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

Becker, Claire L.; Arnold, Robert M.; Park, Seo Young; Rosenzweig, Margaret; Smith, Thomas J.; White, Douglas B.; Smith, Kenneth J.; Schenker, Yael

doi:10.1016/j.cct.2017.01.005

Cited by 39 publications

(47 citation statements)

References 51 publications

(43 reference statements)

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“…A pilot study was conducted using oncology clinic nurses trained in a care management intervention to facilitate symptom assessment, engage in ACP, provide emotional support to patients and caregivers, and communicate with other oncology team members . This model was feasible and acceptable to patients, families, and oncologists; a cluster RCT of this intervention is ongoing . Of note, care delivered by oncology teams alone was the control arm in several RCTs demonstrating improved quality of life when a palliative care team was also involved .…”

Section: Innovative Models Of Care Deliverymentioning

confidence: 99%

“…116 This model was feasible and acceptable to patients, families, and oncologists; a cluster RCT of this intervention is ongoing. 117 Of note, care delivered by oncology teams alone was the control arm in several RCTs demonstrating improved quality of life when a palliative care team was also involved. 25,26,29,44 In one of those trials, patients perceived clear differences in the focus (disease vs person/family), motive (managing cancer treatment vs managing symptoms), and model of care (physician-led, time-constrained vs patient-led, flexible) in oncology versus palliative care clinics.…”

Section: Palliative Care Delivered By Oncology Teamsmentioning

confidence: 99%

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Improving patient and caregiver outcomes in oncology: Team‐based, timely, and targeted palliative care

Hui

Hannon

Zimmermann

et al. 2018

CA A Cancer J Clinicians

290

272

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Over the past decade, a large body of evidence has accumulated supporting the integration of palliative care into oncology practice for patients with advanced cancer. The question is no longer whether palliative care should be offered, but what is the optimal model of delivery, when is the ideal time to refer, who is in greatest need of a referral, and how much palliative care should oncologists themselves be providing. These questions are particularly relevant given the scarcity of palliative care resources internationally. In this state-of-science review directed at the practicing cancer clinician, we will first discuss the contemporary literature examining the impact of specialist palliative care on various health outcomes. We will then provide conceptual models to support team-based, timely and targeted palliative care. Team-based palliative care allows the interdisciplinary members to address comprehensively the multi-dimensional care needs of patients and their caregivers. Timely palliative care, at its best, is preventative care to minimize crises at the end-of-life. Targeted palliative care involves identifying patients most likely to benefit from specialist palliative care interventions, akin to the concept of targeted cancer therapies. Finally, we will summarize the strengths and weaknesses of innovative care models, such as outpatient clinics, embedded clinics, nurse-led palliative care, primary palliative care provided by oncology teams, and automatic referral. Moving forward, more research is needed to determine how different health systems can best personalize palliative care to provide the right level of intervention, for the right patient, in the right setting, at the right time.

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Section: Innovative Models Of Care Deliverymentioning

confidence: 99%

Section: Palliative Care Delivered By Oncology Teamsmentioning

confidence: 99%

Improving patient and caregiver outcomes in oncology: Team‐based, timely, and targeted palliative care

Hui

Hannon

Zimmermann

et al. 2018

CA A Cancer J Clinicians

290

272

View full text Add to dashboard Cite

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“…CONNECT (Care management by Oncology Nurses to address supportive care needs) is an intervention in which existing oncology nurses are identified and trained to provide primary palliative care within oncology practices. The protocol for a cluster-randomized trial evaluating the impact of CONNECT versus usual care on outcomes among patients with advanced cancer and their caregivers has been published previously [ 4 ]. No prior analysis has focused on interventionist training or intervention fidelity monitoring and maintenance.…”

Section: Methodsmentioning

confidence: 99%

“…We convened a Nurse Advisory Board, led by a Nurse Project Manager (PM) with palliative care expertise, to assist with identifying and training nurses to deliver the intervention. Participating sites nominated candidates who had strong relationships with clinicians and staff, excellent communication and interpersonal skills, an interest in learning new skills, and a commitment to palliative oncology care [ 4 ]. Preferred candidates had a minimum of 5 years of oncology nursing experience and Oncology Nursing Society (ONS) certification.…”

Section: Methodsmentioning

confidence: 99%

“…CONNECT visits take place at the same time as a patient's regularly scheduled oncology clinic appointment, occur monthly for at least 3 months, and may be conducted via telephone if a patient is unable to attend in person. A pilot trial demonstrated excellent feasibility, acceptability, and perceived effectiveness [ 3 ], and a multi-site cluster randomized efficacy trial is underway (Clinical Trials.gov NCT02712229) [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

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Interventionist training and intervention fidelity monitoring and maintenance for CONNECT, a nurse-led primary palliative care in oncology trial

