Personalized Tobacco Care Management
The multi-component Personalized Tobacco Care Management (PTCM) model builds on the Sustained Care model tested in our previous trials [
8‐
11,
28]. It aims to ensure that smoking cessation support and pharmacotherapy, the core components of effective tobacco dependence treatment [
5], are reliably delivered to participants following hospital discharge. Additionally, it can tailor the outreach to align with participants’ preferences for mode of contact (automated phone call, text message, or email).
Table 2
Operationalization of treatment components of the study interventions
Post-discharge outreach |
Modality | Phone call from state QL | Automated phone call or text message from IVR vendor |
Frequency | 1 call initiated after discharge to offer QL services | 7 calls made over 3 months after discharge (3 days; 2, 4, 6, 8, 10, 12 weeks) |
Free counseling |
Services offered | 5-call QL protocol (for 3 months) if participant enrolls in QL services | Up to 7 calls (over 3 months) |
When offered | At initial call from QL | On demand at each of 7 IVR calls |
Provider | QL-based tobacco coach | Hospital-based tobacco coach |
Free medication |
Type | Nicotine replacement: patch ± gum ± lozenge (varies by statea) | Nicotine replacement: patch, gum, lozenge, inhaler or combination |
Duration of treatment | 4–8 weeks (varies by stateb) | 8 weeks |
When provided | Mailed by QL after discharge if participant enrolls in QL services | Provided in hand at discharge |
Care coordination | NA | Tobacco coach interfaces with PCP via EHR notes at start and end of 3-month treatment and as needed for medication prescriptions in between |
EHR integration | Outbound: EHR referral link to QL; Inbound: varies by statec | Tobacco Coach notes and medication prescriptions are in EHR |
Patient choice | NA | Patient chooses mode of contact (IVR, text, email) & treatment (phone, text) |
To promote the use of cessation medication, PTCM provides study participants in hand at discharge a free 8-week supply of their choice of NRT patch, gum, or lozenge (alone or in combination). Our previous trials offered up to 3 months of any FDA-approved cessation medication (including bupropion or varenicline), with 1 month given at discharge and two refills provided on request. In the Helping HAND 2 trial, fewer than one-third of participants requested a medication refill after 1 month [
28]. Providing 8 weeks of medication in hand at discharge simplifies medication delivery, may promote a longer duration of medication use and provides the 8 weeks recommended by guidelines for a full treatment course [
4]. We narrowed the medication options for PTCM because NRT was the medication chosen by 95% of participants in the previous studies. Additionally, non-nicotine cessation medications require up to a week to become fully effective.
Post-discharge smoking cessation support and care coordination are conducted with an automated communication platform developed by TelASK Technologies (Ottawa, Canada) that contacts participants repeatedly in the post-discharge period and triages participants to additional counseling support. Using interactive voice response (IVR) technology, the system generates seven automated outbound phone calls at 3 days and 2, 4, 6, 8, 10, and 12 weeks after hospital discharge. Each call contains messages that promote medication adherence, support cessation efforts, and offer a return call from the hospital-based CTTS. Each automated call contact lasts 1 to 2 min. If the call fails to reach the participant, an email or text message with a link offering a return counseling call is sent, followed by another IVR call the next day. When a participant requests a return call, an attempt is made within 2 business days. At least three call attempts are made over 3 business days.
At each site, a CTTS performs the dual role of care coordinator and tobacco cessation counselor. As a coordinator, the CTTS interacts with the automated technology platform, responds to participants’ requests for return calls, and coordinates tobacco pharmacotherapy with the outpatient primary care team via EHR, fax, or email. In the counselor role, the CTTS provides brief (5–10 min) protocol-driven behavioral counseling and medication adherence support upon participant request. For example, when a participant has difficulty with the post-discharge medication, the CTTS may recommend switching the dose or contact the PCP via EHR notification or fax to request a prescription change. A detailed protocol for the phone counseling, based in motivational interviewing and cognitive-behavioral smoking cessation and relapse prevention techniques, was developed by study clinicians. The protocol also outlines medication management and adherence support, with the goal of supporting participants to complete a full course of cessation medication. Protocol modules address the following topics: choosing a medication, medication instructions and side effects, withdrawal symptoms, managing cravings, managing stress, relapse and making a new quit attempt, ambivalence, reducing negative self-talk, weight gain, rewards/self-care, and community resources.
At the end of the 12-week intervention, the study team sends a templated EHR note to the PCP to transfer care to the participant’s primary care team. The note reports the participant’s current smoking status, reviews the medication and counseling received in the past 3 months, and provides a future treatment recommendation. The recommendation includes advice to proactively contact the participant, a specific cessation medication recommendation, and advice to refer the participant to the state quitline for continued behavioral support.
