The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design.

INTRODUCTION: Shared decision making (SDM) may result in treatment plans that best reflect the goals and wishes of patients, increasing patient satisfaction with the decision-making process. There is a knowledge gap to support the use of decision aids in SDM for anticoagulation therapy in patients with atrial fibrillation (AF). We describe the development and testing of a new decision aid, including a multicenter, randomized, controlled, 2-arm, open-label ENHANCE-AF clinical trial (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention) to evaluate its effectiveness in 1,200 participants. METHODS: Participants will be randomized to either usual care or to a SDM pathway incorporating a digital tool designed to simplify the complex concepts surrounding AF in conjunction with a clinician tool and a non-clinician navigator to guide the participants through each step of the tool. The participant-determined primary outcome for this study is the Decisional Conflict Scale, measured at 1 month after the index visit during which a decision was made regarding anticoagulation use. Secondary outcomes at both 1 and 6 months will include other decision making related scales as well as participant and clinician satisfaction, oral anticoagulation adherence, and a composite rate of major bleeding, death, stroke, or transient ischemic attack. The study will be conducted at four sites selected for their ability to enroll participants of varying racial and ethnic backgrounds, health literacy, and language skills. Participants will be followed in the study for 6 months. CONCLUSIONS: The results of the ENHANCE-AF trial will determine whether a decision aid facilitates high quality shared decision making in anticoagulation discussions for stroke reduction in AF. An improved shared decision-making experience may allow patients to make decisions better aligned with their personal values and preferences, while improving overall AF care.

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.

Maternal and child health in yushu, qinghai province, china.

INTRODUCTION: Surmang, Qinghai Province is a rural nomadic Tibetan region in western China recently devastated by the 2010 Yushu earthquake; little information is available on access and coverage of maternal and child health services. METHODS: A cross-sectional household survey was conducted in August 2004. 402 women of reproductive age (15-50) were interviewed regarding their pregnancy history, access to and utilization of health care, and infant and child health care practices. RESULTS: Women's access to education was low at 15% for any formal schooling; adult female literacy was <20%. One third of women received any antenatal care during their last pregnancy. Institutional delivery and skilled birth attendance were <1%, and there were no reported cesarean deliveries. Birth was commonly attended by a female relative, and 8% of women delivered alone. Use of unsterilized instrument to cut the umbilical cord was nearly universal (94%), while coverage for tetanus toxoid immunization was only 14%. Traditional Tibetan healers were frequently sought for problems during pregnancy (70%), the post partum period (87%), and for childhood illnesses (74%). Western medicine (61%) was preferred over Tibetan medicine (9%) for preventive antenatal care. The average time to reach a health facility was 4.3 hours. Postpartum infectious morbidity appeared to be high, but only 3% of women with postpartum problems received western medical care. 64% of recently pregnant women reported that they were very worried about dying in childbirth. The community reported 3 maternal deaths and 103 live births in the 19 months prior to the survey. CONCLUSIONS: While China is on track to achieve national Millennium Development Goal targets for maternal and child health, women and children in Surmang suffer from substantial health inequities in access to antenatal, skilled birth and postpartum care. Institutional delivery, skilled attendance and cesarean delivery are virtually inaccessible, and consequently maternal and infant morbidity and mortality are likely high. Urgent action is needed to improve access to maternal, neonatal and child health care in these marginalized populations. The reconstruction after the recent earthquake provides a unique opportunity to link this population with the health system.