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Palliative TherapyHOMRNCT04171830

Clinical Surveillance Tool to Screen for Unmet Palliative Needs Among Patients in the Final Year of Life

A study testing modified Hospital One-year Mortality Risk (mHOMR) in people with Palliative Therapy and Implementation Science, run by Ottawa Hospital Research Institute at 13 sites in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

One of the most important obstacles to improving end-of-life care is the inability of clinicians to reliably identify those who are approaching the end-of-life. Every aspect of a palliative approach to care - screening for unmet needs, treating symptoms, discussing goals of care, and developing a palliative management… Read more about this study

Who is it for?
Any age
What is being tested?
modified Hospital One-year Mortality Risk (mHOMR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,536 participants
Where
13 sitesCanada
Study dates
17 Jun 2019to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • All newly admitted patients to selected medical units in participating sites during the 6-9-month intervention implementation period
  • [To be assessed for unmet palliative needs] the patient must be competent and have the ability to participate in assessments (i.e. answer assessment questions and understand and speak sufficient English to participate).

Who cannot join

  • N/A for mHOMR/HOMR-Now! intervention
  • For palliative needs assessments: incapability of completing the ESAS and 4-Item ACP tools, either because of capacity/cognitive impairment or English-language ability.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

13 sites in 1 country

Canada13 sites
  • William Osler Health System

    Brampton, Ontario, L6R37J

  • Cambridge Memorial Hospital

    Cambridge, Ontario, N1R3G2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L2V7

  • London Health Sciences Centre

    London, Ontario

  • Headwaters Health Care Centre

    Orangeville, Ontario, L9W4X9

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6

  • Montfort Hospital

    Ottawa, Ontario, K1K0T2

  • Queensway Carleton Hospital

    Ottawa, Ontario, K2H8P4

  • Pembroke Regional Hospital

    Pembroke, Ontario, K8A1G8

  • North York General Hospital

    Toronto, Ontario, M2K1E1

  • Humber River Hospital

    Toronto, Ontario, M3M0B2

  • Saint Michael's Hospital

    Toronto, Ontario, M5B1W8

  • Windsor Regional Hospital

    Windsor, Ontario, N8W1L9

Other trials in Canada

About this study

Official title: Use of an Automated Prospective Clinical Surveillance Tool to Drive Screening for Unmet Palliative Needs Among Patients in the Final Year of Life

One of the most important obstacles to improving end-of-life care is the inability of clinicians to reliably identify those who are approaching the end-of-life. Every aspect of a palliative approach to care - screening for unmet needs, treating symptoms, discussing goals of care, and developing a palliative management plan - depends on the reliable and accurate identification of patients with palliative needs. The investigators developed an accurate and reliable mortality prediction tool that automatically identifies patients in hospital at elevated risk of death in the coming year. In previous studies it has been shown that these patients also frequently have unmet palliative care needs at the time they are identified by the tool. This tool has been demonstrated feasible, acceptable to patients and providers, and effective for changing physician behaviour in an inpatient clinical context.

In this project, this tool is implemented as part of an integrated knowledge translation project to facilitate reliable and timely identification of unmet palliative needs across multiple hospitals with different clinical settings and contexts. The investigators have partnered with 12 hospitals to improve the quality of palliative and end-of-life care provided to patients and families. With each partner site the investigators will develop a comprehensive implementation plan, including stakeholder engagement, education, and feedback. Process measures will be collected at each site to determine whether the tool was effective for promoting the identification and documentation of unmet palliative needs. Patients who were identified by the tool will also be followed over time to collect outcome and impact measures to see if their end-of-life care was affected by the intervention compared to control groups.

Read the detailed description

Recently, van Walraven et al described the Hospital One-year Mortality Risk (HOMR) score for predicting 1-year mortality for patients admitted to hospital. HOMR is based on 12 administrative data points routinely coded by hospitals at the time of discharge and available in the CIHI Discharge Abstract Database. The model has been externally validated with excellent discrimination and calibration. Among HOMR's 12 data fields, nine are routinely available in the Electronic Health Record (EHR) at the time of admission in Ontario. Using a method similar to that used to derive HOMR, the investigators developed a "modified" HOMR (mHOMR) model based on the nine data fields available at the time of admission. mHOMR had comparable accuracy to HOMR (C-statistic .89 vs .92, respectively). Additionally, an updated version of mHOMR has recently been developed and validated, called HOMR Now!, which has the same c-statistic as the original HOMR (.92) but is calculated using ten data fields and an interaction available in many hospital admissions data, similar to mHOMR. Using either mHOMR or HOMR Now!, hospitals are able to retrieve admissions data from the EMR and calculate each patient's mortality risk on admission. If any patient's mortality risk exceeds a predefined threshold, the application would send a message to their clinical team prompting them to assess and address unmet palliative needs.

