Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway.

Background Oral anticoagulation reduces stroke and disability in atrial fibrillation (AF) but is underused. We evaluated the effects of a novel patient-clinician shared decision-making (SDM) tool in reducing oral anticoagulation patient's decisional conflict as compared with usual care. Methods and Results We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE-AF (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention). The digital AF shared decision-making toolkit was developed using patient-centered design with clear health communication principles (eg, meaningful images, limited text). Available in English and Spanish, the toolkit included the following: (1) a brief animated video; (2) interactive questions with answers; (3) a quiz to check on understanding; (4) a worksheet to be used by the patient during the encounter; and (5) an online guide for clinicians. The study population included English or Spanish speakers with nonvalvular AF and a CHA2DS2-VASc stroke score ≥1 for men or ≥2 for women. Participants were randomized in a 1:1 ratio to either usual care or the shared decision-making toolkit. The primary end point was the validated 16-item Decision Conflict Scale at 1 month. Secondary outcomes included Decision Conflict Scale at 6 months and the 10-item Decision Regret Scale at 1 and 6 months as well as a weighted average of Mann-Whitney U-statistics for both the Decision Conflict Scale and the Decision Regret Scale. A total of 1001 participants were enrolled and followed at 5 different sites in the United States between December 18, 2019, and August 17, 2022. The mean patient age was 69±10 years (40% women, 16.9% Black, 4.5% Hispanic, 3.6% Asian), and 50% of participants had CHA2DS2-VASc scores ≥3 (men) or ≥4 (women). The primary end point at 1 month showed a clinically meaningful reduction in decisional conflict: a 7-point difference in median scores between the 2 arms (16.4 versus 9.4; Mann-Whitney U-statistics=0.550; P=0.007). For the secondary end point of 1-month Decision Regret Scale, the difference in median scores between arms was 5 points in the direction of less decisional regret (P=0.078). The treatment effects lessened over time: at 6 months the difference in medians was 4.7 points for Decision Conflict Scale (P=0.060) and 0 points for Decision Regret Scale (P=0.35). Conclusions Implementation of a novel shared decision-making toolkit (afibguide.com; afibguide.com/clinician) achieved significantly lower decisional conflict compared with usual care in patients with AF. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04096781.

Impact of Medical Marijuana Laws on State-Level Marijuana Use by Age and Gender, 2004-2013.

In states that have passed medical marijuana laws (MMLs), marijuana use (MU) increased after MML enactment among people ages 26 and older, but not among ages 12-25. We examined whether the age-specific impact of MMLs on MU varied by gender. Data were obtained from the 2004-2013 restricted-use National Survey on Drug Use and Health, aggregated at the state level. The exposure was a time-varying indicator of state-level MML (0 = No Law, 1 = Before Law, 2 = After Law). Outcomes included past-month MU prevalence, daily MU prevalence among past-year users (i.e., 300+ days/year), and past-year marijuana use disorder (MUD) prevalence. Linear models tested the state-level MML effect on outcomes by age (12-17, 18-25, 26+) and gender. Models included a state-level random intercept and controlled for time- and state-level covariates. Past-month MU did not increase after enactment of MML in men or women ages 12-25. Among people 26+, past-month MU increased for men from 7.0% before to 8.7% after enactment (+ 1.7%, p < 0.001) and for women from 3.1% before to 4.3% after enactment (+ 1.1%, p = 0.013). Among users 26+, daily MU also increased after enactment in both genders (men 16.3 to 19.1%, + 2.8%, p = 0.014; women 9.2 to 12.7%, + 3.4%, p = 0.003). There were no statistically significant increases in past-year MUD prevalence for any age or gender group after MML enactment. Given the statistically significant increase in daily use among past-year users aged 26+ following enactment, education campaigns should focus on informing the public of the risks associated with regular marijuana use.