Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study).

INTRODUCTION: There are several different interventions available to promote shared decision making (SDM); however, little is known about the comparative effectiveness of different approaches. OBJECTIVE: To examine the impact of patient-directed and physician-directed decision support strategies on the quality of treatment decisions for hip and knee osteoarthritis (OA). TRIAL DESIGN: A 2×2 factorial randomised controlled trial. SETTING: One academic medical centre, one community hospital and one orthopaedic specialty hospital. PARTICIPANTS AND INTERVENTIONS: The enrolment targets were 8 surgeons and 1120 patients diagnosed with hip or knee OA. Patients were randomly assigned to receive one of two different decision aids (DAs) stratified by site. The DAs varied in length, content and the level of detail regarding treatment options. Both DAs were available by paper or online.Surgeons were randomly assigned to receive a report detailing patients' goals and treatment preferences at the time of the visit or not. Eligible patients received their assigned DA before their visit and completed three surveys: before the visit (timepoint (T)1), 1-week postvisit (T2) and 6 months from either the visit date or surgery date for patients who underwent surgery (T3). Study staff and participating surgeons were not blinded, but the statistician conducting the analyses was blinded to the arms. MAIN OUTCOME MEASURE AND ANALYSIS: The primary study outcome was decision quality, the percentage of patients who were well informed and received their preferred treatment. Secondary outcomes included involvement in decision making, surgical rates, health outcomes, decision regret and satisfaction. A logistic regression model with the generalised estimating equations approach was used to compare rates of decision quality between the groups and account for the clustering of patients within providers. ETHICS AND DISSEMINATION: Ethics approval was obtained through the institutional review board at the main site. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02729831; Pre-results.

Influence of newborn health messages on care-seeking practices and community health behaviors among participants in the Zambia Chlorhexidine Application Trial.

BACKGROUND: Identifying and understanding traditional perceptions that influence newborn care practices and care-seeking behavior are crucial to developing sustainable interventions to improve neonatal health. The Zambia Chlorhexidine Application Trial (ZamCAT), a large-scale cluster randomized trial, assessed the impact of 4% chlorhexidine on neonatal mortality and omphalitis in Southern Province, Zambia. The main purpose of this post-ZamCAT qualitative study was to understand the impact of newborn care health messages on care-seeking behavior for neonates and the acceptability, knowledge, and attitudes towards chlorhexidine cord care among community members and health workers in Southern Province. METHODS & FINDINGS: Five focus group discussions and twenty-six in-depth interviews were conducted with mothers and health workers from ten health centers (5 rural and 5 peri-urban/urban). Community perceptions and local realities were identified as fundamental to care-seeking decisions and influenced individual participation in particular health-seeking behaviors. ZamCAT field monitors (data collectors) disseminated health messages at the time of recruitment at the health center and during subsequent home visits. Mothers noted that ZamCAT field monitors were effective in providing lessons and education on newborn care practices and participating mothers were able to share these messages with others in their communities. Although the study found no effect of chlorhexidine cord washes on neonatal mortality, community members had positive views towards chlorhexidine as they perceived that it reduced umbilical cord infections and was a beneficial alternative to traditional cord applications. CONCLUSION: The acceptability of health initiatives, such as chlorhexidine cord application, in community settings, is dependent on community education, understanding, and engagement. Community-based approaches, such as using community-based cadres of health workers to strengthen referrals, are an acceptable and potentially effective strategy to improve care-seeking behaviors and practices.