Trial Summary
What is the purpose of this trial?The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.
Is the Telehealth Serious Illness Care Program a promising treatment for myeloid leukemia?Yes, the Telehealth Serious Illness Care Program is promising for myeloid leukemia. It helps patients share their values and goals with their care team, leading to better communication and care that aligns with what matters most to them. It also makes important conversations about their illness more common and routine, which can improve their understanding and reduce anxiety.12378
What data supports the idea that Telehealth Advance Care Planning for Myeloid Leukemia is an effective treatment?The available research shows that the Telehealth Advance Care Planning, adapted from the Serious Illness Care Program (SICP), helps older patients with myeloid leukemia share their personal values with their care team. This program improves the quality and frequency of important conversations about patients' values and goals. Participants, including patients and caregivers, believe it helps them understand their diagnosis better and aligns care with what matters most to them. While the research is ongoing, these findings suggest that the treatment is effective in enhancing communication and aligning care with patient values.45789
What safety data exists for the telehealth advance care planning treatment for myeloid leukemia?The Serious Illness Care Program (SICP), adapted for telehealth, has been shown to improve the quality and frequency of advance care planning discussions for patients with serious illnesses, including older patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). While specific safety data is not detailed, the program has been positively received by clinicians, patients, and caregivers, indicating its potential to align patient care with personal values. The adapted SICP is currently being evaluated in an ongoing pilot study.56789
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for individuals aged 60 or older with certain blood disorders, including acute myeloid leukemia and myelodysplastic syndrome. Participants must be receiving outpatient care, able to give informed consent, and speak English.Treatment Details
The study is testing a telehealth program designed to improve healthcare communication and reduce patient anxiety. It also aims to increase the completion of advance directives like MOLST (medical orders for life-sustaining treatment) forms.
2Treatment groups
Experimental Treatment
Group I: Telehealth Serious Illness Care ProgramExperimental Treatment1 Intervention
The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).
Group II: ControlExperimental Treatment1 Intervention
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
Telehealth Serious Illness Care Program is already approved in United States for the following indications:
🇺🇸 Approved in United States as Serious Illness Care Program for:
- Advance care planning for serious illnesses such as acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of RochesterRochester, NY
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Who is running the clinical trial?
University of RochesterLead Sponsor
References
Advance Care Planning and Palliative Care Integration for Patients Undergoing Hematopoietic Stem-Cell Transplantation. [2020]Advance care planning (ACP) in hematopoietic stem-cell transplantation (HSCT) is challenging, given the potential for cure despite increased morbidity and mortality risk.The aim of this study was to evaluate ACP and palliative care (PC) integration for patients who underwent HSCT.
Access to Palliative Care Consultation and Advance Care Planning for Adults with High-Risk Leukemia. [2019]Although strong evidence supports early palliative care (PC) and consistent advance care planning (ACP) for patients with poor-prognosis Stage IV solid tumors, best practice standards have not been established for hematologic malignancies. Our primary objective was to describe current access to specialty PC consultation and ACP for inpatients with high-risk leukemia. Secondary objectives were to describe components of ACP and PC practices.
Perspectives on Advance Care Planning for Patients with Hematologic Malignancy: An International Clinician Questionnaire. [2021]Rationale: Critical illness is common in patients with hematologic malignancy (HM). Advance care planning (ACP) can allow these patients to express their care preferences before life-threatening illnesses. Objectives: To evaluate physicians' perspectives surrounding ACP in patients with HM. Methods: We administered a survey to intensivists and hematologic oncologists who care for patients with HM across Canada and the United Kingdom. Potential respondents were identified from institutions that have a hematologic-oncology program. The survey was disseminated electronically. Results: A total of 111 physicians completed the survey, with a response rate of 19% (39% across those who opened the e-mail); 52% of respondents were intensivists, and 48% of respondents were hematologic oncologists. Of the responses, 15.5% of physicians reported that ACP happens routinely at their institution, whereas 8.3% of physicians stated that code status is routinely discussed. ACP discussions were most commonly reported at the onset of critical illness (84.3% of respondents), during disease recurrence (52.9% of respondents), or during the transition to a strictly palliative approach (54.9% of respondents). Commonly cited barriers to ACP centered on physicians' concern about the reaction of the patient or family. Conclusions: This study emphasizes the need for earlier and more frequent ACP discussions in this high-risk population with a variety of barriers identified.
