View Clinical Trial (Medical Research Study)
Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial
| City: |
|
Boston |
| State: |
|
Massachusetts |
| Zip Code: |
|
02114 |
| Conditions: |
|
Cigarette Smoking |
| Purpose: |
|
Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million
U.S. smokers are hospitalized each year, many of them at high risk for tobacco-related
disease or death. A hospital admission provides an opportunity for a smoker to quit.
Smoking cessation counseling provided in the hospital is effective, but only if it continues
for >1 month after discharge. Smoking cessation medications add benefit to counseling but
are not often used. The challenge is to translate this efficacy research into routine
clinical practice. The major barrier is to make the transition from inpatient to outpatient
care. An evidence-based, cost-effective intervention model that can be adopted by U.S.
hospitals is needed to realize the potential impact of hospital smoking interventions.
The Specific Aim of this project is to conduct a randomized controlled comparative
effectiveness trial of two strategies to promote smoking cessation in hospitalized patients:
(1) a hospital-only intervention that meets the current standard of the National Hospital
Quality Measures("Standard Care"), and (2) an "Extended Care Management" model with 2
components that aims to encourage and facilitate the sustained use of smoking cessation
treatment (counseling and medication use) after discharge in order to achieve long-term
abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge
and feature 2 innovations: (1) to increase medication use, smokers willing to make a quit
attempt receive a free, refillable 30-day sample of their choice of FDA-approved smoking
cessation medication at hospital discharge; (2) to increase counseling cost-effectiveness,
interactive voice recognition (IVR) technology is used to make automated telephone calls to
identify the smokers interested in or most likely to benefit from continued counseling after
discharge. The trial will enroll 330 adult smokers admitted to Massachusetts General
Hospital, a 900-bed teaching hospital. Outcomes will be measured 1,3 and 6 months after
hospital discharge. Study hypotheses are that the enhanced care arm, compared to usual care,
is feasible and will increase (1) the use of smoking cessation treatment after discharge,
(2) the duration of post-discharge tobacco abstinence, and (3) validated tobacco abstinence
6 months after hospital discharge (primary outcome). The principal secondary outcome
measure is self-reported 7-day point prevalence tobacco abstinence after hospital discharge.
Other secondary endpoints include self-reported point prevalence abstinence at 1 and 3
months, prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The
cost-effectiveness (cost per quit) of the interventions will be also be compared.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Cigarette smoker (daily smoker when smoking in usual way during the month before
hospital admission)
- Counseled by hospital smoking counselor during hospital stay
- Plans to stop smoking tobacco products after hospital discharge
- Appropriate for use of smoking cessation medication after discharge
Exclusion Criteria:
- Expected hospital length of stay <24 hours
- Not expected to be discharged to home
- No access to a telephone
- Unable to communicate by telephone
- Severe psychiatric or neurologic disease precluding ability to be counseled
- Pregnant, nursing, or planning to become pregnant in next 3 months
- Active substance abuse other than tobacco
- Unable to speak English
|
| NCT ID: |
|
NCT01177176 |
| Primary Contact: |
|
Principal Investigator
Nancy A Rigotti, MD
Massachusetts General Hospital
Nancy A Rigotti, MD
Phone: 617-724-4709
Email: nrigotti@partners.org
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Boston, Massachusetts 02114
United States
Nancy A Rigotti, MD
Phone: 617-724-4709
Email: nrigotti@partners.org
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|