0/310 • 12 months	0.34% 1/296 • Number of events 1 • 12 months
Product Issues Constipation	0.00% 0/310 • 12 months	0.34% 1/296 • Number of events 1 • 12 months

Additional Information

Sharon Fitzgerald, MPH

University of Kansas Medical Center

Phone: 913-588-3488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place