A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer: Protocol and key design considerations

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.

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Effects of an Oncology Nurse-Led, Primary Palliative Care Intervention (CONNECT) on Illness Expectations Among Patients With Advanced Cancer

JCO Oncology Practice ◽

10.1200/op.21.00573 ◽

2021 ◽

Author(s):

Lauren E. Sigler ◽

Andrew D. Althouse ◽

Teresa H. Thomas ◽

Robert M. Arnold ◽

Douglas White ◽

...

Keyword(s):

Palliative Care ◽

Life Expectancy ◽

Advanced Cancer ◽

Terminal Illness ◽

Treatment Options ◽

Secondary Analysis ◽

Cluster Randomized Trial ◽

Oncology Nurse ◽

Care Intervention ◽

Treatment Intent

PURPOSE: Patients with advanced cancer often have unrealistic expectations about prognosis and treatment. This study assessed the effect of an oncology nurse-led primary palliative care intervention on illness expectations among patients with advanced cancer. METHODS: This study is a secondary analysis of a cluster-randomized trial of primary palliative care conducted at 17 oncology clinics. Adult patients with advanced solid tumors for whom the oncologist would not be surprised if died within 1 year were enrolled. Monthly visits were designed to foster realistic illness expectations by eliciting patient concerns and goals for their medical care and empowering patients and families to engage in discussions with oncologists about treatment options and preferences. Baseline and 3-month questionnaires included questions about life expectancy, treatment intent, and terminal illness acknowledgment. Odds of realistic illness expectations at 3 months were adjusted for baseline responses, patient demographic and clinical characteristics, and intervention dose. RESULTS: Among 457 primarily White patients, there was little difference in realistic illness expectations at 3 months between intervention and standard care groups: 12.8% v 11.4% for life expectancy (adjusted odds ratio [aOR] = 1.15; 95% CI, 0.59 to 2.22; P = .684); 24.6% v 33.3% for treatment intent (aOR = 0.76; 95% CI, 0.44 to 1.27; P = .290); 53.6% v 44.7% for terminal illness acknowledgment (aOR = 1.28; 95% CI, 0.81 to 2.00; P = .288). Results did not differ when accounting for variation in clinic sites or intervention dose. CONCLUSION: Illness expectations are difficult to change among patients with advanced cancer. Additional work is needed to identify approaches within oncology practices that foster realistic illness expectations to improve patient decision making.

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Abstract P165: Improvement In Self-monitoring Frequency, Electronic Data Sharing, And Medication Changes In A Pragmatic Cluster-randomized Trial Of Home Blood Pressure Telemonitoring And Pharmacist Care (Hyperlink 3)

Hypertension ◽

10.1161/hyp.76.suppl_1.p165 ◽

2020 ◽

Vol 76 (Suppl_1) ◽

Author(s):

Karen L Margolis ◽

JoAnn M Sperl-Hillen ◽

Lauren A Crain ◽

Jeanette Y Ziegenfuss ◽

Leif I Solberg ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Baseline Survey ◽

Self Monitoring ◽

Care Intervention ◽

Cluster Randomized ◽

Medication Changes ◽

Pharmacist Care

Introduction: Telehealth and remote monitoring have become critical to patient access to care during the COVID-19 pandemic. We measured the effect of a telehealth care intervention on frequency, sharing methods, and clinical usage of home blood pressure (BP) measurements. Methods: Hyperlink 3 is an ongoing pragmatic cluster-randomized trial in 3072 patients with uncontrolled hypertension in 21 primary care clinics in an integrated health system. Clinics were randomized to Clinic-based Care (CC, 9 clinics, 1648 patients) or Telehealth Care (TC, 12 clinics, 1424 patients). TC patients were offered home BP telemonitoring with pharmacist care management. Patients were surveyed at baseline (Nov 2017 - Apr 2019) and after 6 mo of study enrollment. Results: In the TC group, about 37% of patients attended an intake pharmacist visit and 434 (30%) participated in home BP telemonitoring. Baseline surveys were completed by 1719 (56%) of patients at baseline (goal 50%) and 1301 (76%) of those completing the baseline survey completed the 6 mo survey (goal 75%). Baseline survey respondents' mean age was 62, 46% were men, 19% were black, and mean BP was 164/93 mm Hg. Nearly all patients (>90%) took antihypertensive medications (median 2). The odds ratio (OR) for change in measuring BP > 2 times/week vs. less often was 0.97 (95% CI 0.87 - 1.42) in CC, and 2.01 (95% CI 1.56 - 2.59) in TC. The OR for change in frequent measurement in TC vs CC was 2.08 (95% CI 1.45 - 2.97). Conclusions: A telehealth care intervention markedly increased the frequency of home BP self- monitoring, electronic data sharing, and data-driven BP medication changes, even though only a minority of TC patients received the intervention.

