Palliative CareNCT05806255
Implementation of RELIEF for Patients With Palliative Care Needs
A study testing The RELIEF App in people with Palliative Care, run by William Osler Health System.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palliative Care
- What is being tested?
- The RELIEF App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Moderate to severe confusion due to delirium or dementia as determined by the patient's healthcare provider
- A patient with low technology literacy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- The RELIEF App
- Keywords
- palliative care, end of life care, e-health tool, implementation science, home care, virtual care, remote monitoring, symptom reporting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The RELIEF AppDevice
Also called RELIEF
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: The RELIEF App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily symptom self-report completed.
The percentages of patient who completed questionnaires.
Measured: Up to 6 months across implementation.
Site adoption.
The number of sites who have implemented RELIEF.
Measured: Immediately after the intervention.
Improved palliative care access.
The percentage of participating patients who actually enrolled in RELIEF study. Descriptive statistics will be used.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention.
Sustainability: RELIEF is seen to be sustainable post-study.
CFIR interviews will be used.
Measured: 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.
How many time patients used the RELIEF App.
Measured: 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.
A linear mixed model will be used to assess repeating distress scores.
Measured: Up to 6 months across implementation.
Patient preferences will be measured through the Medical Maximizer-Minimizer Scale (MMS).
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.
Measured: 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.
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.
Measured: Up to 6 months across implementation.
Satisfaction: Patients and healthcare providers are satisfied with using RELIEF for remote symptom monitoring.
Two month check-in and debrief surveys (2 months into the study and at the end of the study).
Measured: 2 months following implementation and immediately afterward.
High Patient Engagement: Patients are engaged with RELIEF.
Engagement will be measured by the time patients spend on their scheduled self-assessments, or lack of time spent.
Measured: 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.
End of study surveys will be employed.
Measured: 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.
Check in and debrief (at the end of the study) surveys will be used.
Measured: 2 months following implementation and immediately after data collection.
Improved palliative patient management.
Time between 1st email indicating alert, and 2nd email indicating alert was acknowledged (how quickly alerts were responded by healthcare providers).
Measured: 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.
Number of patients that are being followed up by a single healthcare provider.
Measured: Immediately after the intervention.
Reduced tertiary healthcare utilization and increased healthcare cost avoidance as a result of using RELIEF.
Number of visits to the emergency department and associated costs, compared to matched cohort.
Measured: Up to 6 months across implementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Osler Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Humber River Hospital, The Ottawa Hospital, Bruyère Health Research Institute., University of Ottawa, Ottawa Hospital Research Institute, University of Toronto, Queen's University, McMaster University
- Responsible party
- Sponsor
- Investigators
- Martin R Chasen, MBChB, MPhil, Principal investigator, William Osler Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806255
- Sponsor's protocol ID
- 3525
- Status last verified
- Dec 2023
- First submitted
- 3 Mar 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanuseputro P, Beach S, Chalifoux M, Wodchis WP, Hsu AT, Seow H, Manuel DG. Associations between physician home visits for the dying and place of death: A population-based retrospective cohort study. PLoS One. 2018 Feb 15;13(2):e0191322. doi: 10.1371/journal.pone.0191322. eCollection 2018.
PubMed 29447291Mooney K, Berry DL, Whisenant M, Sjoberg D. Improving Cancer Care Through the Patient Experience: How to Use Patient-Reported Outcomes in Clinical Practice. Am Soc Clin Oncol Educ Book. 2017;37:695-704. doi: 10.1200/EDBK_175418.
PubMed 28561689Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
PubMed 26644527Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
PubMed 28586821Tanuseputro P, Wodchis WP, Fowler R, Walker P, Bai YQ, Bronskill SE, Manuel D. The health care cost of dying: a population-based retrospective cohort study of the last year of life in Ontario, Canada. PLoS One. 2015 Mar 26;10(3):e0121759. doi: 10.1371/journal.pone.0121759. eCollection 2015.
PubMed 25811195Walker H, Anderson M, Farahati F, Howell D, Librach SL, Husain A, Sussman J, Viola R, Sutradhar R, Barbera L. Resource use and costs of end-of-Life/palliative care: Ontario adult cancer patients dying during 2002 and 2003. J Palliat Care. 2011 Summer;27(2):79-88.
PubMed 21805942Bhargava R, Keating B, Isenberg SR, Subramaniam S, Wegier P, Chasen M. RELIEF: A Digital Health Tool for the Remote Self-Reporting of Symptoms in Patients with Cancer to Address Palliative Care Needs and Minimize Emergency Department Visits. Curr Oncol. 2021 Oct 21;28(6):4273-4280. doi: 10.3390/curroncol28060363.
