Clinical trial NCT01714323: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Official title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Tobacco Smoking
Tobacco Use Disorder
Keywords: Cigarette smoking
Tobacco smoking
Tobacco use disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: North Shore Medical Center
First posted: 2012-10-25
Enrollment: 1359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Tobacco Abstinence - 6 Month Follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Continuous Tobacco Abstinence
timeFrame: 1 month, 3 months, 6 months
measure: Point Prevalence Tobacco Abstinence
timeFrame: 1 month, 3 months, 6 months
measure: Duration of Tobacco Abstinence After Hospital Discharge
timeFrame: 1 month, 3 months, 6 months
measure: Use of Smoking Cessation Treatment After Hospital Discharge
timeFrame: 1 month, 3 months, 6 months
Other outcomes:
measure: All-cause Hospitalizations
timeFrame: 12 months
measure: All-cause Mortality
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Salem
country: United States
facility: North Shore Medical Center
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.