Implementation of RELIEF for Patients With Palliative Care Needs

December 4, 2023 updated by: William Osler Health System

Remote Self-Reporting of Symptoms by Patients With Palliative Care Needs (RELIEF): A Mixed-Methods Implementation Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RELIEF Intervention Group

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

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.

Other Names:
  • RELIEF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily symptom self-report completed.
Time Frame: Up to 6 months across implementation.
The percentages of patient who completed questionnaires.
Up to 6 months across implementation.
Site adoption.
Time Frame: Immediately after the intervention.
The number of sites who have implemented RELIEF.
Immediately after the intervention.
Improved palliative care access.
Time Frame: Immediately after the intervention.
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.
Time Frame: Up to 6 months across implementation.
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.
Time Frame: Up to 6 months across implementation.
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.
Time Frame: Up to 6 months across implementation.
CFIR interviews.
Up to 6 months across implementation.
Fidelity.
Time Frame: Immediately after the intervention.
RELIEF was implemented as intended, measured by whether the patients had their symptoms addressed by a healthcare provider.
Immediately after the intervention.
Penetration.
Time Frame: Immediately after the intervention.
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.
Time Frame: Immediately after the intervention.
CFIR interviews will be used.
Immediately after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Participation: patients become active participants in their health monitoring and self-care through regular remote self-reporting of symptoms via RELIEF.
Time Frame: Up to 6 months across implementation.
How many time patients used the RELIEF App.
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.
Time Frame: Up to 6 months across implementation.
A linear mixed model will be used to assess repeating distress scores.
Up to 6 months across implementation.
Patient preferences will be measured through the Medical Maximizer-Minimizer Scale (MMS).
Time Frame: Immediately after the intervention.
This scale assesses patient preferences for active vs. passive approaches to healthcare and predicts healthcare. It consists of 10 statements and identified 3 patient groups - minimizers, moderate maximizers and strong maximizers. Medical maximizers (people scoring highly on the MMS) prefer to receive more health care visits, medications, tests, and treatments, whereas minimizers prefer fewer services.
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.
Time Frame: Up to 6 months across implementation.

Measured via comparing the ratio of unnecessary to actual number of emergency department visits during the intervention period compared to a matched cohort.

Unnecessary preventable visits were defined as: (1) Conditions for which exacerbations that result in hospital use suggest lack of access to adequate primary care, (2) Low-acuity visits, triaged as non-urgent at ED registration.
Up to 6 months across implementation.
Satisfaction: Patients and healthcare providers are satisfied with using RELIEF for remote symptom monitoring.
Time Frame: 2 months following implementation and immediately afterward.
Two month check-in and debrief surveys (2 months into the study and at the end of the study).
2 months following implementation and immediately afterward.
High Patient Engagement: Patients are engaged with RELIEF.
Time Frame: Up to 6 months across implementation.
Engagement will be measured by the time patients spend on their scheduled self-assessments, or lack of time spent.
Up to 6 months across implementation.
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.
Time Frame: 2 months following end of data collection.
End of study surveys will be employed.
2 months following end of data collection.
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.
Time Frame: 2 months following implementation and immediately after data collection.
Check in and debrief (at the end of the study) surveys will be used.
2 months following implementation and immediately after data collection.
Improved palliative patient management.
Time Frame: Up to 6 months across implementation.
Time between 1st email indicating alert, and 2nd email indicating alert was acknowledged (how quickly alerts were responded by healthcare providers).
Up to 6 months across implementation.
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.
Time Frame: Immediately after the intervention.
Number of patients that are being followed up by a single healthcare provider.
Immediately after the intervention.
Reduced tertiary healthcare utilization and increased healthcare cost avoidance as a result of using RELIEF.
Time Frame: Up to 6 months across implementation.
Number of visits to the emergency department and associated costs, compared to matched cohort.
Up to 6 months across implementation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Osler Health System

Collaborators

McMaster University
University of Toronto
Ottawa Hospital Research Institute
The Ottawa Hospital
University of Ottawa
Queen's University
Humber River Hospital
Bruyere Research Institute

Investigators

  • Principal Investigator: Martin R Chasen, MBChB, MPhil, William Osler Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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