Development of a Core Outcome Set for research studies with older adults in the Emergency Department-CREAT-ED

The number of people over the age of 65 is increasing as in their attendance rates to Emergency Departments. This cohort are at high risk of health and functional decline post ED attendance and often experience other negative outcomes such as prolonged waiting times and limited staff communication therefore more research is needed to improve care and treatment of older adults in the Emergency Department.

Studies that aim to improve care and treatment measure how effective a treatment is at improving various ‘outcomes’ and can focus on patient experience, health conditions or hospital services however the use of different outcome measures can make it difficult to determine effectives of studies.


In the context of a proliferation of intervention studies with older adults in the ED the lack of a core outcome set hampers the ability to review evidence in this area. The development of a COS would aim to address outcome heterogeneity in intervention studies based in the ED and with genuine stakeholder involvement throughout the process to ensure the COS reflects what matters most to older adults.

A review of existing COSs involving older adults are primarily focused on specific conditions such as delirium (Rose et al, 2021) or specific interventions including malnutrition (Visser et al, 2022). While some patient-reported and clinical outcomes from these COSs may overlap with the COS we plan to develop none of these existing COS's include important process outcomes specific to the Emergency Department (ED) setting (e.g. ED waiting time, ED re-attendance) for older adults with undifferentiated medical complaints.

In this study we want to work with older adults, their families and / or caregivers, healthcare staff, researchers, and other stakeholders to reach agreement on what outcomes should be measured in all studies involving older adults in the Emergency Department.

Aims: The primary aim of this study is to develop an evidence and consensus-based Core Outcome Set (COS) for research studies with older adults in the Emergency Department (ED).

Objectives: In order to meet the overall aim the project will include eight objectives with a defined timeline for completion of each, set out in a Gantt chart.
1. Establish project management and governance structures
2. Prospective registration of the overall COS development study protocol
3. Identify commonly reported outcome domains and associated instruments in trials involving older adults in the ED.
4. Synthesize qualitative research evidence on older adults ED experiences, or their care priorities or their experiences related to / following an ED visit
5. Identify outcomes following care or treatment in the ED valued by key stakeholders
6. Develop a Core Outcome Set for use in research studies based/ initiated in the Emergency Department with older adults
7. Identify outcome measure instruments for each Core Outcome identified in the COS
8. Disseminate the COS

Contributors

Kara Mc Loughlin - Principal Investigator- University of Limerick
Dr Katie Robinson - Principal Investigator/Supervisor-University of Limerick
Prof Rose Galvin - Supervisor-University of Limerick
Dr Elaine Toomey-Supervisor-University of Galway
Dr Jay Banerjee-Researcher Co-applicant-Uni of Leicester (Dept of Public Health Sciences)/University Hospitals of Leicester NHS Trust (Emergency Department)
Dr Jon Salsberg-Researcher Co-applicant -University of Limerick
Dr Rosa McNamara-Researcher Co-applicant-St Vincent's University Hospital/University College Dublin
Dr Marica Cassarino-Researcher Co-applicant-University College Cork
Prof Pauline Meskell-Collaborator -University of Limerick
Prof Cathal O Donnell-Collaborator-University of Limerick
Prof Margaret O Connor-Collaborator-University of Limerick/,University Hospital Limerick,
Dr Damien Ryan-Collaborator-School of Medicine, Faculty of Education and Health Sciences, University of Limerick, Ireland Limerick EM Education Research Training (ALERT), Emergency Department, University Hospital Limerick, Dooradoyle, Limerick, Ireland
Dr Shan Liu-Collaborator -Massachusetts General Hospital, Department of Emergency Medicine, Harvard Medical School
Dr Katie Dainty-Collaborator-University of Toronto
Dr PJ Harnett-Collaborator- National Integrated Care Programme for Older Persons Health Service Executive, Ireland
Dr Don Melady-Collaborator-University of Toronto/,Schwartz-Reisman Emergency Centre, Mount Sinai Hospital, Toronto

Further Study Information

Current Stage: Ongoing
Date: May 2023 - May 2027
Funding source(s): This research is funded through the Health Research Board of Ireland (HRB)Investigator Led project (ILP-HSR-2022-010). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.


Health Area

Disease Category: Health care of older people

Disease Name: Emergency Department-undifferentiated conditions

Target Population

Age Range: 65

Sex: Either

Nature of Intervention: Intensive care

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- Service commissioners
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Literature review
- Systematic review

This will include a scoping review of current randomized controlled trials, a rapid qualitative evidence synthesis Participatory research methods including focus groups and an e-Delphi study in order to develop the COS. A protocol for the COS development will be published in line with the Core Outcome set-Standardised Protocol Items (COP-STAP) and as per the minimum standard we will ensure stakeholder involvement. The research or practice setting(s) in which the COS is to be applied is research on interventions delivered in, or initiated, in the Emergency Department in high income countries. The health condition(s) covered by the COS are inclusive of all health conditions that older adults present to the Emergency Department with. The population(s) covered by the COS are older adults aged 65 years+. The intervention(s) covered by the COS includes all interventions bar drug therapy or surgical interventions as these relate to specific conditions.

Linked Studies

    No related studies


Related Links