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Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2)

This study is not yet open for participant recruitment.
Verified October 2012 by Massachusetts General Hospital
Sponsor:
Collaborators:
University of Pittsburgh
North Shore Medical Center
Information provided by (Responsible Party):
Nancy A. Rigotti, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01714323
First received: October 22, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking
Tobacco Smoking
Tobacco Use Disorder
 Behavioral: Extended Care
Behavioral: Standard Care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Tobacco Abstinence - 6 month follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up


Secondary Outcome Measures:
  • Continuous tobacco abstinence [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    Continuous tobacco abstinence after hospital discharge assessed by self-report

  • Point prevalence tobacco abstinence [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report

  • Duration of tobacco abstinence after hospital discharge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report

  • Use of smoking cessation treatment after hospital discharge [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    Use of (1) FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), (2) psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling), and (3) either of above since hospital discharge.

  • Sustained tobacco abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self-reported 7-day point prevalence tobacco abstinence at 1 and 3 and 6 months after discharge


Other Outcome Measures:
  • All-cause hospitalizations [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Self-reported admission to a hospital in the 6 and 12 months after the index hospitalization. Will be assessed as both a dichotomous variable (yes/no) and continuous (number of hospitalizations).

  • All-cause mortality [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Death from any cause in the 6 and 12 months after hospital discharge

  • Cost-effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Incremental cost per quit of Extended Care over Standard Care


Estimated Enrollment: 1350
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard care
At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
 Behavioral: Standard Care
Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
Experimental: Extended Care
A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.
 Behavioral: Extended Care
A 3-month program after hospital discharge with these 2 components: (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 (Alere Wellbeing, Inc., previously Free & Clear). 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714323

Contacts
Contact: Jennifer Kulesa-Kelley, RN 781-433-3041 jkelley4@partners.org
Contact: Nancy A Rigotti, MD 617 724 3548 nrigotti@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jennifer Kulesa-Kelley, RN     781-433-3041     jkelley4@partners.org    
Principal Investigator: Nancy Rigotti, MD            
North Shore Medical Center Not yet recruiting
Salem, Massachusetts, United States, 01970
Contact: Kelly Lombardo     978-354-2348     KLOMBARDO@PARTNERS.ORG    
Principal Investigator: Faysal Hasan, MD            
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Hilary Tindle, MD, MPH     412-246-6929     tindleha@upmc.edu    
Principal Investigator: Hilary Tindle, MD, MPH            
Sponsors and Collaborators
Massachusetts General Hospital
University of Pittsburgh
North Shore Medical Center
Investigators
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Nancy A. Rigotti, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01714323     History of Changes
Other Study ID Numbers: 1 R01 HL111821
Study First Received: October 22, 2012
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Cigarette smoking
Tobacco smoking
Tobacco use disorder

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013