Trial Outcomes & Findings for Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans (NCT NCT00816036)

NCT ID: NCT00816036

Last Updated: 2015-04-27

Results Overview

This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 898 participants
• Primary outcome timeframe: 6 months post enrollment
• Results posted on: 2015-04-27

Participant Flow

Participant milestones

Measure	Pre-intervention Period Pre-intervention Period	Intervention Period Intervention Period Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff
Overall Study STARTED	503	395
Overall Study COMPLETED	327	287
Overall Study NOT COMPLETED	176	108

Reasons for withdrawal

Measure	Pre-intervention Period Pre-intervention Period	Intervention Period Intervention Period Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff
Overall Study Death	47	28
Overall Study Lost to Follow-up	75	57
Overall Study Withdrawal by Subject	54	23

Baseline Characteristics

Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

Baseline characteristics by cohort

Measure	Arm 1 n=503 Participants Pre-intervention Period	Arm 2 n=395 Participants Intervention Period Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff	Total n=898 Participants Total of all reporting groups
Age, Continuous	59.4 years STANDARD_DEVIATION 9.7 • n=93 Participants	58.8 years STANDARD_DEVIATION 10.2 • n=4 Participants	59.1 years STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	13 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	480 Participants n=93 Participants	382 Participants n=4 Participants	862 Participants n=27 Participants
Region of Enrollment United States	503 participants n=93 Participants	395 participants n=4 Participants	898 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months post enrollment

Population: This is the total number of subjects who completed 6 month follow-up (complete case analysis).

This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.

Outcome measures

Measure	Arm 1 n=498 Participants Pre-intervention Period	Arm 2 n=394 Participants Intervention Period Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff
7-day Point-prevalence Smoking Abstinence (6-month)	69 participants	53 participants

SECONDARY outcome

Timeframe: Assessed within 72 hours of hospital discharge

Outcome measures

Measure	Arm 1 n=498 Participants Pre-intervention Period	Arm 2 n=394 Participants Intervention Period Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff
Referrals to Quitline	0 participants	36 participants

SECONDARY outcome

Timeframe: Assessed within 72 hours of hospital discharge

Outcome measures

Measure	Arm 1 n=498 Participants Pre-intervention Period	Arm 2 n=394 Participants Intervention Period Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff
Prescription of Recommended Pharmacotherapy for Smoking Cessation	176 participants	149 participants

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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

David Katz, MD, MSc

Department of Veterans Affairs

Phone: 319-338-0581

Email: david-katz@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place