Cigarette Smoking
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point-prevalence Smoking Abstinence (6-month) | 6 months post enrollment | This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview. |
Secondary
| Measure | Time frame |
|---|---|
| Referrals to Quitline | Assessed within 72 hours of hospital discharge |
| Prescription of Recommended Pharmacotherapy for Smoking Cessation | Assessed within 72 hours of hospital discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 898 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 47 | 28 |
| Overall Study | Lost to Follow-up | 75 | 57 |
| Overall Study | Withdrawal by Subject | 54 | 23 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 59.4 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 participants | 395 participants | 898 participants |
| Sex: Female, Male Female | 23 Participants | 13 Participants | 36 Participants |
| Sex: Female, Male Male | 480 Participants | 382 Participants | 862 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 503 | 0 / 395 |
| serious Total, serious adverse events | 0 / 503 | 0 / 395 |
Outcome results
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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | 7-day Point-prevalence Smoking Abstinence (6-month) | 69 participants |
| Arm 2 | 7-day Point-prevalence Smoking Abstinence (6-month) | 53 participants |
Prescription of Recommended Pharmacotherapy for Smoking Cessation
Time frame: Assessed within 72 hours of hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Prescription of Recommended Pharmacotherapy for Smoking Cessation | 176 participants |
| Arm 2 | Prescription of Recommended Pharmacotherapy for Smoking Cessation | 149 participants |
Referrals to Quitline
Time frame: Assessed within 72 hours of hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Referrals to Quitline | 0 participants |
| Arm 2 | Referrals to Quitline | 36 participants |