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

• 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: Massachusetts General Hospital
• Collaborators: University of Pittsburgh; North Shore Medical Center
• Information provided by (Responsible Party): Nancy A. Rigotti, Massachusetts General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking; Tobacco Smoking; Tobacco Use Disorder	Behavioral: Sustained Care; Behavioral: Standard Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1359 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
• Study Start Date: December 2012
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Tobacco Abstinence - 6 Month Follow-up [ Time Frame: 6 months ]
   Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up

Secondary Outcome Measures :

1. 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.
2. 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
3. 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.
4. 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).

Other Outcome Measures:

1. All-cause Hospitalizations [ Time Frame: 12 months ]
   Self-reported admission to a hospital in the 12 months after the index hospitalization.
2. All-cause Mortality [ Time Frame: 6 months ]
   Death from any cause in the 6 months after hospital discharge

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

North Shore Medical Center

Salem, Massachusetts, United States, 01970

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

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

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

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.

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

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nancy A. Rigotti, Massachusetts General Hospital:

Cigarette smoking; Tobacco smoking; Tobacco use disorder

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders