Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial.

Autor: Rigotti NA; Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA. nrigotti@partners.org.; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA. nrigotti@partners.org.; Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston, MA, USA. nrigotti@partners.org.; Harvard Medical School, Boston, MA, USA. nrigotti@partners.org., Schnitzer K; Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.; Harvard Medical School, Boston, MA, USA.; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA., Davis EM; University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; University of Pittsburgh Medical Center, Pittsburgh, PA, USA., Regan S; Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA., Chang Y; Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA., Kelley JHK; Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.; Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston, MA, USA., Notier AE; University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; University of Pittsburgh Medical Center, Pittsburgh, PA, USA., Gilliam K; Vanderbilt University Medical Center, Nashville, TN, USA., Douaihy A; University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; University of Pittsburgh Medical Center, Pittsburgh, PA, USA., Levy DE; Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.; Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA., Singer DE; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA., Tindle HA; Vanderbilt University Medical Center, Nashville, TN, USA.; Geriatric Research Education and Clinical Centers (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, TN, USA.
Jazyk: angličtina
Zdroj: Trials [Trials] 2020 Apr 16; Vol. 21 (1), pp. 336. Date of Electronic Publication: 2020 Apr 16.
DOI: 10.1186/s13063-020-04257-7
Abstrakt: Background: Tobacco smoking remains the leading preventable cause of death in the US. A hospital admission provides smokers with a unique opportunity to stop smoking because it requires temporary tobacco abstinence while illness may enhance motivation to quit. Hospital interventions must continue post-discharge to increase tobacco abstinence long-term, but how best to accomplish this remains unclear. Building on two previous randomized controlled trials, each of which tested smoking cessation interventions that began in hospital and continued after discharge, this trial compares two interventions that provide sustained smoking cessation treatment after hospital discharge with the goal of improving long-term smoking cessation rates among hospitalized smokers.
Methods/design: Helping HAND 4 is a three-site randomized controlled trial that compares the effectiveness of two active interventions for producing validated past 7-day tobacco abstinence 6 months after hospital discharge. Smokers who are admitted to three hospitals receive a standard in-hospital smoking intervention, and those who plan to quit smoking after discharge are recruited and randomly assigned to two interventions that begin at discharge, Personalized Tobacco Care Management (PTCM) or Quitline eReferral. Each lasts 3 months. At discharge, PTCM provides 8 weeks of free nicotine replacement (NRT; a participant's choice of patch, gum, lozenge, or a combination) and then proactive smoking cessation support using an automated communication platform and live contact with a tobacco treatment specialist who is based in the health care system. In the eReferral condition, a direct referral is made from the hospital electronic health record to a community-based resource, the state's telephone quitline. The quitline provides up to 8 weeks of free NRT and offers behavioral support via a series of phone calls from a trained coach. Outcomes are assessed at 1, 3, and 6 months after discharge. The study hypothesis is that PTCM will produce higher quit rates than eReferral.
Discussion: Helping HAND 4 is a pragmatic trial that aims to evaluate interventions in real-world conditions. This project will give hospital systems critical evidence-based tools for meeting National Hospital Quality Measures for tobacco treatment and maximizing their ability to improve cessation rates and overall health for the millions of smokers hospitalized annually in the US.
Trial Registration: Prospectively registered prior to start of enrollment at Clinicaltrials.gov, NCT03603496 (July 27, 2018). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00084MJ&selectaction=Edit&uid=U00002G7&ts=2&cx=ff0oxn.
Databáze: MEDLINE
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