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

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ClinicalTrials.gov Identifier: NCT01714323
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
University of Pittsburgh
North Shore Medical Center
Information provided by (Responsible Party):
Nancy A. Rigotti, Massachusetts General Hospital

October 22, 2012
October 25, 2012
November 23, 2016
June 8, 2018
June 8, 2018
December 2012
October 2016   (Final data collection date for primary outcome measure)
Tobacco Abstinence - 6 Month Follow-up [ Time Frame: 6 months ]
Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up
Same as current
Complete list of historical versions of study NCT01714323 on ClinicalTrials.gov Archive Site
  • Continuous Tobacco Abstinence [ Time Frame: 1 month, 3 months, 6 months ]
    Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.
  • Point Prevalence Tobacco Abstinence [ Time Frame: 1 month, 3 months, 6 months ]
    7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
  • Duration of Tobacco Abstinence After Hospital Discharge [ Time Frame: 1 month, 3 months, 6 months ]
    Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.
  • Use of Smoking Cessation Treatment After Hospital Discharge [ Time Frame: 1 month, 3 months, 6 months ]
    Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).
  • Continuous Tobacco Abstinence [ Time Frame: 1 month, 3 months, 6 months ]
    Continuous tobacco abstinence after hospital discharge assessed by self-report
  • Point Prevalence Tobacco Abstinence [ Time Frame: 1 month, 3 months, 6 months ]
    7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
  • Duration of Tobacco Abstinence After Hospital Discharge [ Time Frame: 6 months ]
    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 ]
    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 ]
    Self-reported 7-day point prevalence tobacco abstinence at 1 and 3 and 6 months after discharge
  • All-cause Hospitalizations [ Time Frame: 12 months ]
    Self-reported admission to a hospital in the 12 months after the index hospitalization.
  • All-cause Mortality [ Time Frame: 6 months ]
    Death from any cause in the 6 months after hospital discharge
  • All-cause Hospitalizations [ Time Frame: 6 months, 12 months ]
    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 ]
    Death from any cause in the 6 and 12 months after hospital discharge
  • Cost-effectiveness [ Time Frame: 6 months ]
    Incremental cost per quit of Extended Care over Standard Care
 
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cigarette Smoking
  • Tobacco Smoking
  • Tobacco Use Disorder
  • Behavioral: Sustained 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.
  • 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.
  • 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.
    Intervention: Behavioral: Standard Care
  • Experimental: Sustained 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.
    Intervention: Behavioral: Sustained Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1359
1350
October 2016
October 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01714323
1R01HL111821( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Nancy A. Rigotti, Massachusetts General Hospital
Massachusetts General Hospital
  • University of Pittsburgh
  • North Shore Medical Center
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Massachusetts General Hospital
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP