Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.

2021 ◽  
Vol 39 (36_suppl) ◽  
pp. 349527-349527
Author(s):  
Ethan Basch ◽  
Deborah Schrag ◽  
Jennifer Jansen ◽  
Sydney Henson ◽  
Angela M. Stover ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Symptom Monitoring ◽  
Community Oncology ◽  
Electronic Alerts ◽  
Patient Reported ◽  
Cluster Randomized

349527 Background: Symptoms are common during cancer care but often go undetected. Digital systems that elicit patient-reported outcomes (PRO) surveys may detect symptoms early and prompt clinicians to intervene, thereby alleviating suffering and averting complications. Methods: In a cluster-randomized trial, U.S.-based community oncology practices were randomized 1:1 to digital symptom monitoring with PRO surveys, or to usual care control. Patients receiving systemic treatment for metastatic cancer were eligible. At PRO practices, participants were invited to complete a weekly survey via web or automated telephone system for up to one year, including questions about nine common symptoms, performance status, and falls. Severe or worsening symptoms triggered electronic alerts to care team nurses, and reports showing longitudinal symptom data were available to oncologists at visits. Pre-specified secondary outcomes included impact on physical function, symptom control, and health-related quality of life (HRQL). The primary outcome of survival is not yet mature. Results: At 52 practices, 1,191 patients were eligible and enrolled (593 PRO; 598 control). Clinically meaningful benefits were experienced in physical function by 13.8% more patients with PRO versus control (P=0.009); symptom control by 16.1% (P=0.003); and HRQL by 13.4% (P=0.006). Mean changes from baseline were superior with PRO versus control for physical function (mean difference 2.47, 95% CI 0.41-4.53; P=0.02), symptom control (2.56, 0.95-4.17; P=0.002), and HRQL (2.43, 0.90-3.96; P=0.002). Patients completed 20,565/22,486 (91.5%) of expected weekly PRO surveys. Conclusions: Digital symptom monitoring during cancer treatment confers clinical benefits. Clinical trial information: NCT03249090.

Cluster-randomized trial of early palliative care for patients with metastatic cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9003-9003 ◽  
Author(s):  
Camilla Zimmermann ◽  
Nadia Swami ◽  
Gary Rodin ◽  
Ian Tannock ◽  
Monika K. Krzyzanowska ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Trial ◽  
Symptom Severity ◽  
Metastatic Cancer ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Satisfaction With Care ◽  
Early Palliative Care ◽  
Cluster Randomized

9003 Background: Patients with metastatic cancer have compromised quality of life (QOL), which tends to worsen towards the end of life. We conducted a cluster-randomized trial of early versus routine palliative care in patients with metastatic cancer, to assess impact on QOL, symptom control and satisfaction with care. Methods: Twenty-four medical oncology clinics were randomized, stratified by tumour site (4 lung clinics, 8 gastrointestinal, 4 genito-urinary, 6 breast, 2 gynecological), to intervention and follow-up (at least monthly) by a palliative care team, or to routine cancer care. Eligible patients had ECOG performance status 0-2 and a clinical prognosis of 6 months to 2 years. Patients completed measures of QOL (FACIT-Sp, including physical, social, emotional, functional and spiritual well-being; range 0-156, with higher scores indicating better QOL), symptom severity (Edmonton Symptom Assessment System; range 0-90, with higher scores indicating worse symptom severity), and satisfaction with care (FAMCARE-P16; score range 16-80) at baseline and monthly for 4 months. The primary outcome was the change in FACIT-Sp at 3 months. The planned sample size was 225 patients per arm, assuming 80% power and a 2-sided significance level of 0.05. Results: From December 2006 to September 2010, 461 patients completed baseline measures (228 intervention, 233 control); 442 patients completed at least one follow-up assessment (mean patients/cluster 18.8±11.6 control, 18.1±12.6 intervention). At 3 months, patients in the intervention group had marginally improved QOL (mean change in intervention vs. control, 1.6±14.5 vs. -2.0±13.6, p=0.07) but not symptom severity (0.1±16.9 vs. 2.1±13.9, p=0.34). At 4 months the change in QOL was more marked (2.5±15.5 vs. -4.0±14.2, p=0.008) and symptom severity was marginally better (-1.3±16.0 vs. 3.2±13.9, p=0.05). Improvement in satisfaction with care was evident at one month (p=0.001) and remained significant at both 3 months (2.3±9.1 vs.-1.8±8.2, p=0.001) and 4 months (3.7±8.6 vs. -2.4±8.3, p<0.001). Conclusions: In patients with metastatic cancer, early palliative care intervention immediately improved satisfaction with care, while QOL and symptom control improved later.

