Study protocols for the development and randomized controlled pilot trial of a patient decision aid to facilitate women's choice between oral and LAI ART for HIV (Preprint)

BACKGROUND Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill-taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women’s adherence and long-term HIV outcomes. OBJECTIVE This study will develop and pilot test a web-based patient decision aid, called i.ART+support (iARTs). This decision aid aims to support shared decision-making between WWH and their providers, and help women choose between oral and LAI HIV treatment. METHODS The study will occur in three phases. In Phase 1, we will utilize a mixed-methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During Phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In Phase 3, i.ARTs will be tested in a randomized controlled trial (RCT) with n=180 women in Miami, FL and assessed for feasibility, usability and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART refills, and clinic attendance. RESULTS Phase 1 participant recruitment began in September 2021. CONCLUSIONS This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed-methods design, and implementation in a real-world clinical setting. CLINICALTRIAL We will apply for Clinicaltrials.gov registration prior to Phase 3 when we enroll our first participant in the RCT. This is anticipated to occur in April 2023.

Using a patient decision aid about insulin treatment in type 2 diabetes clinics

The Candlin Researcher AwardThe low uptake of insulin leaves many Malaysians with type 2 diabetes at risk of developing complications. To improve decision making about insulin treatment, a patient decision aid (PDA) was developed for use with patients. However, although it is generally accepted that PDAs can support informed and shared decision making, there is limited discursive data showing how they are used in doctor–patient consultations. This paper reports on activity analysis of clinic consultations in which a PDA about insulin treatment was used. Eleven consultations with diverse participants conducted in three healthcare settings in Malaysia were systematically mapped to identify structural, interactional and thematic patterns. Two main phases of Assessment and Treatment were identified, with doctors generally participating more than patients. Mapping of the Treatment phase showed that structural patterns depended on two main factors: whether patients had read the PDA and whether they responded negatively or positively towards insulin. While mapping is only a preliminary stage of activity analysis, the findings offer insights into structural, interactional and thematic patterns in PDA use at the level of the whole consultation. They also point towards key areas for closer analysis of discursive practices.

Cardiology providers’ recommendations for treatments and use of patient decision aids for multivessel coronary artery disease

Background Rates of recommending percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) vary across clinicians. Whether clinicians agree on preferred treatment options for multivessel coronary artery disease patients has not been well studied. Methods and results We distributed a survey to 104 clinicians from the Northern New England Cardiovascular Study Group through email and at a regional meeting with 88 (84.6%) responses. The survey described three clinical vignettes of multivessel coronary artery disease patients. For each patient vignette participants selected appropriate treatment options and whether they would use a patient decision aid. The likelihood of choosing PCI only or PCI/CABG over CABG only was modeled using a multinomial regression. Across all vignettes, participants selected CABG only as an appropriate treatment option 24.2% of the time, PCI only 25.4% of the time, and both CABG or PCI as appropriate treatment options 50.4% of the time. Surgeons were less likely to choose PCI over CABG (RR 0.14, 95% CI 0.03, 0.59) or both treatments over CABG only (RR 0.10, 95% CI 0.03, 0.34) relative to cardiologists. Overall, 65% of participants responded they would use a patient decision aid with each vignette. Conclusions There is a lack of consensus on the appropriate treatment options across cardiologists and surgeons for patients with multivessel coronary artery disease. Treatment choice is influenced by both patient characteristics and clinician specialty.