Manali I Patel1,2,3,4, Vandana Sundaram5, Manisha Desai5, Vyjeyanthi S Periyakoil6,7, James S Kahn2,6, Jay Bhattacharya4,8, Steven M Asch2,6,9, Arnold Milstein3,6, M Kate Bundorf4,8. 1. Division of Oncology, Stanford University School of Medicine, Stanford, California. 2. Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, California. 3. Clinical Excellence Research Center, Stanford University School of Medicine, Stanford, California. 4. Center for Primary Care and Outcomes Research, Stanford University School of Medicine, Stanford, California. 5. Quantitative Sciences Unit, Department of Medicine, Stanford University School of Medicine, Stanford, California. 6. Division of Primary Care and Population Health, Stanford University School of Medicine, Stanford, California. 7. Extended Care Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, California. 8. Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California. 9. Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Palo Alto, California.
Abstract
Importance: Although lay health workers (LHWs) improve cancer screening and treatment adherence, evidence on whether they can enhance other aspects of care is limited. Objective: To determine whether an LHW program can increase documentation of patients' care preferences after cancer diagnosis. Design, Setting, and Participants: Randomized clinical trial conducted from August 13, 2013, through February 2, 2015, among 213 patients with stage 3 or 4 or recurrent cancer at the Veterans Affairs Palo Alto Health Care System. Data analysis was by intention to treat and performed from January 15 to August 18, 2017. Interventions: Six-month program with an LHW trained to assist patients with establishing end-of-life care preferences vs usual care. Main Outcomes and Measures: The primary outcome was documentation of goals of care. Secondary outcomes were patient satisfaction on the Consumer Assessment of Health Care Providers and Systems "satisfaction with provider" item (on a scale of 0 [worst] to 10 [best possible]), health care use, and costs. Results: Among the 213 participants randomized and included in the intention-to-treat analysis, the mean (SD) age was 69.3 (9.1) years, 211 (99.1%) were male, and 165 (77.5%) were of non-Hispanic white race/ethnicity. Within 6 months of enrollment, patients randomized to the intervention had greater documentation of goals of care than the control group (97 [92.4%] vs 19 [17.5%.]; P < .001) and larger increases in satisfaction with care on the Consumer Assessment of Health Care Providers and Systems "satisfaction with provider" item (difference-in-difference, 1.53; 95% CI, 0.67-2.41; P < .001). The number of patients who died within 15 months of enrollment did not differ between groups (intervention, 60 of 105 [57.1%] vs control, 60 of 108 [55.6%]; P = .68). In the 30 days before death, patients in the intervention group had greater hospice use (46 [76.7%] vs 29 [48.3%]; P = .002), fewer emergency department visits (mean [SD], 0.05 [0.22] vs 0.60 [0.76]; P < .001), fewer hospitalizations (mean [SD], 0.05 [0.22] vs 0.50 [0.62]; P < .001), and lower costs (median [interquartile range], $1048 [$331-$8522] vs $23 482 [$9708-$55 648]; P < .001) than patients in the control group. Conclusions and Relevance: Incorporating an LHW into cancer care increases goals-of-care documentation and patient satisfaction and reduces health care use and costs at the end of life. Trial Registration: ClinicalTrials.gov Identifier: NCT02966509.
RCT Entities:
Importance: Although lay health workers (LHWs) improve cancer screening and treatment adherence, evidence on whether they can enhance other aspects of care is limited. Objective: To determine whether an LHW program can increase documentation of patients' care preferences after cancer diagnosis. Design, Setting, and Participants: Randomized clinical trial conducted from August 13, 2013, through February 2, 2015, among 213 patients with stage 3 or 4 or recurrent cancer at the Veterans Affairs Palo Alto Health Care System. Data analysis was by intention to treat and performed from January 15 to August 18, 2017. Interventions: Six-month program with an LHW trained to assist patients with establishing end-of-life care preferences vs usual care. Main Outcomes and Measures: The primary outcome was documentation of goals of care. Secondary outcomes were patient satisfaction on the Consumer Assessment of Health Care Providers and Systems "satisfaction with provider" item (on a scale of 0 [worst] to 10 [best possible]), health care use, and costs. Results: Among the 213 participants randomized and included in the intention-to-treat analysis, the mean (SD) age was 69.3 (9.1) years, 211 (99.1%) were male, and 165 (77.5%) were of non-Hispanic white race/ethnicity. Within 6 months of enrollment, patients randomized to the intervention had greater documentation of goals of care than the control group (97 [92.4%] vs 19 [17.5%.]; P < .001) and larger increases in satisfaction with care on the Consumer Assessment of Health Care Providers and Systems "satisfaction with provider" item (difference-in-difference, 1.53; 95% CI, 0.67-2.41; P < .001). The number of patients who died within 15 months of enrollment did not differ between groups (intervention, 60 of 105 [57.1%] vs control, 60 of 108 [55.6%]; P = .68). In the 30 days before death, patients in the intervention group had greater hospice use (46 [76.7%] vs 29 [48.3%]; P = .002), fewer emergency department visits (mean [SD], 0.05 [0.22] vs 0.60 [0.76]; P < .001), fewer hospitalizations (mean [SD], 0.05 [0.22] vs 0.50 [0.62]; P < .001), and lower costs (median [interquartile range], $1048 [$331-$8522] vs $23 482 [$9708-$55 648]; P < .001) than patients in the control group. Conclusions and Relevance: Incorporating an LHW into cancer care increases goals-of-care documentation and patient satisfaction and reduces health care use and costs at the end of life. Trial Registration: ClinicalTrials.gov Identifier: NCT02966509.
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