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Implementation of RELIEF for Patients With Palliative Care Needs

Sponsor
William Osler Health System (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05806255
Collaborator
Humber River Hospital (Other), The Ottawa Hospital (Other), Bruyere Research Institute (Other), University of Ottawa (Other), Ottawa Hospital Research Institute (Other), University of Toronto (Other), Queen's University (Other), McMaster University (Other)
600
Enrollment
1
Arm
28
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The RELIEF App
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Remote Self-Reporting of Symptoms by Patients With Palliative Care Needs (RELIEF): A Mixed-Methods Implementation Study
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

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: Home and Community Care Support Services Central West Home and Community Care Support Services Central Home and Community Care Support Services Champlain Home and Community Care Support Services North East Curve Lake First Nation (CLFN) 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Daily symptom self-report completed. [Up to 6 months across implementation.]

      The percentages of patient who completed questionnaires.

    2. Site adoption. [Immediately after the intervention.]

      The number of sites who have implemented RELIEF.

    3. Improved palliative care access. [Immediately after the intervention.]

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

    4. Acceptability: Partner sites perceive RELIEF to be agreeable, palatable, and/or satisfactory. [Up to 6 months across implementation.]

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

    5. Individual Adoption: Individual healthcare providers take clinically appropriate action. [Up to 6 months across implementation.]

      Proportion of response by healthcare providers to the RELIEF alerts.

    6. Appropriateness: RELIEF is seen to fit, be relevant for, or be compatible across a wide variety of settings in Canada. [Up to 6 months across implementation.]

      CFIR interviews.

    7. Fidelity. [Immediately after the intervention.]

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

    8. Penetration. [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.

    9. Sustainability: RELIEF is seen to be sustainable post-study. [Immediately after the intervention.]

      CFIR interviews will be used.

    Secondary Outcome Measures

    1. 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.]

      How many time patients used the RELIEF App.

    2. 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.]

      A linear mixed model will be used to assess repeating distress scores.

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

    4. 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.]

      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.

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

    6. High Patient Engagement: Patients are engaged with RELIEF. [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.

    7. 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. [2 months following end of data collection.]

      End of study surveys will be employed.

    8. 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. [2 months following implementation and immediately after data collection.]

      Check in and debrief (at the end of the study) surveys will be used.

    9. Improved palliative patient management. [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).

    10. 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. [Immediately after the intervention.]

      Number of patients that are being followed up by a single healthcare provider.

    11. Reduced tertiary healthcare utilization and increased healthcare cost avoidance as a result of using RELIEF. [Up to 6 months across implementation.]

      Number of visits to the emergency department and associated costs, compared to matched cohort.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • William Osler Health System
    • Humber River Hospital
    • The Ottawa Hospital
    • Bruyere Research Institute
    • University of Ottawa
    • Ottawa Hospital Research Institute
    • University of Toronto
    • Queen's University
    • McMaster University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    William Osler Health System
    ClinicalTrials.gov Identifier:
    NCT05806255
    Other Study ID Numbers:
    • 3525
    First Posted:
    Apr 10, 2023
    Last Update Posted:
    Apr 10, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by William Osler Health System
    palliative care
    end of life care
    e-health tool
    implementation science
    home care
    virtual care
    remote monitoring
    symptom reporting

    Study Results

    No Results Posted as of Apr 10, 2023