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

NCT04171830 | Unknown

• 1 other identifier: 1590
• Study Type: interventional
• Target: 3,536
• Locations: 1 country
• Sites: 13

Brief 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 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.

Conditions

Palliative Therapy; Implementation Science; Screening; Terminal Care

Keywords

palliative care; end of life; clinical surveillance

Outcome Measures

Primary Outcomes (2)

• Identification and documentation of unmet palliative needs

  Proportion of admissions at each site identified by the application

  Through study completion, up to 9 months

• 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

  Through study completion, up to 9 months

Secondary Outcomes (28)

• Acceptability - Qualitative perception of the implementation team that the application is agreeable, palatable, or satisfactory: The Hexagon Tool

  1-3 months pre-intervention-implementation

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

  Through study completion, up to 9 months

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

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

• Cost of delivering the mHOMR/HOMR-Now! application

  Through study completion, up to 9 months

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

  1 month post study completion (at 10 months)

Interventions

modified Hospital One-year Mortality Risk (mHOMR) OTHER

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.

Also known as: Hospital One-year Mortality Risk-Now! (HOMR-Now!)

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Frailty Network: collaborator
• Centre for Aging and Brain Health Innovation: collaborator
• Canadian Foundation for Healthcare Improvement: collaborator
• Bruyère Health Research Institute.: collaborator
• William Osler Health System: collaborator
• Hopital Montfort: collaborator
• Queen's University: collaborator
• Pembroke Regional Hospital: collaborator
• Unity Health Toronto: collaborator
• Cambridge Memorial Hospital: collaborator
• The Ottawa Hospital: collaborator
• Queensway Carleton Hospital: collaborator
• University of Ottawa: collaborator
• The Hospital for Sick Children: collaborator
• ICES: collaborator
• London Health Sciences Centre: collaborator
• Windsor Regional Hospital: collaborator
• Humber River Hospital: collaborator
• North York General Hospital: collaborator
• Ontario Health - Quality: collaborator
• Healthcare Excellence Canada: collaborator
• Headwaters Health Care Centre: collaborator

Study Sites (13)

William Osler Health System

Brampton, Ontario, L6R37J, Canada

Location

Cambridge Memorial Hospital

Cambridge, Ontario, N1R3G2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Headwaters Health Care Centre

Orangeville, Ontario, L9W4X9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Montfort Hospital

Ottawa, Ontario, K1K0T2, Canada

Location

Queensway Carleton Hospital

Ottawa, Ontario, K2H8P4, Canada

Location

Pembroke Regional Hospital

Pembroke, Ontario, K8A1G8, Canada

Location

North York General Hospital

Toronto, Ontario, M2K1E1, Canada

Location

Humber River Hospital

Toronto, Ontario, M3M0B2, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Windsor Regional Hospital

Windsor, Ontario, N8W1L9, Canada

Location

Related Publications (8)

• 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.

  PMID: 24973823 BACKGROUND

• 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.

  PMID: 26054605 BACKGROUND

• 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.

  PMID: 28366426 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20832987 BACKGROUND

• 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.

  PMID: 28042072 BACKGROUND

• 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.

  PMID: 22644083 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Death

Interventions

Hospitals

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: June 17, 2019
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)