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Quality of Life in Palliative Cancer Care: Results From a Cluster Randomized Trial

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.18.3884 ◽

2001 ◽

Vol 19 (18) ◽

pp. 3884-3894 ◽

Cited By ~ 164

Author(s):

Marit S. Jordhøy ◽

Peter Fayers ◽

Jon Håvard Loge ◽

Marianne Ahlner-Elmqvist ◽

Stein Kaasa

Keyword(s):

Quality Of Life ◽

Palliative Care ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Life Questionnaire ◽

Eortc Qlq C30 ◽

Cluster Randomized ◽

Eortc Qlq ◽

The Impact

PURPOSE: To assess the impact of comprehensive palliative care on patients’ quality of life. The intervention was based on cooperation between a palliative medicine unit and the community service and was compared with conventional care. PATIENTS AND METHODS: A cluster randomized trial was carried out, with community health care districts defined as the clusters. Patients from these districts who had malignant disease and survival expectancy between 2 to 9 months were entered onto the trial. The main quality-of-life end points were physical and emotional functioning, pain, and psychologic distress assessed monthly by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) questionnaire and Impact of Event scale (IES). In total, 235 intervention patients and 199 controls were included. RESULTS: During the initial 4 months of follow-up, the compliance was good (72%) and comparable among treatment groups. No significant differences on any of the quality-of-life scores were found. At later assessments and for scores that were made within 3 months before death, there was also no consistent tendency in favor of any treatment group on the main outcomes or other EORTC QLQ-C30 scales/items. CONCLUSION: A general program of palliative care may be important to ensure flexibility and to meet the needs of terminally ill patients. However, to achieve improvements on a group level of the various dimensions of quality of life, specific interventions directed toward specific symptoms or problems may have to be defined, evaluated, and included in the program.

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A lay navigator‐led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial

Cancer ◽

10.1002/cncr.34044 ◽

2021 ◽

Author(s):

J. Nicholas Dionne‐Odom ◽

Andres Azuero ◽

Richard A. Taylor ◽

Chinara Dosse ◽

Avery C. Bechthold ◽

...

Keyword(s):

Palliative Care ◽

African American ◽

Randomized Trial ◽

Family Caregivers ◽

Advanced Cancer ◽

Early Palliative Care ◽

Rural Family ◽

Care Intervention ◽

Cancer Project

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Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial

European Heart Journal ◽

10.1093/eurheartj/ehaa055 ◽

2020 ◽

Vol 41 (30) ◽

pp. 2836-2844 ◽

Cited By ~ 10

Author(s):

Carline J van den Dries ◽

Sander van Doorn ◽

Frans H Rutten ◽

Ruud Oudega ◽

Sjef J C M van de Leur ◽

...

Keyword(s):

Atrial Fibrillation ◽

Primary Care ◽

Usual Care ◽

Randomized Trial ◽

Integrated Care ◽

Cluster Randomized Trial ◽

Easy Access ◽

Care Intervention ◽

All Cause Mortality ◽

Cluster Randomized

Abstract Aims To evaluate whether integrated care for atrial fibrillation (AF) can be safely orchestrated in primary care. Methods and results The ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged ≥65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72–83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37–0.82]. For non-cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27–0.82). For other adverse events, no statistically significant differences were observed. Conclusion In this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.

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