The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol

Abstract

Background: Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group).

Methods: The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates) and patient participation (proportion referred who go to the website). We will then compare the effectiveness of the standard and augmented patient websites.

Discussion: Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login) and patient outcomes (six-month smoking cessation).

Trial registration: Web-delivered Provider Intervention for Tobacco Control (QUIT-PRIMO) - a randomized controlled trial: NCT00797628.

Figure 1

Major components* of QUIT-PRIMO provider-patient informatics intervention. * All components are supported by repeated, targeted email reminders designed to prompt participation and cue increased smoking cessation. Emails will invite enrolled smokers, provide motivational and educational messages to enrolled smokers, notify providers of new web reports, and alert providers to new messages from patients. A proactive Help Desk will also be available as part of the intervention.

Figure 2

Enrollment and randomization strategy.

Figure 3

How the integrated QUIT-PRIMO is conceptualized to improve processes of care (5 As) and increase smoking cessation: use of the clinical microsystem intervention over time by one example practice and one patient. A1: Ask--ReferaSmoker sends email prompts to providers reminding them of the importance of smoking cessation; provider downloads printable chart stickers, etc., to increase systematic screening by nurses. A2: Advise--ReferaSmoker materials provide additional knowledge to providers on strong advice; provider advises patient. A3: Assess--Provider explains content of Decide2Quit and assesses willingness of patient to use system and to quit. A4: Assist--Patient agrees to be recruited and nurse enters patient email into ReferaSmoker online portal and patient is enrolled into the system. Decide2Quit sends email reminders to the patient. Patient uses system and talks to family because of the motivational messages. A4: Assist--Patient engages in the online support group, shares his quitting experiences and finds others with similar experiences, posts a question online, and interacts with other smokers trying to quit. A4: Assist--Patient selects a tobacco treatment specialist (TTS) and posts a question to her using the MyMail feature of the system. The TTS responds with helpful suggestions, and the patient returns to the system to read her responses. A4: Assist--Patient continuously receives tailored "advice" emails from the system. Emails are from experts and peers. A5: Arrange--Nurse (and/or physician) reviews reports of patient use and follows up. Nurse sends a template-driven email message encouraging use of the system and offering treatment. A4: (more) Assist--Patient returns to Decide2Quit repeatedly, is increasingly motivated, requests treatments → quits.