mHOMR has been implemented in four hospitals in Ontario to date and has been adapted to work with different EHRs. The mHOMR application identified a gender-balanced cohort of generally elderly patients (mean age of 83 years) who were admitted for several days (median length of stay of 5 days) and discharged alive (89%), meaning they were not in their final days of life and there would be an opportunity to screen for unmet needs and participate in care planning. A second pilot study found >90% of patients identified by the application had an unmet palliative need- either a severe symptom or a desire to discuss ACP with a physician or both-and that patients with higher mHOMR scores had more severe symptoms. The application preferentially identified patients with non-cancer illnesses-most were admitted with a frailty-related condition (56.8%), followed by end-stage organ failure (23.5%), and cancer (20%)-meaning that the tool did not show a bias towards cancer but instead identified patients who reflected the actual population of dying Canadians. These results are similar to findings from HOMR Now! validation work. Furthermore, investigators found <50% of those identified by mHOMR had a documented palliative care consultation or Goals of Care discussion, but after the integration of mHOMR notifications into existing workflow, the incidence of early Goals of Care discussions and palliative care consultation increased significantly. Additionally, qualitative results show the application is acceptable to patients and clinicians alike.

Both the mHOMR and HOMR Now! applications are intended to be a reliable and accurate "trigger" to improve the effectiveness of any palliative intervention by focusing attention on a small group of patients with a high risk of death and unmet palliative needs. Both applications can also be versatile depending on the situation-it produces a numerical risk output rather than a binary yes/no like the Surprise Question, Gold Standards Framework or NECPAL tools, so the user can decide what threshold to use for identifying "high risk" patients. Thus, organizations concerned with the efficient use of limited resources could set a higher mortality threshold, while organizations using more scalable interventions could lower the mortality threshold.

Given the initial success of the mHOMR and HOMR Now! applications in identifying unmet palliative care needs in an acceptable way among patients nearing the end-of-life, the next step is to implement and rigorously evaluate the immediate long-term effects of this highly scalable intervention in a large population to determine whether it improves screening and documentation processes and ultimately leads to better outcomes for patients, family members, and the healthcare system as a whole. To achieve this aim, investigators have partnered with twelve acute care hospitals from across Ontario to implement the mHOMR/HOMR-Now! intervention.

Objective

To determine whether implementation of an mHOMR or HOMR Now! application to identify patients at increased risk of death and trigger screening for unmet palliative needs improves (1) identification and documentation of those needs and (2) the end-of-life care provided to patients.

Intervention-Implementation Procedures

Every inpatient at each site will automatically be given the intervention (an mHOMR or HOMR Now! Score, depending on which application can be most easily integrated into each site's existing EMR system) upon admission to an implementing unit at a participating hospital and considered for secondary interventions (i.e. palliative care) based on their score.

At a minimum, each individual identified by the chosen HOMR tool should receive two additional assessments to screen for severe symptoms and the patient's desire to engage in advanced care planning (ACP):

  1. Edmonton Symptom Assessment System Revised (ESAS-R): scores of >6 will be flagged as 'severe'. Individual clinical teams can then choose to address the symptoms as appropriate for the patient, or consult a PC team.
  2. 4-item Advanced Care Planning Engagement Survey: Scores of 3-4 indicate a patient is ready to discuss ACP with a member of the clinical team. Clinical teams may choose to discuss ACP and goals of care (GoC) themselves, activate a local ACP/GoC intervention, or distribute ACP documentation (e.g. SpeakUp resources), as applicable.