Nurse, oncologist, and patient impressions of electronic symptom monitoring via patient-reported outcomes in community oncology practices: Qualitative results from the U.S. national PRO-TECT trial (AFT-39, NCT03249090).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7044-7044
Author(s):  
Ethan M. Basch ◽  
Randall Teal ◽  
Amylou C. Dueck ◽  
Jennifer Jansen ◽  
Sydney Henson ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Patient Reported Outcomes ◽  
Positive Impact ◽  
Care Delivery ◽  
Routine Care ◽  
Office Visits ◽  
Symptom Monitoring ◽  
Community Oncology ◽  
Patient Reported

7044 Background: There is growing interest to implement electronic patient-reported outcomes in oncology practices for symptom monitoring. It is not well known what nurse, physician, and patient impressions of benefits, acceptability, and challenges are in routine care use. Methods: PRO-TECT is an ongoing U.S. national trial including 26 community oncology practices across 15 states that implemented PRO symptom monitoring [NCT03249090]. Patients complete weekly PROs between visits, nurses receive alerts for severe/worsening symptoms, and oncologists review PROs at office visits. Interviews were conducted with 147 stakeholders including nurses (N = 46), oncologists (N = 27), data managers (N = 15), and patients (N = 59). Each stakeholder group had different interview guides with overlapping topics to explore experiences with the PRO system. Interviews lasted 15-60 minutes, were digitally recorded, transcribed, and entered into a qualitative analysis software program. A codebook was developed from the research questions, interview guides, and discussions with the project team. Standardized coding methods were applied, with transcripts double coded for thematic analysis. Feedback surveys were also completed by nurses (N = 57), oncologists (N = 38), and patients (N = 435). Results: Key benefits perceived across stakeholder groups included increased patient self-awareness of symptoms; improved direct communication of patients with care teams; more open and honest conveying of symptom experiences; ability to track symptoms over time; and increased involvement of patients in their own care. Most stakeholders felt PRO symptom monitoring had a positive impact on quality of care delivery, and believed benefits of PROs outweighed necessary staff efforts. Challenges included additional work by nurses to review and respond to alerts, staff turnover requiring retraining, and limited time of oncologists. In the survey, 39/56 (70%) nurses felt the PRO system improved quality of care; 27/33 (82%) oncologists noted PROs were useful for team discussions and care delivery; and 320/434 (74%) patients agreed that weekly PRO reporting improved discussions with their care team. Conclusions: Clinicians and patients perceived weekly PRO symptom monitoring between visits to be valuable despite added staff effort. Results of additional analyses are forthcoming. Clinical trial information: NCT03249090 .

scholarly journals Implementation of Electronic Patient-Reported Outcomes for Symptom Monitoring in a Large Multisite Community Oncology Practice: Dancing the Texas Two-Step Through a Pandemic

2021 ◽  
pp. 615-621
Author(s):  
Debra Patt ◽  
Lalan Wilfong ◽  
Kathryn Elizabeth Hudson ◽  
Amila Patel ◽  
Holly Books ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Text Message ◽  
Well Being ◽  
Ease Of Use ◽  
Self Report ◽  
Symptom Monitoring ◽  
Community Oncology ◽  
Patient Reported ◽  
Oncology Practice ◽  
E Mail

