Performance of Patient-Reported Outcome Measures in a Large Pragmatic Trial of Home-Based Palliative Care (HomePal): Methodological and Practical Considerations for Embedded Patient-Centered Design.

Background: The research enterprise has embraced patient centeredness in embedded efficient pragmatic trials, but limited data exist on using patient-reported outcomes (PROs) collected as part of usual clinical care for research. Objectives: We sought to assess the performance of different assessment methods for obtaining PROs in a pragmatic cluster randomized trial (HomePal study) designed to compare two models of home-based palliative care (HBPC). Design: Descriptive analytics, comparative trends, and psychometric performance of PROs collected in the HomePal study; measures included Edmonton Symptom Assessment System (ESAS), PROMIS-10, and others administered at baseline, 1, and 6 months. Setting/Subjects: HomePal was conducted in the Southern California and Northwest Kaiser Permanente regions in the United States; subjects were patients receiving HBPC and their caregivers. Measurements: We specifically compared ESAS obtained by research staff with those obtained by clinical HBPC nurses at the time of HBPC enrollment. We also compared ESAS completed by patients versus if done or assisted by a caregiver (proxy). Results: We enrolled 3533 patients and had 2205 ESAS measurements that met the criteria for analysis at baseline and 1447 at the one-month follow-up assessment. Research staff-obtained ESAS at admission to HBPC was higher overall (indicating more symptoms) than the clinically collected measure whether symptoms were reported by patients (31.7 ± 15.4 vs. 26.0 ± 13.4) or by proxies (36.9 ± 15.6 vs. 26.5 ± 13.5). These differences persisted with follow-up ESAS measures. Conclusions: We identified significant variability in PRO responses between different surveyors and whether proxy interaction was needed suggesting complex issues around PRO measure performance for pragmatic embedded trials. ClinicalTrials.gov Identifier: NCT03694431.

Assessing the concurrent validity of days alive and at home metric.

BACKGROUND: Most patients living with serious illness value spending time at home. Emerging data suggest that days alive and at home (DAH) may be a useful metric, however more research is needed. We aimed to assess the concurrent validity of DAH with respect to clinically significant changes in patient- and caregiver-reported outcomes (PROs). METHODS: We drew data from a study that compared two models of home-based palliative care among seriously ill patients and their caregivers in two Kaiser Permanente regions (Southern California and Northwest). We included participants aged 18 years or older (n = 3533) and corresponding caregivers (n = 463). We categorized patients and caregivers into three groups based on whether symptom burden (Edmonton Symptom Assessment System, ESAS) or caregiving preparedness (Preparedness for Caregiving Scale, CPS) showed improvements, deterioration, or no change from baseline to 1 month later. We measured DAH across four time windows: 30, 60, 90, and 180 days, after admission to home palliative care. We used two-way ANOVA to compare DAH across the PRO groups. RESULTS: Adjusted pairwise comparisons showed that DAH was highest for patients whose ESAS scores improved or did not change compared with those with worsening symptoms. Although the mean differences ranged from less than a day to about 3 weeks, none exceeded 0.3 standard deviations. ESAS change scores had weak negative correlations (r = -0.11 to -0.21) with DAH measures. CPS change scores also showed weak, positive correlations (r = 0.23-0.24) with DAH measures. CONCLUSION: DAH measures are associated, albeit weakly, with clinically important improvement or maintenance of patient symptom burden in a diverse, seriously ill population.

Refining a Taxonomy of Goals for Older Adults With Functional Limitations and Their Caregivers to Inform Care Planning.

Purpose: The purpose of the study is to capture goals expressed by older adults with functional limitations and their caregivers. Methods: Through focus groups and interviews, 76 older adults with ≥1 activity of daily living limitation and 28 family/friend caregivers were asked about what mattered most to them and their goals for care. Transcripts were coded using an existing taxonomy. Goals that did not fit the taxonomy were assigned new codes. Results: We identified more than 50 goals in eight domains. Domains included (a) Medical Care; (b) Quality of Life: Physical; (c) Quality of Life: Social and Emotional; (d) Access to Services and Supports; (e) Caregiver Needs and Concerns; (f) End of Life; (g) Independence; and (h) Acceptable Housing. Conclusion: While there is overlap between identified goals and the existing taxonomy, new goals emerged. The goal domains identified could serve as a framework to improve and measure the quality of goal-oriented care for older adults with complex needs.

Accountability for the Quality of Care Provided to People with Serious Illness.

BACKGROUND: Care for patients with serious illness is an emerging practice area that has gained attention as value-based purchasing has increased. While the number of programs is growing, their impact on care quality and outcomes is unknown. OBJECTIVE: With support from the Gordon and Betty Moore Foundation, the National Committee for Quality Assurance (NCQA) is assessing the feasibility of creating an accountability program focused on serious illness care. METHODS: This article describes the process of developing an accountability program, findings from our initial work, and our plans to develop measures for a serious illness care accountability program. We focused on three questions: 1. What patient populations should be targeted for measurement? 2. What entities have accountability for ensuring high-quality care for serious illness? 3. What structures, processes, and outcomes should be evaluated in an accountability program for serious illness care? RESULTS: Our environmental scan showed that the evidence base for specific patient populations or care models is not sufficiently mature to justify traditional structure and process measures. In visits to serious illness care programs, we observed different staffing models, care models, care settings, and payment structures. We found a gap between recommended inclusion criteria and services when compared to inclusion criteria and services offered by existing programs. CONCLUSIONS: To address the challenges, NCQA intends to develop outcome measures driven by patient and family priorities. Structure and process measures will focus on building organizations' capacity to measure outcomes, including patient engagement and outcomes, linked to patient goals.

Electronic end-of-life care registry: the Utah ePOLST initiative.

As a patient's end-of-life approaches, it is typical for the disease to be the focus of treatment instead of the dying patient. There is limited congruence between the care preferred by patients and the treatment actually delivered to patients during their end-of-life. The Physician Orders for Life-Sustaining Treatment Paradigm has been endorsed or is in development in all but three states and the District of Columbia in an effort to ensure that patients are provided with adequate opportunities to specify their end-of-life care preferences. However, most states are using paper forms to document these preferences which may be inaccessible when needed. We have developed an electronic end-of-life care registry that allows authorized users to store and retrieve information pertaining to patients' end-of-life care preferences. In this paper, we describe (a) the requirements identified for the registry from the users' perspective and (b) the design and development of the electronic registry.

Assessing decision-making capacity in elderly patients: the gynecologist's role.

To obtain informed consent, a physician must be able to assess a patient's capacity to consent to treatment. She must be able to understand the information, appreciate how it applies to her situation, rationally process it to make reasonable choices, and express herself. Medicine and law no longer view capacity as dichotomous (fully capable or absolutely not). Patients may be able to make some choices but not others. There is a legal point at which decision-making capacity should be transferred from a patient to a surrogate, but the patient need not be henceforth excluded from the decision-making process.