PubMed 34898539Isenberg SR, Tanuseputro P, Spruin S, Seow H, Goldman R, Thavorn K, Hsu AT. Cost-effectiveness of Investment in End-of-Life Home Care to Enable Death in Community Settings. Med Care. 2020 Aug;58(8):665-673. doi: 10.1097/MLR.0000000000001320.
PubMed 32520768Isenberg SR, Meaney C, May P, Tanuseputro P, Quinn K, Qureshi D, Saunders S, Webber C, Seow H, Downar J, Smith TJ, Husain A, Lawlor PG, Fowler R, Lachance J, McGrail K, Hsu AT. The association between varying levels of palliative care involvement on costs during terminal hospitalizations in Canada from 2012 to 2015. BMC Health Serv Res. 2021 Apr 13;21(1):331. doi: 10.1186/s12913-021-06335-1.
PubMed 33849539Isenberg SR, Lu C, McQuade J, Chan KKW, Gill N, Cardamone M, Torto D, Langbaum T, Razzak R, Smith TJ. Impact of a New Palliative Care Program on Health System Finances: An Analysis of the Palliative Care Program Inpatient Unit and Consultations at Johns Hopkins Medical Institutions. J Oncol Pract. 2017 May;13(5):e421-e430. doi: 10.1200/JOP.2016.014860. Epub 2017 Feb 28.
PubMed 28245147Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1.
PubMed 31538028Watanabe SM, Nekolaichuk C, Beaumont C, Johnson L, Myers J, Strasser F. A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J Pain Symptom Manage. 2011 Feb;41(2):456-68. doi: 10.1016/j.jpainsymman.2010.04.020. Epub 2010 Sep 15.
PubMed 20832987Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Anderson F, Downing GM, Hill J, Casorso L, Lerch N. Palliative performance scale (PPS): a new tool. J Palliat Care. 1996 Spring;12(1):5-11.
PubMed 8857241Jang RW, Caraiscos VB, Swami N, Banerjee S, Mak E, Kaya E, Rodin G, Bryson J, Ridley JZ, Le LW, Zimmermann C. Simple prognostic model for patients with advanced cancer based on performance status. J Oncol Pract. 2014 Sep;10(5):e335-41. doi: 10.1200/JOP.2014.001457. Epub 2014 Aug 12.
PubMed 25118208
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Self-Reporting of Symptoms by Patients With Palliative Care Needs (RELIEF): A Mixed-Methods Implementation Study
- ClinicalTrials.gov ID
- NCT05806255
- Acronym / sponsor ID
- 3525
- Conditions
- Palliative Care
- Keywords
- palliative care, end of life care, e-health tool, implementation science, home care, virtual care, remote monitoring, symptom reporting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- William Osler Health SystemUniversity, hospital or other
- Collaborators
- Humber River Hospital, The Ottawa Hospital, Bruyère Health Research Institute., University of Ottawa, Ottawa Hospital Research Institute, University of Toronto, Queen's University, McMaster University
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RELIEF Intervention Group | Experimental | Device: The RELIEF AppThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Moderate to severe confusion due to delirium or dementia as determined by the patient's healthcare provider
- A patient with low technology literacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The RELIEF AppAlso: RELIEFRELIEF 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. | Device | RELIEF Intervention Group |
Primary outcome
Daily symptom self-report completed.
Time frame: Up to 6 months across implementation.
The percentages of patient who completed questionnaires.
Site adoption.
Time frame: Immediately after the intervention.
The number of sites who have implemented RELIEF.
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.
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.
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.
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.
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.
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.
Sustainability: RELIEF is seen to be sustainable post-study.
Time frame: Immediately after the intervention.
CFIR interviews will be used.
11 secondary outcomes
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.
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.
Patient preferences will be measured through the Medical Maximizer-Minimizer Scale (MMS).
Time frame: 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.
Satisfaction: Patients and healthcare providers are satisfied with using RELIEF for remote symptom monitoring.
Time frame: 2 months following implementation and immediately afterward.
High Patient Engagement: Patients are engaged with RELIEF.
Time frame: 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.
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.
Improved palliative patient management.
Time frame: 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.
Reduced tertiary healthcare utilization and increased healthcare cost avoidance as a result of using RELIEF.
Time frame: Up to 6 months across implementation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 29447291Tanuseputro P, Beach S, Chalifoux M, Wodchis WP, Hsu AT, Seow H, Manuel DG. Associations between physician home visits for the dying and place of death: A population-based retrospective cohort study. PLoS One. 2018 Feb 15;13(2):e0191322. doi: 10.1371/journal.pone.0191322. eCollection 2018.