Implementation of the mHOMR/HOMR-Now! intervention in each site will follow 4 phases informed by the Quality Implementation Framework:

  1. Site-Specific Considerations To facilitate successful implementation of the mHOMR/HOMR-Now! application, three strategies will be used to tailor implementation to the site-specific context, including needs, resources, fit, capacity, and readiness. Firstly, members of the coordinating and implementation research team will virtually conduct a detailed readiness assessment to determine the best way to implement the application given the local context of each site. Secondly, semi-structured focus group interviews will be held virtually at each site with the Implementation team (i.e. an executive champion, implementation lead, clinical lead, and information technology lead), as well as staff who will interact with the HOMR application output (i.e. either recipient of or actors on the notification). Lastly, select members of the implementation team will be virtually interviewed individually to determine site-specific implementation barriers and facilitators. Considering the unique site context, investigators will then work with stakeholders to determine the additional interventions that each site will implement once a patient has been identified as being at elevated risk for mortality and unmet palliative needs by the application. Notably, determination of secondary interventions will consider the normal workflow and resources available at each site. Details of these interventions will be provided in each site's individual protocol.
  2. Establishment of Information Technology Infrastructure for Implementation at each Site Logistics of the mHOMR or HOMR-Now! application will be discussed with the IT lead at each site to determine the technical approach for implementation in the electronic health record (EHR), including which application would be most appropriate to implement given each site's existing EHR. Some EHR platforms are used by more than one site; thus, solutions derived for one EHR will be shared among other partners as appropriate. Once the specific technical implementation process has been defined for each site, electronic and print educational material will be developed to teach staff at each site about mHOMR/HOMR-Now!, how the application works, and steps to take when they receive a notification.
  3. Development, Deployment, and Ongoing Support for mHOMR/HOMR-Now! Implementation Integration of the application into each site's EHR will be managed by the site IT lead and tested to ensure the application is correctly calculating the mortality risk scores and notifying the appropriate members of the care team. Once this is complete, each site will host a "go-live" kick-off event to help generate awareness, enthusiasm, and uptake of the intervention. In the following six to nine months (depending on the site's funding source), the application will be 'live' at each site, actively identifying newly admitted patients and notifying care teams to conduct the ESAS-R and 4-item ACP Engagement Survey as appropriate. Any additional site-specific interventions will also be implemented. Process and outcomes evaluations will also occur during phase 3. In addition to phase 1 interviews and focus groups, these evaluations will involve: (1) a second set of semi-structured interviews with members of the implementation team at each site to examine determinant factors associated with successful implementation of the mHOMR application; (2) a chart review to examine clinical and implementation outcomes, and; (3) analysis of linked health administrative data held at ICES to evaluate long-term clinical outcomes.
  4. Continuous Improvement of mHOMR/HOMR-Now! Implementation (Concurrent with Phases 1-3)

Each site will be regularly updated of study progress through teleconferences and newsletters. These communications will also share learnings across sites to improve implementation through establishment of best practices and identification of strategies to overcome implementation barriers. Additionally, this process will inform implementation of the application in other hospitals in the future.

All clinical secondary outcomes will be measured for HOMR positive patients for six to nine months pre and post implementation, and followed until end of study follow-up (up to one year after hospital discharge) or death. While each of these outcomes will be measured, aggregated, and linked to databases held at ICES, results from individual site data will be used to improve patient care by driving existing clinical best practices for palliative care, symptom management, and advanced care planning. In this sense, the clinical secondary outcome measures will also serve as indicators for continuous quality improvement at each hospital.

Being tested
modified Hospital One-year Mortality Risk (mHOMR)
Keywords
palliative care, end of life, clinical surveillance
Medical subject headings
Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modified Hospital One-year Mortality Risk (mHOMR)Other

    Also called Hospital One-year Mortality Risk-Now! (HOMR-Now!)

    Every inpatient will automatically be given the intervention (an mHOMR/HOMR Now! score) upon admission to hospital and considered for secondary interventions based on their score. Baseline threshold will be set as >0.21 (59% sensitivity and 90% specificity for 12-month mortality with mHOMR).

    At minimum each individual identified by the tool will receive two assessments to screen for severe symptoms and desire to engage in advance care planning (ACP):

    1. Edmonton Symptom Assessment System Revised: scores >6 will be flagged as severe. Clinical teams will address the symptoms as appropriate for the patient.
    2. 4-item Advanced Care Planning Engagement Survey: Scores of 3-4 indicate readiness to discuss ACP. Clinical teams may choose to discuss ACP and goals of care themselves, activate a local ACP intervention, or distribute ACP documentation.

