Clinical trial NCT05806255: Implementation of RELIEF for Patients With Palliative Care Needs
Official title: Remote Self-Reporting of Symptoms by Patients With Palliative Care Needs (RELIEF): A Mixed-Methods Implementation Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Palliative Care
Keywords: palliative care
end of life care
e-health tool
implementation science
home care
virtual care
remote monitoring
symptom reporting
Lead sponsor: William Osler Health System
Sponsor class: OTHER
Collaborators: name: Humber River Hospital
name: The Ottawa Hospital
name: Bruyere Research Institute
name: University of Ottawa
name: Ottawa Hospital Research Institute
name: University of Toronto
name: Queen's University
name: McMaster University
First posted: 2023-04-10
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: For patients with palliative care needs, access to care is constrained by health system resources and a requirement to visit their clinician for assessments. As assessments typically only occur every 4-8 weeks, this results in emergency department visits by patients/caregivers. More frequent assessments would provide more timely and earlier interventions for patients by their clinicians should intervention be required. However, a key barrier to effective symptom management and patient/family comfort is the lack of real-time symptom status.

RELIEF allows for the remote self-reporting of symptoms by patients to their healthcare providers. It is an easy and effective method of remote symptom reporting for patients with palliative care needs, and RELIEF has the potential to result in significant healthcare cost avoidance and improved patient care. The proposed study will establish the feasibility of implementing RELIEF across a diverse set of populations and settings in Canada.

Detailed description: Over 90% of Canadians agree patients have the right to receive care in their own homes at the end of life and over half of Canadians expect the bulk of their end-of-life care to occur in their own homes. A primary challenge to achieving these outcomes is insufficient resources and services around symptom assessment, monitoring, and management. Poor symptom monitoring in the home and late referrals for symptom management may account for many patients dying in hospitals-nearly 65% of patients in Ontario died in hospitals in 2015/16. Receipt of palliative care services in the home has been associated with a 47% reduction in the likelihood of dying while in hospital. Additionally, costs to the healthcare system are substantially higher in hospitalized patients.

Studies have demonstrated how remote monitoring of symptoms can improve care in patients with palliative care needs. However, some existing digital solutions are limited in that they are rarely well-integrated into the workflow. Additionally, alerting mechanisms to trigger interventions are often absent and the target populations tend to only focus on patients with cancer. Therefore, RELIEF was introduced as an online application designed for the remote self-reporting of symptoms in all patients with palliative care needs. The patient/caregiver securely logs into the site and self-reports symptoms, distress, and pain using validated clinical tools. Results are reported to the patient's healthcare team and flares in symptom burden are flagged for clinical review. These frequent assessments allow for: (1) earlier intervention; (2) mobilization of auxiliary services; and (3) recommendation for emergency or palliative intake. Clinicians and nursing staff access patients' data through RELIEF and receive alerts for any sudden, unexpected, and large changes in symptom status, allowing for timely acute interventions or close passive monitoring, reducing patient stress through the knowledge that their healthcare provider is monitoring their symptoms.

In a small pilot study of RELIEF in just 20 patients, it was found that the patient compliance rate was \>80%, with 92% of clinicians reporting improved confidence in the care provided, and an estimated healthcare cost avoidance of over $20,000 per patient over several months was achieved.

Eligibility criteria: Inclusion Criteria:

1. Patient has palliative care needs
2. Any life-limiting diagnosis (including non-cancer diagnoses)
3. Score of 40% or above on the Palliative Performance Scale
4. Able to communicate in English or French
5. Have access to the internet
6. Are comfortable learning to use RELIEF for remote symptom self-reporting OR have a caregiver who is comfortable learning to use RELIEF and regularly reporting the patient's symptoms

Exclusion Criteria:

1. Moderate to severe confusion due to delirium or dementia as determined by the patient's healthcare provider
2. A patient with low technology literacy

Primary outcomes:
measure: Daily symptom self-report completed.
timeFrame: Up to 6 months across implementation.
measure: Site adoption.
timeFrame: Immediately after the intervention.
measure: Improved palliative care access.
timeFrame: Immediately after the intervention.
measure: Acceptability: Partner sites perceive RELIEF to be agreeable, palatable, and/or satisfactory.
timeFrame: Up to 6 months across implementation.
measure: Individual Adoption: Individual healthcare providers take clinically appropriate action.
timeFrame: Up to 6 months across implementation.
measure: Appropriateness: RELIEF is seen to fit, be relevant for, or be compatible across a wide variety of settings in Canada.
timeFrame: Up to 6 months across implementation.
measure: Fidelity.
timeFrame: Immediately after the intervention.
measure: Penetration.
timeFrame: Immediately after the intervention.
measure: Sustainability: RELIEF is seen to be sustainable post-study.
timeFrame: Immediately after the intervention.
Secondary outcomes:
measure: Active Participation: patients become active participants in their health monitoring and self-care through regular remote self-reporting of symptoms via RELIEF.
timeFrame: Up to 6 months across implementation.
measure: Distress: Patients and their families experience less worry and concern knowing that their symptoms are being followed up by their clinical team and have access to professional opinions and treatment by their team.
timeFrame: Up to 6 months across implementation.
measure: Patient preferences will be measured through the Medical Maximizer-Minimizer Scale (MMS).
timeFrame: Immediately after the intervention.
measure: Guided Transitions: Patients avoid unnecessary trips to the emergency department for acute symptom burden through the clinical intervention made possible by RELIEF.
timeFrame: Up to 6 months across implementation.
measure: Satisfaction: Patients and healthcare providers are satisfied with using RELIEF for remote symptom monitoring.
timeFrame: 2 months following implementation and immediately afterward.
measure: High Patient Engagement: Patients are engaged with RELIEF.
timeFrame: Up to 6 months across implementation.
measure: Navigation: Patients experience more seamless navigation through the healthcare system as RELIEF allows them to easily remotely self-report their symptoms and receive clinical intervention if appropriate.
timeFrame: 2 months following end of data collection.
measure: Connectedness to healthcare team. Patients feel a sense of connection with their healthcare team, which will provide comfort in knowing the team is there for them.
timeFrame: 2 months following implementation and immediately after data collection.
measure: Improved palliative patient management.
timeFrame: Up to 6 months across implementation.
measure: Increase healthcare system capacity - RELIEF allows a single healthcare provider to oversee and follow up with a greater number of patients by improved allocation of health care resources.
timeFrame: Immediately after the intervention.
measure: Reduced tertiary healthcare utilization and increased healthcare cost avoidance as a result of using RELIEF.
timeFrame: Up to 6 months across implementation.
Other outcomes:
Locations:
Study officials:
affiliation: William Osler Health System
name: Martin R Chasen, MBChB, MPhil
role: PRINCIPAL_INVESTIGATOR
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