- Background: PubMed 28561689Mooney K, Berry DL, Whisenant M, Sjoberg D. Improving Cancer Care Through the Patient Experience: How to Use Patient-Reported Outcomes in Clinical Practice. Am Soc Clin Oncol Educ Book. 2017;37:695-704. doi: 10.1200/EDBK_175418.
- Background: PubMed 26644527Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
- Background: PubMed 28586821Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
- Background: PubMed 25811195Tanuseputro P, Wodchis WP, Fowler R, Walker P, Bai YQ, Bronskill SE, Manuel D. The health care cost of dying: a population-based retrospective cohort study of the last year of life in Ontario, Canada. PLoS One. 2015 Mar 26;10(3):e0121759. doi: 10.1371/journal.pone.0121759. eCollection 2015.
- Background: PubMed 21805942Walker H, Anderson M, Farahati F, Howell D, Librach SL, Husain A, Sussman J, Viola R, Sutradhar R, Barbera L. Resource use and costs of end-of-Life/palliative care: Ontario adult cancer patients dying during 2002 and 2003. J Palliat Care. 2011 Summer;27(2):79-88.
- Background: PubMed 34898539Bhargava R, Keating B, Isenberg SR, Subramaniam S, Wegier P, Chasen M. RELIEF: A Digital Health Tool for the Remote Self-Reporting of Symptoms in Patients with Cancer to Address Palliative Care Needs and Minimize Emergency Department Visits. Curr Oncol. 2021 Oct 21;28(6):4273-4280. doi: 10.3390/curroncol28060363.
- Background: PubMed 32520768Isenberg SR, Tanuseputro P, Spruin S, Seow H, Goldman R, Thavorn K, Hsu AT. Cost-effectiveness of Investment in End-of-Life Home Care to Enable Death in Community Settings. Med Care. 2020 Aug;58(8):665-673. doi: 10.1097/MLR.0000000000001320.
- Background: PubMed 33849539Isenberg SR, Meaney C, May P, Tanuseputro P, Quinn K, Qureshi D, Saunders S, Webber C, Seow H, Downar J, Smith TJ, Husain A, Lawlor PG, Fowler R, Lachance J, McGrail K, Hsu AT. The association between varying levels of palliative care involvement on costs during terminal hospitalizations in Canada from 2012 to 2015. BMC Health Serv Res. 2021 Apr 13;21(1):331. doi: 10.1186/s12913-021-06335-1.
- Background: PubMed 28245147Isenberg SR, Lu C, McQuade J, Chan KKW, Gill N, Cardamone M, Torto D, Langbaum T, Razzak R, Smith TJ. Impact of a New Palliative Care Program on Health System Finances: An Analysis of the Palliative Care Program Inpatient Unit and Consultations at Johns Hopkins Medical Institutions. J Oncol Pract. 2017 May;13(5):e421-e430. doi: 10.1200/JOP.2016.014860. Epub 2017 Feb 28.
- Background: PubMed 31538028Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1.
- Background: PubMed 20832987Watanabe SM, Nekolaichuk C, Beaumont C, Johnson L, Myers J, Strasser F. A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J Pain Symptom Manage. 2011 Feb;41(2):456-68. doi: 10.1016/j.jpainsymman.2010.04.020. Epub 2010 Sep 15.
- Questions \& Answers (Q\&A), Instructions \& Definitions for Use of Palliative Performance ScaleLink provided by the sponsor.
- The Golds Standard FrameworkLink provided by the sponsor.
- Phase 1 site assessments will be informed by the Hexagon Tool, a framework that assesses the fit and feasibility for organizations to implement an interventionLink provided by the sponsor.
- Platform where online surveys will be completedLink provided by the sponsor.
- Phase 3 CFIR interviews informed by these guidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Palliative Care
Not yet recruitingPhase 1/2
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Intractable Pain, Palliative Care
Not yet recruiting
Integrating Rhythmical Massage in Palliative Care
Palliative Care, Health Services, Palliative Care
Recruiting
SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care
Palliative Care, Serious Games
RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
Cancer, Palliative Care, Patient Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin R Chasen, MBChB, MPhil principal investigator
William Osler Health System
Questions about this trial
What is this clinical trial studying?
A study testing The RELIEF App in people with Palliative Care, run by William Osler Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin R Chasen, MBChB, MPhil (905-494-2120 ext. 57342, Martin.Chasen@williamoslerhs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily symptom self-report completed. (time frame: Up to 6 months across implementation.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05806255, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.