RESUMEN
Palliative care is traditionally delivered by specialty-trained palliative care teams. Because of a national workforce shortage of palliative care specialists, there is an urgent need to explore alternative models of palliative care delivery to meet the needs of patients living with serious illness. As part of a multisite randomized controlled trial, 2 registered nurses without previous palliative care experience were trained to deliver a primary palliative care intervention to patients with newly diagnosed lung cancer. The intervention focused on assessing and managing symptoms, psychosocial needs, education, and initiating goals-of-care discussions. The primary outcome, improved symptom burden and quality of life, was not statistically significant. Despite this finding, nurses addressed 5 of the 8 National Consensus Project Guidelines domains of quality palliative care: structure and processes of care; physical, psychological, and social aspects of care; and ethical and legal aspects. Patients' engagement in goals-of-care discussions, a measure of high-quality palliative care, increased. Clinical recommendations offered by the nurses to the patients' clinicians were addressed and accepted on a timely basis. Most patients rated satisfaction with the intervention as "very or extremely" satisfied. These findings may inform future nurse-led palliative care interventions on the specific quality domains of palliative care.
Asunto(s)
Neoplasias Pulmonares , Cuidados Paliativos , Humanos , Neoplasias Pulmonares/terapia , Rol de la Enfermera , Calidad de Vida , TeléfonoRESUMEN
Background: Specialist palliative care improves quality of life (QOL), symptom burden, and may prolong survival among patients with advanced lung cancer. Previous trials focused on advanced disease, and less is known about patients across a broad range of stages. Objective: We sought to assess the effect of a nurse-led telephone-based primary palliative care intervention that focused on patients across a broad range of stages. Design, Setting, and Participants: We conducted a multisite randomized controlled trial in the United States involving patients diagnosed within two months with any stage or histology of lung cancer to compare the effects of a telephone-based palliative care intervention delivered by registered nurses trained in primary palliative care versus usual care. Main Outcomes and Measures: The primary outcome was the Functional Assessment of Cancer Therapy-Lung Scale Total Outcome Index (FACT-L TOI), which measures QOL and symptoms. We estimated having 80% power to detect a 5-point change from baseline to three months. Secondary outcome was a change in satisfaction of care, measured by the FAMCARE-P13. Results: A total of 151 patients were enrolled over 30 months. Patients were, on average, male (98%), age 70 years, White (85%), and 36% diagnosed with stage I-II, and 64% had stage III-IV. In comparison to usual care, patients in the nurse-led intervention did not report improvement in QOL from baseline to three months follow-up or demonstrate differences in treatment effect by site or cancer stage: FACT-L TOI 1.03 (95% confidence interval [CI]: -3.98 to 6.04). Satisfaction with care did not significantly improve: 0.66 (95% CI: -2.01 to 3.33). Conclusions: Among patients with newly diagnosed lung cancer, a nurse-led, primary palliative care intervention did not significantly improve QOL, symptom burden, or satisfaction of care. In contrast to several clinical trials demonstrating the effectiveness of delivering specialty palliative care with disease-modifying treatments on QOL among patients with advanced lung cancer, this intervention did not significantly improve QOL among patients with any stage lung cancer. Future research should identify which specific components of primary palliative care improve outcomes for patients newly diagnosed with lung cancer.
Asunto(s)
Enfermería de Cuidados Paliativos al Final de la Vida , Neoplasias Pulmonares , Humanos , Masculino , Anciano , Cuidados Paliativos , Calidad de Vida , Rol de la EnfermeraRESUMEN
BACKGROUND: Most patients with alcohol use disorders (AUDs) never receive alcohol treatment, and experts have recommended management of AUDs in primary care. The Choosing Healthier Drinking Options In primary CarE (CHOICE) trial was a randomized controlled effectiveness trial of a novel intervention for primary care patients at high risk for AUDs. This report describes the conceptual and scientific foundation of the CHOICE model of care, critical elements of the CHOICE trial design consistent with the Template for Intervention Description and Replication (TIDieR), results of recruitment, and baseline characteristics of the enrolled sample. METHODS: The CHOICE intervention is a multi-contact, extended counseling intervention, based on the Chronic Care Model, shared decision-making, motivational interviewing, and evidence-based options for managing AUDs, designed to be practical in primary care. Outpatients who received care at 3 Veterans Affairs primary care sites in the Pacific Northwest and reported frequent heavy drinking (≥4 drinks/day for women; ≥5 for men) were recruited (2011-2014) into a trial in which half of the participants would be offered additional alcohol-related care from a nurse. CHOICE nurses offered 12 months of patient-centered care, including proactive outreach and engagement, repeated brief motivational interventions, monitoring with and without alcohol biomarkers, medications for AUDs, and/or specialty alcohol treatment as appropriate and per patient preference. A CHOICE nurse practitioner was available to prescribe medications for AUDs. RESULTS: A total of 304 patients consented to participate in the CHOICE trial. Among consenting participants, 90% were men, the mean age was 51 (range 22-75), and most met DSM-IV criteria for alcohol abuse (14%) or dependence (59%). Many participants also screened positive for tobacco use (44%), depression (45%), anxiety disorders (30-41%) and non-tobacco drug use disorders (19%). At baseline, participants had a median AUDIT score of 18 [Interquartile range (IQR) 14-24] and a median readiness to change drinking score of 5 (IQR 2.75-6.25) on a 1-10 Likert scale. CONCLUSION: The CHOICE trial tested a patient-centered intervention for AUDs and recruited primary care patients at high risk for AUDs, with a spectrum of severity, co-morbidity, and readiness to change drinking. Trial registration The trial is registered at clinicaltrial.gov (NCT01400581).