Implementing REmote SymPtom mOnitoring and maNagement (RESPONd)

Официальное название

Implementing REmote SymPtom mOnitoring and maNagement (RESPONd): Evaluating the Impact on Cancer Patients, System Efficiency, and Economic Outcomes

Обзор

The goal of this study is to understand if the implementation of a remote symptom monitoring and management program improves outcomes. The program will provide patients the opportunity to complete electronic Patient Reported Outcomes (PROs) questionnaires from home between appointments and receive tailored advice from a study nurse. A second goal of this study is to examine the impact of electronic symptom monitoring on clinic efficiencies. The main question it aims to answer is: • What impact does implementing digitally enabled remote symptom monitoring and management (RESPONd) between ambulatory oncology visits have on patient outcomes and system efficiencies? Participants will: * Report their symptoms and concerns from home by completing the electronic symptom monitoring questionnaire. * Discuss their symptoms and concerns with a study nurse. * Provide feedback about their experience at important timepoints during the study. * Participate as usual in ambulatory clinic appointments.

Подробное описание

Rationale:

In recent years, cancer care has increasingly shifted from acute to ambulatory settings as a strategy to manage healthcare costs. While some emergency department (ED) visits are unavoidable due to the complexity of cancer-related issues, many could be prevented through timely symptom management and coordinated care in ambulatory oncology. The integration of Patient Reported Outcomes (PROs) into routine cancer care has been shown to reduce ED visits, enhance quality of life, and improve overall survival.

Within Cancer Care Alberta, PROs are routinely collected during clinic visits and electronically, using a standardized questionnaire that assesses common symptoms and supportive care needs experienced by cancer patients. Despite this, the use of electronic PROs data for real-time symptom management remains inconsistent, and there is currently no established workflow in Alberta for remote symptom monitoring. As a result, healthcare providers often lack advance insight into patients' symptoms prior to appointments.

Study Design:

The study is a stepped-wedge effectiveness-implementation type 1 hybrid design. RESPONd will be implemented over 1.5 years in six clinics, spanning tertiary, regional, and community cancer centres. Study nurses will monitor electronic PROs questionnaires completed between clinic visits and contact patients to provide personalized support. Collected electronic PROs information will also be utilized during weekly triage discussions in each clinic, where the route of care will be tailored for patients based on their symptom complexity. Participant quality of life will be measured at baseline, 3, and 6 months. Health care utilization compared to non-RESPONd patients will be evaluated. The implementation of this study will be evaluated using the RE-AIM framework, utilizing all constructs.

Following completion of the quantitative phase (stepped-wedge effectiveness-implementation type 1 hybrid design), a qualitative component will be conducted using semi-structured interviews with a subset of participants. This phase aims to explain and provide deeper insight into the quantitative results, including patient experiences, contextual factors influencing implementation, and perceived barriers and facilitators to intervention uptake.

Potential impact on practice:

The study will explore a person-centered, proactive approach to remote symptom management and the effects on patient experience, outcomes, and clinical teams. RESPONd represents an innovative opportunity to shift the model of care in oncology clinics to optimize efficiency and utilization of limited clinic resources and create a responsive care team that is ready and able to provide personalized symptom management and supportive care within the cancer journey.

Вмешательства

• Другое Remote Symptom Monitoring and Management
  A study nurse will digitally monitor symptom complexity and provide symptom management between clinic visits. This will increase the frequency of collection and use of electronic PROs to provide responsive symptom management. Electronic PROs are collected digitally, and a complexity algorithm is used to flag patients with high symptom complexity. This will allow the study nurse to proactively manage symptoms in a timelier way.
• Другое Clinic Team Huddle
  Support will be provided to clinic teams to implement a team huddle (team planning session) one week prior to clinics, to assess how additional electronic PROs data for patients participating in RESPONd impacts their ability to identify stable patients with low symptom complexity who could receive virtual care or Registered Nurse (RN) led clinic care.

Первичные конечные точки

• Quality of Life (QoL) [Срок оценки: Baseline, 3 months and 6 months]
• Self-rated health [Срок оценки: Baseline, 3 months and 6 months]
• Rate of Emergency department (ED) visits [Срок оценки: Baseline through study completion, an average of 18 months]
• Rate of Hospital admissions [Срок оценки: Baseline through study completion, an average of 18 months]
• Economic outcome measure - Incremental cost-effectiveness ratio (ICER) [Срок оценки: Baseline through study completion, an average of 18 months]
• Economic outcome measures - Quality adjusted life years (QUALYs) [Срок оценки: Baseline through study completion, an average of 18 months]

Вторичные конечные точки (5)

• Clinic outcome measure - Patient scheduling and clinic visit type [Срок оценки: Baseline through study completion, an average of 18 months]
• Clinic outcome measure - Number of patients that required additional intervention [Срок оценки: Baseline through study completion, an average of 18 months]
• Clinic outcome measure - Number of times the study nurse needed to contact the Medical Oncologist [Срок оценки: Baseline through study completion, an average of 18 months]
• Patient experience measure [Срок оценки: At baseline, and 6 months/end of the intervention]
• Staff experience measure [Срок оценки: Quarterly - from baseline through study completion, an average of 18 months]

Критерии участия

Критерии включения

• Age ≥ 18
• Have cancer
• Receiving care in one of the participating clinics.
• Able to sign up for MyAHS Connect and consent.
• Have access to a digital device at home
• Able to complete their electronic PROs questionnaire without support from the clinic team on a weekly (patients on active treatment) or monthly (patients on follow-up) basis, for the duration of the intervention or until they are discharged from the clinic.
• Regular access to a telephone in order for the study nurse to call patients to provide symptom management support.

Критерии исключения

• Patients with cognitive disabilities or who cannot reliably report symptoms independently.
• Patients not residing in Alberta, as government-issued ID is required to register for MyAHS Connect.
• Patients who do not have regular access to a telephone, as the study nurse needs to be able to call patients to provide symptom management support.
• Patients who do not speak English, or who do not have an English-speaking friend, family member, or caregiver to assist them, as the electronic PROs questionnaire is only available in English at this time.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 4 центра

• Arthur J. E. Child Comprehensive Cancer Centre — Calgary
• Cross Cancer Institute — Edmonton
• High River Community Cancer Centre — High River
• Central Alberta Cancer Centre — Red Deer

Публикации

• Watson L, Qi S, Link C, DeIure A, Afzal A, Barbera L. Patient-Reported Symptom Complexity and Acute Care Utilization Among Patients With Cancer: A Population-Based Study Using a Novel Symptom Complexity Algorithm and Observational Data. J Natl Compr Canc Netw. 2023 Feb;21(2):173-180. doi: 10.6004/jnccn.2022.7087. PMID 36791760

Идентификаторы

NCT: NCT07024329 · HREBA.CC-24-0138

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