Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Tobacco Use Disorder Clinical Trial

— Helping HAND2  

Official title:

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714323
• Other study ID #: 1R01HL111821
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1359
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	North Shore Medical Center	Salem	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	North Shore Medical Center, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause Hospitalizations	Self-reported admission to a hospital in the 12 months after the index hospitalization.	12 months
Other	All-cause Mortality	Death from any cause in the 6 months after hospital discharge	6 months
Primary	Tobacco Abstinence - 6 Month Follow-up	Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up	6 months
Secondary	Continuous Tobacco Abstinence	Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.	1 month, 3 months, 6 months
Secondary	Point Prevalence Tobacco Abstinence	7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report	1 month, 3 months, 6 months
Secondary	Duration of Tobacco Abstinence After Hospital Discharge	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.	1 month, 3 months, 6 months
Secondary	Use of Smoking Cessation Treatment After Hospital Discharge	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).	1 month, 3 months, 6 months