PURPOSE Among patients receiving chemotherapy, symptom monitoring with electronic patient-reported outcomes (ePROs) is associated with improved clinical outcomes, satisfaction, and compliance with therapy. Standard approaches for ePRO implementation are not established, warranting evaluation in community cancer practices. We present implementation findings of ePRO symptom monitoring across a large multisite community oncology practice network. METHODS Patients initiating a new systemic therapy at one of the 210 practice sites at Texas Oncology were invited to use the Navigating Cancer ePRO platform, with stepped-wedge implementation from July to December 2020. Participating patients received a weekly prompt by text message or e-mail to self-report common symptoms and well-being. Severe self-reported symptoms triggered a real-time notification to nursing triage to address the symptom. Enrollment and compliance were systematically tracked weekly with evaluation of barriers and facilitators to adoption and sustainability. RESULTS Four thousand three hundred seventy-five patients planning systemic treatment were enrolled and participated. Seventy-three percent (1,841 of 2,522) of enrolled patients completed at least one ePRO assessment. Among these individuals, 64% (16,299 of 25,061) of available weekly ePRO assessments were completed. Over a 10-week period, compliance declined from 72% to 52%. Barriers currently being addressed include lack of a second reminder text or e-mail prompt, inconsistent discussion of reported ePROs by clinicians at visits, and COVID-related changes in workflow. Facilitators included ease of use and patient and staff engagement on the importance of PROs for symptom management. CONCLUSION ePROs can be effectively implemented in community oncology practice. Utilization of ePROs is high but diminishes over time without attention to barriers. Ongoing work to address barriers and optimize compliance are underway.

scholarly journals Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (Supplement_2) ◽  
pp. S62-S72
Author(s):  
Steven Z George ◽  
Cynthia J Coffman ◽  
Kelli D Allen ◽  
Trevor A Lentz ◽  
Ashley Choate ◽  
...  
Keyword(s):  
Back Pain ◽  
Randomized Trial ◽  
Short Form ◽  
Integrated Management ◽  
Cluster Randomized Trial ◽  
Care Utilization ◽  
Measurement Information ◽  
Care Pathways ◽  
Patient Reported ◽  
Cluster Randomized

Abstract Background Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown. Design The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures. Summary AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.

scholarly journals Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lila J. Finney Rutten ◽  
Kathryn J. Ruddy ◽  
Linda L. Chlan ◽  
Joan M. Griffin ◽  
Jeph Herrin ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Cluster Randomized

scholarly journals Clinical Effects of Assessing Electronic Patient-Reported Outcomes Monitoring Symptomatic Toxicities During Breast Cancer Therapy – A Nationwide and Population-Based Study

2020 ◽  
Author(s):  
Helle Pappot ◽  
Christina W. Baeksted ◽  
Aase Nissen ◽  
Ann Knoop ◽  
Sandra A. Mitchell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Patient Reported Outcomes ◽  
Empirical Studies ◽  
Cluster Randomized Trial ◽  
Population Based ◽  
Public Health Care ◽  
Clinical Effects ◽  
Cultural Narrative ◽  
Patient Reported ◽  
Cluster Randomized

Abstract The involvement of cancer patients in symptom reporting talks into our cultural narrative of empowerment and participation in decisions in health of both patients and professionals. Electronic Patient Reported Outcomes (ePRO) is a tool applied for use in such interaction. Based on limited evidence and few empirical studies, health systems are rapidly implementing this instrument in managing patients in active treatment and in follow-up. In a cluster randomized trial of all Danish oncology departments treating breast cancer with adjuvant chemotherapy, we applied ePRO in 347 patients consecutively recruited. Our primary outcome, which was at least one treatment adjustment, was not significantly influenced using ePRO, 34% in the ePRO arm and 41% in the usual care arm received at least one treatment adjustment, p=0,095. Number of hospitalizations and events of febrile neutropenia was not influenced by the intervention. We believe that one of the main reasons for this finding could be the application of PRO in a well-regulated treatment setting within a public health care system where the most impacting symptomatic toxicities are already taken care off.ClinicalTrials.gov Identifier: NCT02996201, registered 19 December 2016, retrospectively registered.

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