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

Abstract

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.

Comparative Effectiveness of Postdischarge Smoking Cessation Interventions for Hospital Patients

“…The TTCM health care system–based multicomponent intervention was adapted from our previous model . At discharge, participants received a free 8-week supply of their choice of NRT patch, gum, or lozenge (alone or in combination).…”

“…Each state’s contract with the quitline operator determined how many counseling sessions (typically 5 over 3 months) and weeks of NRT sample were offered. The study protocol stipulated bidirectional electronic referral to allow quitline reports of the referral outcome to return to the participant’s EHR. However, technological barriers allowed only unidirectional electronic referral at Massachusetts General Hospital and University of Pittsburgh Medical Center.…”

“…A sample of 1350 participants (675 participants per group) was planned to detect a 6.5% difference (23.0% vs 16.5%) in the primary outcome measure with 84% power and a 2-sided P < .05. Analyses used an intention-to-treat approach. Data from the 3 sites were combined for analysis after Cochran-Mantel-Haenzel tests confirmed that intervention effects were not heterogeneous across sites.…”

“…Institutional review boards at each hospital approved the study, and all participants provided oral informed consent. A detailed study protocol is available in Supplement 1 and has been published elsewhere …”

“…Quitline staff called the participant to offer telephone counseling calls from a trained coach and a free NRT sample to eligible callers. Each state’s contract with the quitline operator determined how many counseling sessions (typically 5 over 3 months) and weeks of NRT sample were offered . The study protocol stipulated bidirectional electronic referral to allow quitline reports of the referral outcome to return to the participant’s EHR.…”