    Both of these assessments will be done by a member of the treating team within 72 hours of the patient's hospital admission.

Study groups in NCT04171830
Study groupRoleWhat they receive
post HOMR interventionOtherpatients seen after HOMR implementation at that site
Receives: Other: modified Hospital One-year Mortality Risk (mHOMR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification and documentation of unmet palliative needs

    Proportion of admissions at each site identified by the application

    Measured: Through study completion, up to 9 months

  2. Identification and documentation of unmet palliative needs

    Proportion of admissions with a HOMR (modified or Now!) score >0.21 with ESAS symptom score >6 and/or documented desire to engage in ACP via the 4-item ACP Engagement Survey

    Measured: Through study completion, up to 9 months

Secondary outcomes (28)
  1. Acceptability - Qualitative perception of the implementation team that the application is agreeable, palatable, or satisfactory: The Hexagon Tool

    The Hexagon Tool, a measure of implementation readiness

    Measured: 1-3 months pre-intervention-implementation

  2. Adoption: the intention, initial decision, or action to employ the application

    The number of sites using the mHOMR/HOMR-Now! application at the end of the project

    Measured: Through study completion, up to 9 months

  3. Appropriateness - implementation team and staff perceived fit, relevance, or compatibility of the application for a given setting

    Semi-structured interview and focus group guides based on the Consolidated Framework for Implementation Research (CFIR)

    Measured: 1-3 months pre-intervention implementation and 1 month post study completion (at 10 months)

  4. Cost of delivering the mHOMR/HOMR-Now! application

    Monetary costs (using costing macros at ICES); estimates of staff time spent delivering the application

    Measured: Through study completion, up to 9 months

  5. Feasibility - extent to which the application can be successfully used within a given hospital's context

    Semi-structured interview guide based on the Consolidated Framework for Implementation Research (CFIR)

    Measured: 1 month post study completion (at 10 months)

  6. Fidelity to application implementation protocol

    Proportion of patient admissions identified by the application with a score >0.21 (i.e. having elevated risk of death and unmet palliative needs)

    Measured: Through study completion, up to 9 months

  7. Fidelity to application implementation protocol

    Proportion of patients identified by the application score >0.21 who have documented unmet palliative needs (ESAS-R and 4-item ACP Engagement Survey scores)

    Measured: Through study completion, up to 9 months

  8. Penetration

    Proportion of patient admissions screened by the application Denominator = total number of patient admissions

    Measured: Through study completion, up to 9 months

  9. Effectiveness

    Delivery (y/n) of inpatient palliative care services/interventions (e.g. palliative consult, pain management, etc.)

    Measured: Measured at inpatient hospital discharge for entire inpatient stay duration (average of 2 weeks)

  10. Effectiveness

    Mean length of time from hospital admission to receipt of any inpatient palliative care service

    Measured: Measured at inpatient hospital discharge for entire inpatient stay duration (average of 2 weeks)

  11. Effectiveness

    Delivery (y/n) of palliative home care

    Measured: Up to 52 weeks post hospital discharge or death, whichever is first

  12. Effectiveness

    Mean time to receipt of palliative home care

    Measured: Up to 52 weeks post hospital discharge or death, whichever is first

  13. Effectiveness

    Delivery (y/n) of a physician home visit

    Measured: Up to 52 weeks post hospital discharge or death, whichever is first

  14. Effectiveness

    Mean time to receipt of physician home visit

    Measured: Up to 52 weeks post hospital discharge or death, whichever is first

  15. Effectiveness

    Percent of patients with subsequent intensive care unit (ICU) admission

    Measured: Up to 52 weeks post hospital discharge or death, whichever is first

  16. Effectiveness

    Percent of patients with invasive procedures administered: venous catheterization, intubation, lung/liver biopsy, or cardiopulmonary resuscitation

    Measured: Measured at inpatient hospital discharge for entire inpatient stay duration (average of 2 weeks)

  17. Effectiveness

    Proportion of deaths in hospital

    Measured: At time of death, up to 52 weeks post-discharge

  18. Patient-centredness

    Location of death (community, acute care, other) as listed in the Vital Statistics-Deaths database held at ICES

