ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cigarette Smoking
Tobacco Smoking
Tobacco Use Disorder
Interventions: Behavioral: Sustained Care
Behavioral: Standard Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment of eligible daily smokers admitted to 3 hospitals (Massachusetts General Hospital, Boston, MA; University of Pittsburgh Medical Center, Pittsburgh, PA; and North Shore Medical Center, Salem, MA) occurred during the period 12/3/2012 - 7/18/2014

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1359 patients were enrolled in the study and randomized to Sustained Care (n=681) or Standard Care (n=678). Two patients, 1 in each group, were excluded post-randomization but before hospital discharge (when intervention began) because they were not eligible. ITT analysis was conducted on 1357 patients (Standard Care n=677, Sustained Care n=680).

Reporting Groups
  Description
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.

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.

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.

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.


Participant Flow:   Overall Study
    Standard Care   Sustained Care
STARTED   677   680 
COMPLETED   513   508 
NOT COMPLETED   164   172 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.

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.

Total Total of all reporting groups

Baseline Measures
   Standard Care   Sustained Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 677   680   1357 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.8  (12.4)   49.6  (12.8)   49.7  (12.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      336  49.6%      332  48.8%      668  49.2% 
Male      341  50.4%      348  51.2%      689  50.8% 
Region of Enrollment 
[Units: Participants]
     
United States   677   680   1357 


  Outcome Measures

1.  Primary:   Tobacco Abstinence - 6 Month Follow-up   [ Time Frame: 6 months ]

2.  Secondary:   Continuous Tobacco Abstinence   [ Time Frame: 1 month, 3 months, 6 months ]

3.  Secondary:   Point Prevalence Tobacco Abstinence   [ Time Frame: 1 month, 3 months, 6 months ]

4.  Secondary:   Duration of Tobacco Abstinence After Hospital Discharge   [ Time Frame: 1 month, 3 months, 6 months ]

5.  Secondary:   Use of Smoking Cessation Treatment After Hospital Discharge   [ Time Frame: 1 month, 3 months, 6 months ]

6.  Other Pre-specified:   All-cause Hospitalizations   [ Time Frame: 12 months ]

7.  Other Pre-specified:   All-cause Mortality   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nancy Rigotti, MD
Organization: Massachusetts General Hospital
phone: 617-724-4709
e-mail: nrigotti@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nancy A. Rigotti, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01714323     History of Changes
Other Study ID Numbers: 1R01HL111821 ( U.S. NIH Grant/Contract )
First Submitted: October 22, 2012
First Posted: October 25, 2012
Results First Submitted: November 23, 2016
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018