The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial.

BACKGROUND: Living related kidney transplantation (LRT) is underutilized, particularly among African Americans. The effectiveness of informational and financial interventions to enhance informed decision-making among African Americans with end stage renal disease (ESRD) and improve rates of LRT is unknown. METHODS/DESIGN: We report the protocol of the Providing Resources to Enhance African American Patients' Readiness to Make Decisions about Kidney Disease (PREPARED) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test the effectiveness of informational (focused on shared decision-making) and financial interventions to overcome barriers to pursuit of LRT among African American patients and their families. Study Phase I involved the evidence-based development of informational materials as well as a financial intervention to enhance African American patients' and families' proficiency in shared decision-making regarding LRT. In Study Phase 2, we are currently conducting a randomized controlled trial in which patients with new-onset ESRD receive 1) usual dialysis care by their nephrologists, 2) the informational intervention (educational video and handbook), or 3) the informational intervention in addition to the option of participating in a live kidney donor financial assistance program. The primary outcome of the randomized controlled trial will include patients' self-reported rates of consideration of LRT (including family discussions of LRT, patient-physician discussions of LRT, and identification of a LRT donor). DISCUSSION: Results from the PREPARED study will provide needed evidence on ways to enhance the decision to pursue LRT among African American patients with ESRD.

Outcomes After Total Ankle Replacement in Association With Ipsilateral Hindfoot Arthrodesis.

BACKGROUND: Ipsilateral hindfoot arthrodesis in combination with total ankle replacement (TAR) may diminish functional outcome and prosthesis survivorship compared to isolated TAR. We compared the outcome of isolated TAR to outcomes of TAR with ipsilateral hindfoot arthrodesis. METHODS: In a consecutive series of 404 primary TARs in 396 patients, 70 patients (17.3%) had a hindfoot fusion before, after, or at the time of TAR; the majority had either an isolated subtalar arthrodesis (n = 43, 62%) or triple arthrodesis (n = 15, 21%). The remaining 334 isolated TARs served as the control group. Mean patient follow-up was 3.2 years (range, 24-72 months). RESULTS: The SF-36 total, AOFAS Hindfoot-Ankle pain subscale, Foot and Ankle Disability Index, and Short Musculoskeletal Function Assessment scores were significantly improved from preoperative measures, with no significant differences between the hindfoot arthrodesis and control groups. The AOFAS Hindfoot-Ankle total, function, and alignment scores were significantly improved for both groups, albeit the control group demonstrated significantly higher scores in all 3 scales. Furthermore, the control group demonstrated a significantly greater improvement in VAS pain score compared to the hindfoot arthrodesis group. Walking speed, sit-to-stand time, and 4-square step test time were significantly improved for both groups at each postoperative time point; however, the hindfoot arthrodesis group completed these tests significantly slower than the control group. There was no significant difference in terms of talar component subsidence between the fusion (2.6 mm) and control groups (2.0 mm). The failure rate in the hindfoot fusion group (10.0%) was significantly higher than that in the control group (2.4%; p < 0.05). CONCLUSION: To our knowledge, this study represents the first series evaluating the clinical outcome of TARs performed with and without hindfoot fusion using implants available in the United States. At follow-up of 3.2 years, TAR performed with ipsilateral hindfoot arthrodesis resulted in significant improvements in pain and functional outcome; in contrast to prior studies, however, overall outcome was inferior to that of isolated TAR. LEVEL OF EVIDENCE: Level II, prospective comparative series.

Development and usability testing of a Web-based decision aid for families of patients receiving prolonged mechanical ventilation.

BACKGROUND: Web-based decision aids are increasingly important in medical research and clinical care. However, few have been studied in an intensive care unit setting. The objectives of this study were to develop a Web-based decision aid for family members of patients receiving prolonged mechanical ventilation and to evaluate its usability and acceptability. METHODS: Using an iterative process involving 48 critical illness survivors, family surrogate decision makers, and intensivists, we developed a Web-based decision aid addressing goals of care preferences for surrogate decision makers of patients with prolonged mechanical ventilation that could be either administered by study staff or completed independently by family members (Development Phase). After piloting the decision aid among 13 surrogate decision makers and seven intensivists, we assessed the decision aid's usability in the Evaluation Phase among a cohort of 30 surrogate decision makers using the Systems Usability Scale (SUS). Acceptability was assessed using measures of satisfaction and preference for electronic Collaborative Decision Support (eCODES) versus the original printed decision aid. RESULTS: The final decision aid, termed 'electronic Collaborative Decision Support', provides a framework for shared decision making, elicits relevant values and preferences, incorporates clinical data to personalize prognostic estimates generated from the ProVent prediction model, generates a printable document summarizing the user's interaction with the decision aid, and can digitally archive each user session. Usability was excellent (mean SUS, 80 ± 10) overall, but lower among those 56 years and older (73 ± 7) versus those who were younger (84 ± 9); p = 0.03. A total of 93% of users reported a preference for electronic versus printed versions. CONCLUSIONS: The Web-based decision aid for ICU surrogate decision makers can facilitate highly individualized information sharing with excellent usability and acceptability. Decision aids that employ an electronic format such as eCODES represent a strategy that could enhance patient-clinician collaboration and decision making quality in intensive care.