Implementation of RELIEF for Patients With Palliative Care Needs

NCT05806255 | Unknown

• 1 other identifier: 3525
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Palliative Care

Keywords

palliative care; end of life care; e-health tool; implementation science; home care; virtual care; remote monitoring; symptom reporting

Outcome Measures

Primary Outcomes (9)

• Daily symptom self-report completed.

  The percentages of patient who completed questionnaires.

  Up to 6 months across implementation.

• Site adoption.

  The number of sites who have implemented RELIEF.

  Immediately after the intervention.

• Improved palliative care access.

  The percentage of participating patients who actually enrolled in RELIEF study. Descriptive statistics will be used.

  Immediately after the intervention.

• Acceptability: Partner sites perceive RELIEF to be agreeable, palatable, and/or satisfactory.

  CFIR interviews and Hexagon Tool will be used and analyzed qualitatively for emerging themes.

  Up to 6 months across implementation.

• Individual Adoption: Individual healthcare providers take clinically appropriate action.

  Proportion of response by healthcare providers to the RELIEF alerts.

  Up to 6 months across implementation.

• Appropriateness: RELIEF is seen to fit, be relevant for, or be compatible across a wide variety of settings in Canada.

  CFIR interviews.

  Up to 6 months across implementation.

• Fidelity.

  RELIEF was implemented as intended, measured by whether the patients had their symptoms addressed by a healthcare provider.

  Immediately after the intervention.

• Penetration.

  Proportion of patients recruited to join RELIEF and proportion of healthcare providers participating in RELIEF at each of the sites will be assessed.

  Immediately after the intervention.

• Sustainability: RELIEF is seen to be sustainable post-study.

  CFIR interviews will be used.

  Immediately after the intervention.

Secondary Outcomes (11)

• Active Participation: patients become active participants in their health monitoring and self-care through regular remote self-reporting of symptoms via RELIEF.

  Up to 6 months across implementation.

• 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.

  Up to 6 months across implementation.

• Patient preferences will be measured through the Medical Maximizer-Minimizer Scale (MMS).

  Immediately after the intervention.

• Guided Transitions: Patients avoid unnecessary trips to the emergency department for acute symptom burden through the clinical intervention made possible by RELIEF.

  Up to 6 months across implementation.

• Satisfaction: Patients and healthcare providers are satisfied with using RELIEF for remote symptom monitoring.

  2 months following implementation and immediately afterward.

Study Arms (1)

RELIEF Intervention Group

EXPERIMENTAL

The RELIEF App will be implemented according to a standardized procedure at the six following sites, with 100 patients recruited at each site: 1. Home and Community Care Support Services Central West 2. Home and Community Care Support Services Central 3. Home and Community Care Support Services Champlain 4. Home and Community Care Support Services North East 5. Curve Lake First Nation (CLFN) 6. St. Mary's Hospital

Device: The RELIEF App

Interventions

The RELIEF App DEVICE

RELIEF is a virtual app designed for the remote self-reporting of symptoms in patients with palliative care needs. The patient/caregiver securely logs into the site and self-reports symptoms, distress, and pain using the validated clinical tools ESAS-r, Distress Thermometer (DT), and Brief Pain Inventory (BPI) currently in daily use by healthcare providers across Canada. This data is reported to the healthcare providers via RELIEF. Any increases in symptom burden, distress, or pain are flagged for clinical review as RELIEF alerts. Healthcare providers received alerts via secure email for any sudden changes in symptom status, or if the patient's symptoms, distress, or pain severity increases by set amounts over a period of time. Following review of the RELIEF alert by the healthcare providers, patients receive (1) earlier intervention; (2) mobilization of auxiliary services; and (3) recommendation for urgent clinic/home visit or emergency department visit.

Also known as: RELIEF

RELIEF Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has palliative care needs
• Any life-limiting diagnosis (including non-cancer diagnoses)
• Score of 40% or above on the Palliative Performance Scale
• Able to communicate in English or French
• Have access to the internet
• 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

You may not qualify if:

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

Sponsors & Collaborators

• William Osler Health System: lead
• Humber River Hospital: collaborator
• The Ottawa Hospital: collaborator
• Bruyère Health Research Institute.: collaborator
• University of Ottawa: collaborator
• Ottawa Hospital Research Institute: collaborator
• University of Toronto: collaborator
• Queen's University: collaborator
• McMaster University: collaborator

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Related Links

• Cancer Care Ontario Symptom Assessment Tools
• Questions \& Answers (Q\&A), Instructions \& Definitions for Use of Palliative Performance Scale
• The Golds Standard Framework
• Phase 1 site assessments will be informed by the Hexagon Tool, a framework that assesses the fit and feasibility for organizations to implement an intervention
• Platform where online surveys will be completed
• Phase 3 CFIR interviews informed by these guidelines

Study Officials

• Martin R Chasen, MBChB, MPhil

  William Osler Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin R Chasen, MBChB, MPhil

CONTACT

905-494-2120; Martin.Chasen@williamoslerhs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 10, 2023
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: October 31, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share