Robbins-Welty¹,

Mueser

Mitchell

et al. 2018

Contemporary Clinical Trials Communications

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ContextIntervention fidelity is a critical component of behavioral research that has received inadequate attention in palliative care studies. With increasing focus on the need for palliative care models that can be widely disseminated and delivered by non-specialists, rigorous yet pragmatic strategies for training interventionists and maintaining intervention fidelity are needed.Objectives(1) Describe components of a plan for interventionist training and monitoring and maintaining intervention fidelity as part of a primary palliative care trial (CONNECT) and (2) present data about perceived training effectiveness and delivery of key intervention content.MethodsPost-training evaluations, visit checklists, and visit audio-recordings.ResultsData were collected from June, 2016 through April, 2017. We include procedures for (1) identification, training and certification of oncology nurses as CONNECT interventionists; (2) monitoring intervention delivery; and (3) maintaining intervention quality. All nurses (N = 14) felt prepared to deliver key competencies after a 3-day in-person training. As assessed via visit checklists, interventionists delivered an average of 94% (SD 13%) of key content for first intervention visits and 85% (SD 14%) for subsequent visits. As assessed via audio-recordings, interventionists delivered an average of 85% (SD 8%) of key content for initial visits and 85% (SD 12%) for subsequent visits.ConclusionWe present a 3-part strategy for training interventionists and monitoring and maintaining intervention delivery in a primary palliative care trial. Training was effective in having nurses feel prepared to deliver primary palliative care skills. As assessed via nursing checklists and visit audio-recordings, intervention fidelity was high.

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Effect of an Oncology Nurse–Led Primary Palliative Care Intervention on Patients With Advanced Cancer

et al. 2021

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IMPORTANCE Guidelines recommend early specialty palliative care for all patients with advanced cancer, but most patients lack access to such services.OBJECTIVE To assess the effect of CONNECT (Care Management by Oncology Nurses to Address Supportive Care Needs), a primary palliative care intervention delivered by oncology nurses, on patient outcomes. DESIGN, SETTING, AND PARTICIPANTS This cluster randomized clinical trial of the CONNECT intervention vs standard care was conducted from July 25, 2016, to October 6, 2020. Participants were adult patients with metastatic solid tumors who were undergoing oncological care and for whom an oncologist would agree with the statement "would not be surprised if the patient died in the next year." The trial was conducted at 17 community oncology practices in western Pennsylvania. Data analyses adhered to the intention-to-treat principle. INTERVENTIONSThe CONNECT intervention included 3 monthly visits with an existing infusion room nurse who was trained to address symptoms, provide emotional support, engage in advance care planning, and coordinate care. MAIN OUTCOMES AND MEASURESThe primary outcome was quality of life. At baseline and 3 months, participants completed assessments of quality of life (Functional Assessment of Chronic Illness Therapy-Palliative care: score range, 0-184, with higher scores indicating better quality of life), symptom burden (Edmonton Symptom Assessment Scale: score range, 0-90, with higher scores indicating greater symptom burden), and mood symptoms (Hospital Anxiety and Depression Scale [HADS]: score range, 0-21, with higher scores indicating substantial anxiety and depression). Linear mixed-effects models were used to estimate adjusted mean differences in 3-month outcomes. Preplanned, intensity-adjusted analyses were conducted.RESULTS A total of 672 patients were enrolled (mean [SD] age, 69.3 [10.2] years; 360 women [53.6%]). The mean (SD) number of CONNECT visits completed was 2.2 (1.0). At 3 months, no difference in mean (SD) quality-of-life score was found between the CONNECT and standard care groups (130.7 [28.2] vs 134.1 [28.1]; adjusted mean difference, 1.20; 95% CI, −2.75 to 5.15; P = .55). Similarly, there was no difference between groups in 3-month mean (SD) symptom burden (23.2 [16.6] vs 24.0 [16.1]; adjusted mean difference, −2.64; 95% CI, −5.85 to 0.58; P = .11) or mood symptoms (HADS depression subscale score: 5.1 [3.4] vs 4.8 [3.7], adjusted mean difference, −0.08 [95% CI, −0.71 to 0.57], P = .82; HADS anxiety subscale score: 5.7 [3.9] vs 5.4 [4.2], adjusted mean difference, −0.31 [95% CI, −0.96 to 0.33], P = .34). Intensity-adjusted analyses revealed a larger estimated treatment effect for patients who received a full dose (3 visits) of the CONNECT intervention.CONCLUSIONS AND RELEVANCE This cluster randomized clinical trial found that a primary palliative care intervention that was delivered by oncology nurses did not improve patient-reported outcomes at 3 months. Primary palliative care interventions with a higher dose intensity...

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

Cited by 39 publications

References 51 publications

Improving patient and caregiver outcomes in oncology: Team‐based, timely, and targeted palliative care

Improving patient and caregiver outcomes in oncology: Team‐based, timely, and targeted palliative care

Interventionist training and intervention fidelity monitoring and maintenance for CONNECT, a nurse-led primary palliative care in oncology trial

Effect of an Oncology Nurse–Led Primary Palliative Care Intervention on Patients With Advanced Cancer

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