Quitline eReferral
The control study arm actively refers a hospitalized participant to the state quitline for post-discharge care, incorporating a technologically advanced strategy that links hospital EHRs to state quitlines in a secure, HIPAA-compliant fashion. Previous studies found that referring hospitalized smokers to a quitline in a way not integrated in the EHR did not improve quit rates over usual care [
29,
30]. eReferral is a less intensive, lower cost option in which smokers receive a one-time automated referral from the EHR using a secure link to the state quitline at discharge. eReferral can be used by any EHR that is compliant with Meaningful Use Stage 2, and the eReferral model has demonstrated its feasibility to engage a clinical population of hospitalized smokers at all levels of readiness to quit smoking [
31,
32].
Care offered by the quitline includes behavioral support via phone counseling with a trained quitline coach and a course of free cessation medication. The number of counseling sessions offered (typically five over 3 months) and duration and type of medication (e.g., NRT for 2 to 8 weeks) are determined by each state’s quitline contract, which the state’s Department of Health negotiates with a quitline operator. In this study, two quitlines service eReferral participants. National Jewish Health (NJH) serves MA, PA, and VUMC participants residing in Kentucky. Information and Quality Healthcare (IQH) serves VUMC participants residing in Tennessee.
The study protocol planned for a bidirectional eReferral intervention at all sites; that is, a closed communication loop between the hospital and the quitline. Bidirectional eReferral follows the model of the North American Quitline Consortium formatting correction (NAQC) [
32]) in which feedback reports containing information on dispositional status (i.e., reached by the quitline), smoking status, medication use, and number of counseling calls used are returned directly to the participant’s medical record. For its feasibility, interoperability and efficiency, this bidirectional model has been endorsed by NAQC as a potential national standard of care [
32].
While approximately 25 state quitlines have adopted eReferral with at least one health care partner, substantial barriers to implementation of the full bidirectional model remain [
33]. A major barrier is closing the eReferral loop through successful delivery of the feedback report into the participant’s EHR. This step requires the healthcare system’s IT staff to create the interface engine to automatically process and file the incoming data. Bidirectional eReferral was accomplished at VUMC but could not be implemented at the other two sites for technical reasons. At those sites, unidirectional eReferrals were electronically made from the EHR to the quitline, which sends feedback reports to study staff only.
Assessments
Follow-up
Study participants are contacted 1, 3, and 6 months after discharge for follow-up assessments. Participants receive $20 for each completed survey. Surveys are sent by email or text if the participant consented to these contact methods. After five unsuccessful attempts, study staff call participants to administer the survey, making 24 attempts over 4 to 8 weeks. If unsuccessful, participants are mailed an abbreviated survey containing only the primary and secondary outcome measures.
Follow-up surveys assess participants’ use of cigarettes, e-cigarettes, and other tobacco products after discharge, including measures of duration of post-discharge abstinence and abstinence for the past 7 days and 30 days. Other measures include making a quit attempt (defined as intentional tobacco abstinence for > 24 h) and use of tobacco cessation treatments, including medications and behavioral support (telephone quit line, text-message support, in-person counseling, internet programs, or mobile phone applications). For each medication, duration and frequency of use and method of payment and attainment are assessed. Participants are also asked to report any hospital readmissions or emergency department visits since discharge. Baseline measures of alcohol and drug use, anxiety and depression symptoms, quality of life, and future expectations are re-assessed at follow-up. Table
3 displays the details and schedule of follow-up measures collected.
At the 1-month follow-up, participants are asked to report retrospectively how difficult it was to abstain from smoking in the hospital and whether they smoked during the inpatient stay. They are also asked if they recall receiving smoking cessation medications in hospital and/or at discharge, and to rate their satisfaction with smoking cessation assistance received in the hospital. At the 3-month follow-up (end of the active treatment period), participants are asked to rate their satisfaction with the resources provided by the study interventions.
At the 6-month survey, participants reporting tobacco abstinence in the past 7 days are asked to provide a saliva sample by mail for biochemical confirmation using an assay for cotinine, a nicotine metabolite (J2 Laboratories, Inc., Tucson, AZ, USA). Because NRT or electronic cigarette use produces a false positive cotinine result, biochemical validation for these participants requires an expired-air carbon monoxide (CO) measurement obtained at an in-person visit. Many participants who required CO verification were unable to make an in-person visit due to distance from the study sites. Consequently, the rate at which participants submitted a biochemical sample for verification was much lower for CO than for cotinine. To address this problem, we added a home-based option for CO verification in November 2019. We offer to mail participants a personalized CO device (iCO Smokerlyzer, CoVita) to complete the CO reading remotely. Participants download a free app to record CO readings that are automatically emailed to the study staff. Participants were initially provided a $50 honorarium, not contingent on test results, upon receipt of the saliva sample or completion of the CO measurement. The return rate of samples, especially CO samples, was lower than anticipated, and the honorarium was increased to $150 in January 2020.
Semi-structured qualitative telephone interviews are conducted after the final outcome assessment, using a purposive sample of participants representing both study arms and smoking outcomes. The goal is to understand in greater detail participants’ experience with the interventions and with attempting to abstain from tobacco products after discharge. Interviews are recorded, transcribed, and thematically analyzed using NVivo 12 qualitative data analysis software (QSR International Pty Ltd, version 12, 2018).