In advanced dementia, goals of care decisions are challenging and medical care is often more intensive than desired.OBJECTIVE To test a goals of care (GOC) decision aid intervention to improve quality of communication and palliative care for nursing home residents with advanced dementia. DESIGN, SETTING, AND PARTICIPANTSA single-blind cluster randomized clinical trial, including 302 residents with advanced dementia and their family decision makers in 22 nursing homes.INTERVENTIONS A GOC video decision aid plus a structured discussion with nursing home health care providers; attention control with an informational video and usual care planning.MAIN OUTCOMES AND MEASURES Primary outcomes at 3 months were quality of communication (QOC, questionnaire scored 0-10 with higher ratings indicating better quality), family report of concordance with clinicians on the primary goal of care (endorsing same goal as the "best goal to guide care and medical treatment," and clinicians' "top priority for care and medical treatment"), and treatment consistent with preferences (Advance Care Planning Problem score). Secondary outcomes at 9 months were family ratings of symptom management and care, palliative care domains in care plans, Medical Orders for Scope of Treatment (MOST) completion, and hospital transfers. Resident-family dyads were the primary unit of analysis, and all analyses used intention-to-treat assignment.RESULTS Residents' mean age was 86.5 years, 39 (12.9%) were African American, and 246 (81.5%) were women. With the GOC intervention, family decision makers reported better quality of communication (QOC, 6.0 vs 5.6; P = .05) and better end-of-life communication (QOC end-of-life subscale, 3.7 vs 3.0; P = .02). Goal concordance did not differ at 3 months, but family decision makers with the intervention reported greater concordance by 9 months or death (133 [88.4%] vs 108 [71.2%], P = .001). Family ratings of treatment consistent with preferences, symptom management, and quality of care did not differ. Residents in the intervention group had more palliative care content in treatment plans (5.6 vs 4.7, P = .02), MOST order sets (35% vs 16%, P = .05), and half as many hospital transfers (0.078 vs 0.163 per 90 person-days; RR, 0.47; 95% CI, 0.26-0.88). Survival at 9 months was unaffected (adjusted hazard ratio [aHR], 0.76; 95% CI, 0.54-1.08; P = .13). CONCLUSIONS AND RELEVANCEThe GOC decision aid intervention is effective to improve end-of-life communication for nursing home residents with advanced dementia and enhance palliative care plans while reducing hospital transfers. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01565642
Background Few trials have examined long-term outcomes of advance care planning (ACP) interventions. We examined the efficacy of an ACP intervention on preparation for end-of-life decision making for dialysis patients and surrogates and for surrogates’ bereavement outcomes. Study Design A randomized trial compared an ACP intervention (Sharing Patient’s Illness Representations to Increase Trust [SPIRIT]) to usual care alone, with blinded outcome assessments. Setting & Participants 420 participants (210 dyads of prevalent dialysis patients and their surrogates) from 20 dialysis centers. Intervention Every dyad received usual care. Those randomly assigned to SPIRIT had an in-depth ACP discussion at the center and a follow-up session at home 2 weeks later. Outcomes & Measurements Primary outcomes: preparation for end-of-life decision making, assessed for 12 months, included dyad congruence on goals of care at end of life, patient decisional conflict, surrogate decision-making confidence, and a composite of congruence and surrogate decision-making confidence. Secondary outcomes: bereavement outcomes, assessed for 6 months, included anxiety, depression, and posttraumatic distress symptoms completed by surrogates after patient death. Results Primary outcomes: adjusting for time and baseline values, dyad congruence (OR, 1.89; 95% CI, 1.1–3.3), surrogate decision-making confidence (β = 0.13; 95% CI, 0.01–0.24), and the composite (OR, 1.82; 95% CI, 1.0–3.2) were better in SPIRIT than controls, but patient decisional conflict did not differ between groups (β = −0.01; 95% CI, −0.12 to 0.10). Secondary outcomes: 45 patients died during the study. Surrogates in SPIRIT had less anxiety (β = −1.13; 95% CI, −2.23 to −0.03), depression (β = −2.54; 95% CI, −4.34 to −0.74), and posttraumatic distress (β = −5.75; 95% CI, −10.9 to −0.64) than controls. Limitations Study was conducted in a single US region. Conclusions SPIRIT was associated with improvements in dyad preparation for end-of-life decision making and surrogate bereavement outcomes.
Background Use of composite variables is a common practice, but knowledge about what researchers should consider when creating composite variables is lacking. Objective The purpose of this paper was to present methods used to create composite variables with attention to advantages and disadvantages. Methods Methods of simple averaging, weighted averaging, and meaningful grouping to create composite variables are described briefly, and the context in which one method might be more suitable than the others is discussed. Study examples and comparisons of statistical power among these methods as well as Bonferroni correction are described. Discussion Each approach to creating composite variables has advantages and disadvantages that researchers should weigh carefully. With normally distributed data, composite variables provide the greatest increases in power when the original variables (that make up the composite variable) have similar associations with the outside outcome variable.
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