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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking; Tobacco Use Disorder; Cigarette Smoking
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: Sustained Care

• Study Type: Interventional
• Enrollment (Actual): 1359
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Salem, Massachusetts, United States, 01970
      • North Shore Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Abstinence - 6 Month Follow-up	Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Point Prevalence Tobacco Abstinence	7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report	1 month, 3 months, 6 months
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Hospitalizations	Self-reported admission to a hospital in the 12 months after the index hospitalization.	12 months
All-cause Mortality	Death from any cause in the 6 months after hospital discharge	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: University of Pittsburgh; North Shore Medical Center

Publications and helpful links

General Publications

• Triant VA, Grossman E, Rigotti NA, Ramachandran R, Regan S, Sherman SE, Richter KP, Tindle HA, Harrington KF. Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. Nicotine Tob Res. 2020 Jun 12;22(7):1170-1177. doi: 10.1093/ntr/ntz168.
• Streck JM, Chang Y, Tindle HA, Regan S, Park ER, Levy DE, Singer DE, Ylioja T, Rigotti NA. Smoking Cessation After Hospital Discharge: Factors Associated With Abstinence. J Hosp Med. 2018 Nov 1;13(11):774-778. doi: 10.12788/jhm.2997. Epub 2018 Aug 29.
• Rigotti NA, Chang Y, Tindle HA, Kalkhoran SM, Levy DE, Regan S, Kelley JHK, Davis EM, Singer DE. Association of E-Cigarette Use With Smoking Cessation Among Smokers Who Plan to Quit After a Hospitalization: A Prospective Study. Ann Intern Med. 2018 May 1;168(9):613-620. doi: 10.7326/M17-2048. Epub 2018 Mar 27.
• Rigotti NA, Chang Y, Rosenfeld LC, Japuntich SJ, Park ER, Tindle HA, Levy DE, Reid ZZ, Streck J, Gomperts T, Kelley JHK, Singer DE. Interactive Voice Response Calls to Promote Smoking Cessation after Hospital Discharge: Pooled Analysis of Two Randomized Clinical Trials. J Gen Intern Med. 2017 Sep;32(9):1005-1013. doi: 10.1007/s11606-017-4085-z. Epub 2017 Jun 14.
• Rigotti NA, Tindle HA, Regan S, Levy DE, Chang Y, Carpenter KM, Park ER, Kelley JH, Streck JM, Reid ZZ, Ylioja T, Reyen M, Singer DE. A Post-Discharge Smoking-Cessation Intervention for Hospital Patients: Helping Hand 2 Randomized Clinical Trial. Am J Prev Med. 2016 Oct;51(4):597-608. doi: 10.1016/j.amepre.2016.04.005.
• Reid ZZ, Regan S, Kelley JH, Streck JM, Ylioja T, Tindle HA, Chang Y, Levy DE, Park ER, Singer DE, Carpenter KM, Reyen M, Rigotti NA. Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers: study protocol for the Helping HAND 2 randomized controlled trial. BMC Public Health. 2015 Feb 7;15:109. doi: 10.1186/s12889-015-1484-0.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Cigarette smoking; Tobacco use disorder; Tobacco smoking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 1R01HL111821 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No