Real World Implementation of the Serious Illness Care Program in Cancer Care: Results of a Quality Improvement Initiative. [2021]Purpose: Guidelines suggest that advance care planning (ACP) and goals-of-care discussions should be conducted for patients with advanced cancer early in the course of their disease. A recent audit of our health system found that these discussions were rarely being documented in the electronic medical record (EMR). We conducted a quality improvement initiative to improve rates of documentation of goals and wishes among patients with advanced cancer. Methods: On the basis of previous analyses of this problem, we determined that provider capability and opportunity were the main barriers to conducting and documenting serious illness conversations. We implemented the serious illness care program (SICP), a systematic multicomponent intervention that has shown potential for conducting and documenting ACP discussions in two oncology clinics. Our goal was to conduct at least 24 serious illness conversations over the implementation period, with documentation of at least 95% of all conversations. Results: The SICP was implemented in two outpatient medical oncology clinics. A total of 15 serious illness care conversations occurred and 14 (93%) of these conversations were documented in the EMR. Total rates of documentation increased between the preimplementation and implementation period (4.2%-5.4% for clinician A and 0%-7.3% for clinician B). Conclusion: Implementation of the SICP resulted in increased rates of documentation, but the target number of conversations was not met. Further improvement cycles are required to address barriers to conducting and documenting routine serious illness conversations.
Clinicians' Perspectives After Implementation of the Serious Illness Care Program: A Qualitative Study. [2022]Discussions about goals of care with patients who are seriously ill typically occur infrequently and late in the illness trajectory, are of low quality, and focus narrowly on the patient's resuscitation preferences (ie, code status), risking provision of care that is inconsistent with patients' values. The Serious Illness Care Program (SICP) is a multifaceted communication intervention that builds capacity for clinicians to have earlier, more frequent, and more person-centered conversations.
Serious Illness Care Programme-contextual factors and implementation strategies: a qualitative study. [2022]The Serious Illness Care Programme (SICP) is a multicomponent evidence-based intervention that improves communication about patients' values and goals in serious illness. We aim to characterise implementation strategies for programme delivery and the contextual factors that influence implementation in three 'real-world' health system SICP initiatives.
The Serious Illness Care Program in Oncology: Evidence, Real-World Implementation and Ongoing Barriers. [2022]The Serious Illness Care Program (SICP), designed by Ariadne Labs, is a multicomponent intervention to improve conversations about values and goals for patients with a life-limiting illness. In oncology, implementation of the SICP achieved more, earlier, and better-quality conversations and reduced anxiety and depression among patients with advanced cancer. In this commentary, we describe the SICP, including results from the cluster-randomized trial, provide examples of real-world implementation of this program, and highlight ongoing challenges and barriers that are preventing widespread adoption of this intervention into routine practice. For the SICP to be successfully embedded into routine patient care, it will require significant effort, including ongoing leadership support and training opportunities, champions from all sectors of the interdisciplinary team, and adaptation of the program to a wider range of patients. Future research should also investigate how early conversations can be translated into personalized care plans for patients.
Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. [2023]Older patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) experience intense inpatient health care at the end-of-life stage. Early advance care planning may improve care at the end of life for patients with AML or MDS. The Serious Illness Care Program (SICP) is a multicomponent, communication intervention developed to improve conversations about values for patients with serious illnesses. The SICP has been shown to improve the quality and frequency of advance care planning discussions. We adapted the SICP for delivery via telehealth to older patients with AML or MDS. We conducted a single-center qualitative study of 45 participants (25 clinicians, 15 older patients with AML or MDS, and 5 caregivers). Participants, whether clinicians, patients, or caregivers, agreed that the SICP would help older patients with AML or MDS to share their personal values with their care team. Four qualitative themes emerged from our data: (1) serious illness conversations can be conducted via telehealth, (2) older patients have limited experience using technology but are willing and able to learn, (3) patients feel that serious illness conversations will help them understand their AML or MDS diagnosis and prognosis better, and (4) serious illness conversations should be common and routine, not extraordinary. The adapted SICP may provide older patients with AML or MDS an opportunity to share what matters most to them with their care team and may assist oncologists in aligning patient care with patient values. The adapted SICP is the subject of an ongoing single-arm pilot study at the Wilmot Cancer Institute (clinicaltrials.gov identifier: NCT04745676).
Lessons Learned from a Multi-Site, Team-Based Serious Illness Care Program Implementation at an Academic Medical Center. [2023]Background: Patients with serious illness benefit from conversations to share prognosis and explore goals and values. To address this, we implemented Ariadne Labs' Serious Illness Care Program (SICP) at Stanford Health Care. Objective: Improve quantity, timing, and quality of serious illness conversations. Methods: Initial implementation followed Ariadne Labs' SICP framework. We later incorporated a team-based approach that included nonphysician care team members. Outcomes included number of patients with documented conversations according to clinician role and practice location. Machine learning algorithms were used in some settings to identify eligible patients. Results: Ambulatory oncology and hospital medicine were our largest implementation sites, engaging 4707 and 642 unique patients in conversations, respectively. Clinicians across eight disciplines engaged in these conversations. Identified barriers that included leadership engagement, complex workflows, and patient identification. Conclusion: Several factors contributed to successful SICP implementation across clinical sites: innovative clinical workflows, machine learning based predictive algorithms, and nonphysician care team member engagement.