Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers



Status:Completed
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:6/10/2018
Start Date:December 2012
End Date:October 2016

Use our guide to learn which trials are right for you!

Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public
Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers
in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized
each year, and hospital admission offers a "teachable moment" for intervention.
Hospital-initiated smoking cessation intervention is effective, but only if contact continues
for more than 1 month after discharge. The challenge is to translate this research into
clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals
can adopt. The major barrier is sustaining contact after discharge. This project tests an
innovative strategy to streamline the delivery and maximize the uptake of post-discharge
smoking interventions.

Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of
evidence-based tobacco treatment (counseling and medication) after hospital discharge,
thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco
abstinence.

Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll
1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All
subjects will receive a brief in-hospital smoking intervention and be randomly assigned at
discharge to either Standard Care (passive referral to their state quitline) or Extended
Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved
medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and
refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive
Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR
aims to encourage medication adherence and enhance counseling efficiency by identifying
smokers who need post-discharge support. Immediate transfer of a patient from automated IVR
call to live telephone counselor will facilitate a successful connection to counseling.

Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention
effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month
follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment
utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine
the intervention's effect on hospital readmissions and mortality in the 6 months after
discharge.


Inclusion Criteria:

- Cigarette smoker (smoked at least 1 cigarette in the month before hospital admission
and at least 1 cigarette per day when smoking at baseline rate in the month before
hospital admission)

- Counseled by hospital smoking counselor during hospital stay

- Plans to stop smoking tobacco products after hospital discharge

- Agrees to take home a supply of smoking cessation medication after discharge

- Agrees to and able to accept telephone calls after hospital discharge

Exclusion Criteria:

- No access to a telephone or unable to communicate by telephone

- Severe psychiatric or neurologic disease precluding ability to provide informed
consent and to be counseled

- Pregnant, nursing, or planning to become pregnant in next 3 months

- Unable to speak English

- Medical instability precluding study participation
We found this trial at
3
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Salem, Massachusetts 01970
?
mi
from
Salem, MA
Click here to add this to my saved trials