    Measured: At time of death, up to 52 weeks post-discharge

  19. Safety - Conditions/Harms

    Proportion of patients with healthcare/medication associated conditions/harms as defined by the Canadian patient Safety Institute of the Canadian Institute for Health Information

    Measured: Measured at inpatient hospital discharge for entire inpatient stay duration (average of 2 weeks)

  20. Safety - Infections

    Proportion of patients with healthcare associated infections as defined by the Canadian patient Safety Institute of the Canadian Institute for Health Information

    Measured: Measured at inpatient hospital discharge for entire inpatient stay duration (average of 2 weeks)

  21. Safety - Patient Accidents

    Proportion of patients with inpatient accidents as defined by the Canadian patient Safety Institute of the Canadian Institute for Health Information

    Measured: Measured at inpatient hospital discharge for entire inpatient stay duration (average of 2 weeks)

  22. Efficiency

    Emergency department visit rate

    Measured: Up to 52 weeks post-discharge or death, whichever is first

  23. Efficiency

    Acute care re-admission rate

    Measured: Up to 52 weeks post-discharge or death, whichever is first

  24. Care Coordination

    Discharge destination, including proportion of patients discharged to community

    Measured: At hospital discharge

  25. Care Coordination

    Proportion of patients who receive home care within 1 week of hospital discharge (any vs. palliative-specific)

    Measured: Up to 1 week post-discharge

  26. Care Coordination

    Median time to home care within 1 week of hospital discharge (any vs. palliative-specific)

    Measured: Up to 1 week post discharge

  27. Care Coordination

    Patient length of hospital admission stay

    Measured: At hospital discharge

  28. Care Coordination

    Median time to follow-up visit with patient's Most Responsible Provider (generally a family physician) in community

    Measured: Up to 52 weeks post-discharge or death. whichever is first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start17 Jun 2019
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a non-randomized hybrid implementation-intervention comparative trial using pre- and post-implementation methods with an embedded qualitative component pre- and during intervention.
Masking
None (open label)
Enrolment
3,536 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04171830
Sponsor's protocol ID
1590
Acronym
HOMR
Status last verified
Jul 2026
First submitted
14 Nov 2019
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Walraven C. The Hospital-patient One-year Mortality Risk score accurately predicted long-term death risk in hospitalized patients. J Clin Epidemiol. 2014 Sep;67(9):1025-34. doi: 10.1016/j.jclinepi.2014.05.003. Epub 2014 Jun 25.

    PubMed 24973823
  • van Walraven C, McAlister FA, Bakal JA, Hawken S, Donze J. External validation of the Hospital-patient One-year Mortality Risk (HOMR) model for predicting death within 1 year after hospital admission. CMAJ. 2015 Jul 14;187(10):725-733. doi: 10.1503/cmaj.150209. Epub 2015 Jun 8.

    PubMed 26054605
  • van Walraven C, Forster AJ. The HOMR-Now! Model Accurately Predicts 1-Year Death Risk for Hospitalized Patients on Admission. Am J Med. 2017 Aug;130(8):991.e9-991.e16. doi: 10.1016/j.amjmed.2017.03.008. Epub 2017 Mar 31.

    PubMed 28366426
  • Wegier P, Koo E, Ansari S, et al. mHOMR: A pilot study of automated prospective clinical surveillance for inpatients having an elevated risk of one-year mortality. Under Review.

  • Watanabe 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 20832987
  • Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29.

    PubMed 28042072
  • Meyers DC, Durlak JA, Wandersman A. The quality implementation framework: a synthesis of critical steps in the implementation process. Am J Community Psychol. 2012 Dec;50(3-4):462-80. doi: 10.1007/s10464-012-9522-x.

    PubMed 22644083
  • Metz A, Louison L. The Hexagon Tool: Exploring Content. Chapel Hill, NC: National Implementation Research Network, Frank Porter Graham Child Development Institute, University of North Carolina at Chapel Hill; 2018:1-5.

Questions about this trial

What is this clinical trial studying?

A study testing modified Hospital One-year Mortality Risk (mHOMR) in people with Palliative Therapy and Implementation Science, run by Ottawa Hospital Research Institute at 13 sites in Canada.

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 2 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: enrolling by invitation, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification and documentation of unmet palliative needs (time frame: Through study completion, up to 9 months). The study lists 2 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 NCT04171830, which also lists 8 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 20 Jul 2026.

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