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N/A N=1,357 Randomized Treatment

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Cigarette Smoking · Tobacco Smoking · Tobacco Use Disorder

Enrolled (actual)
1,357
Serious AEs
32.4%
Results posted
Jun 2018
Primary outcome: Primary: Tobacco Abstinence - 6 Month Follow-up — 105; 113 Participants — p=>0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Sustained Care (Behavioral); Standard Care (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Oct 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Tobacco Abstinence - 6 Month Follow-up
105; 113 >0.05
SECONDARY
Continuous Tobacco Abstinence
179; 211; 122; 147; 101; 121 >0.05
SECONDARY
Point Prevalence Tobacco Abstinence
217; 295; 206; 253; 180; 209 <0.001 sig
SECONDARY
Duration of Tobacco Abstinence After Hospital Discharge
7; 14
SECONDARY
Use of Smoking Cessation Treatment After Hospital Discharge
306; 491; 404; 554; 448; 580 <0.001 sig

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01714323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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