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Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00816036
Enrollment
898
Registered
2008-12-31
Start date
2009-05-31
Completion date
2013-08-31
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

Keywords

Smoking Cessation, Practice Guidelines, Inpatient, Effectiveness Trial, Veterans Administration, Relapse prevention

Brief summary

The primary objective of this study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. If proven effective, the proposed intervention will provide a practical strategy to enhance the adoption and implementation of recommended smoking cessation procedures in VA hospitals, and will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once they leave the hospital.

Detailed description

Although the majority of hospitalized VA smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation. The primary objective of this research study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. Co-primary aims are to determine whether the intervention improves the prescription of recommended pharmacotherapy for smoking cessation and the referral of patients for telephone counseling (or other outpatient cessation counseling). We will perform a quasi-experimental before-after trial in hospitalized patients, aged 18 or older, who smoke at least one cigarette per day on average. After a 6-month baseline period, we will implement the intervention and enroll a separate cohort of patients over the subsequent 6 months. The intervention will include: 1) nurse training in delivery of bedside cessation counseling, 2) use of CPRS-based practice tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy), 3) computerized referral of motivated inpatients for proactive telephone counseling, and 4) use of nursing peer leaders to provide coaching and performance feedback to ward nurses. Enrolled patients will be contacted by telephone at 3 and 6 months to assess 7-day point prevalence abstinence and prolonged abstinence (with biochemical confirmation of self-reported quitters at 6 months). We will identify barriers and facilitators to implementation by using clinician focus groups, and will assess attitudes of staff nurses toward cessation counseling by questionnaire. We will also conduct semi-structured interviews in a subsample of patients and nurses to assess perceptions of the intervention, and will use content analysis to interpret the data.

Interventions

1\. Enhanced academic detailing of staff nurses (face-to-face training, feedback on group performance, and periodic check-ins with both nurse managers and peer leaders); 2. Adaptation of the computerized information system (modified nursing admission database that includes pertinent questions about smoking, computerized quick orders for smoking cessation medications), 3) Patient self-management support (self-help materials, fax referral of motivated patients to state quit line), and 4) nursing peer leaders on each study unit.

Sponsors

National Jewish Hospital Quitline
CollaboratorUNKNOWN
Iowa State University
CollaboratorOTHER
US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients: The study sample will include general medical inpatients, aged 18 or older, who smoke at least one cigarette per day on average, regardless of their willingness to quit smoking. To increase applicability of study results, the goal is to enroll patients with characteristics that reflect the full range and distribution of patients observed in clinical practice. Current smokers transferred from intensive care units (or other monitored beds) to a general medical ward will be eligible. * Nurses: The study sample will include staff nurses who are assigned to a general medicine inpatient unit at one of the participating sites.

Exclusion criteria

* Hospitalization for less than 18 hours (e.g., patients admitted for overnight observation); * Acute medical decomposition (e.g., acute respiratory failure requiring intubation, cardiac arrest, septic shock); * Altered mental status; * Unstable psychiatric disorder (e.g., acute psychosis); * Dementia; * Communication barrier (unable to speak English, hard of hearing, aphasic); * Pregnancy; * Terminal illness (\<12 month life expectancy); * No access to a phone or the absence of a permanent address; * Admitted for treatment of substance abuse. No patient will be included unless they are able to provide informed consent and agree to be contacted by telephone during follow-up (to assess smoking status).

Design outcomes

Primary

MeasureTime frameDescription
7-day Point-prevalence Smoking Abstinence (6-month)6 months post enrollmentThis is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.

Secondary

MeasureTime frame
Referrals to QuitlineAssessed within 72 hours of hospital discharge
Prescription of Recommended Pharmacotherapy for Smoking CessationAssessed within 72 hours of hospital discharge

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Pre-intervention Period
503
Arm 2
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
395
Total898

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath4728
Overall StudyLost to Follow-up7557
Overall StudyWithdrawal by Subject5423

Baseline characteristics

CharacteristicArm 1Arm 2Total
Age, Continuous59.4 years
STANDARD_DEVIATION 9.7
58.8 years
STANDARD_DEVIATION 10.2
59.1 years
STANDARD_DEVIATION 9.9
Region of Enrollment
United States
503 participants395 participants898 participants
Sex: Female, Male
Female
23 Participants13 Participants36 Participants
Sex: Female, Male
Male
480 Participants382 Participants862 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 5030 / 395
serious
Total, serious adverse events
0 / 5030 / 395

Outcome results

Primary

7-day Point-prevalence Smoking Abstinence (6-month)

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

Time frame: 6 months post enrollment

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

ArmMeasureValue (NUMBER)
Arm 17-day Point-prevalence Smoking Abstinence (6-month)69 participants
Arm 27-day Point-prevalence Smoking Abstinence (6-month)53 participants
Secondary

Prescription of Recommended Pharmacotherapy for Smoking Cessation

Time frame: Assessed within 72 hours of hospital discharge

ArmMeasureValue (NUMBER)
Arm 1Prescription of Recommended Pharmacotherapy for Smoking Cessation176 participants
Arm 2Prescription of Recommended Pharmacotherapy for Smoking Cessation149 participants
Secondary

Referrals to Quitline

Time frame: Assessed within 72 hours of hospital discharge

ArmMeasureValue (NUMBER)
Arm 1Referrals to Quitline0 participants
Arm 2Referrals to Quitline36 participants

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026