NCT03739515

Brief Summary

The study aims to examine the impact of implementing a dedicated team of Health and Social Care Professionals (HSCPs) in the emergency department (ED) of a large Irish hospital on the quality, safety and cost-effectiveness of care for older adults (aged ≥65). Early assessment and intervention provided by the HSCP team will be compared to routine ED care to explore potential benefits related to key ED outcomes, including length of stay as well as hospital admissions and patient satisfaction/quality of life. This study is part of an ongoing interdisciplinary project funded by the Health Research Board of Ireland through the Research Collaborative on Quality and Patient Safety (RCQPS) Grant Call 2017. The project is led by Dr Rose Galvin, Senior Lecturer in Physiotherapy at the University of Limerick (UL, Ireland), and overseen by an interdisciplinary steering group of expert researchers and clinicians in Emergency Medicine and Allied Health.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

November 7, 2018

Last Update Submit

September 3, 2019

Conditions

Keywords

Emergency departmentHealth and Social Care ProfessionalTeam careOlder patientsEffectiveness

Outcome Measures

Primary Outcomes (1)

  • ED length of stay

    Hours from ED admission to discharge

    1-24 hours (one day) after accessing the ED

Secondary Outcomes (10)

  • Incidence of Representations

    30 days, four months, and six months after index visit

  • Incidence of Healthcare utilization

    30 days, four months, and six months after index visit

  • Functional status

    Baseline, 30 days and six months after index visit

  • Patient quality of life

    Baseline, 30 days, four months and six months after index visit

  • Patient satisfaction with index visit

    At time of index visit

  • +5 more secondary outcomes

Study Arms (2)

HSCP team

EXPERIMENTAL

Patients in this arm will receive comprehensive assessment and/or pre-discharge services by an ED-based HSCP team

Other: HSCP intervention

Routine care

ACTIVE COMPARATOR

Patients in this arm will receive routine ED care

Other: ED routine care

Interventions

A team of HSCPs (physiotherapist, occupational therapist, medical social worker) will provide comprehensive functional assessment to older patients

HSCP team

ED staff including consultants and nurses will provide patients with routine ED medical care.

Routine care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥65 years
  • Medically stable (treating physician)
  • Off baseline mobility
  • Capacity (Mini Mental State Examination score ≥17) and willingness to provide informed consent
  • Presenting during HSCP operational hours (8am-5pm Monday-Friday)

You may not qualify if:

  • Under 65 years
  • Medically unstable
  • Neither the patient nor the carer can communicate in English sufficiently to complete consent or baseline assessment
  • Present outside HSCP operational hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Limerick

Limerick, Co. Limerick, F858, Ireland

Location

Related Publications (9)

  • Carter EJ, Pouch SM, Larson EL. The relationship between emergency department crowding and patient outcomes: a systematic review. J Nurs Scholarsh. 2014 Mar;46(2):106-15. doi: 10.1111/jnu.12055. Epub 2013 Dec 19.

    PMID: 24354886BACKGROUND
  • Arendts G, Fitzhardinge S, Pronk K, Hutton M. Outcomes in older patients requiring comprehensive allied health care prior to discharge from the emergency department. Emerg Med Australas. 2013 Apr;25(2):127-31. doi: 10.1111/1742-6723.12049. Epub 2013 Feb 19.

    PMID: 23560962BACKGROUND
  • Cassarino M, Robinson K, Quinn R, Naddy B, O'Regan A, Ryan D, Boland F, Ward ME, McNamara R, McCarthy G, Galvin R. Effectiveness of early assessment and intervention by interdisciplinary teams including health and social care professionals in the emergency department: protocol for a systematic review. BMJ Open. 2018 Jul 16;8(7):e023464. doi: 10.1136/bmjopen-2018-023464.

    PMID: 30012796BACKGROUND
  • Trepel D, Ruiz-Adame M, Cassarino M, Ahern E, Devlin C, Robinson K, O'Shaughnessy I, McCarthy G, Corcoran C, Galvin R. The cost effectiveness of early assessment and intervention by a dedicated health and social care professional team for older adults in the emergency department compared to treatment-as-usual: Economic evaluation of the OPTI-MEND trial. PLoS One. 2024 Jun 25;19(6):e0298162. doi: 10.1371/journal.pone.0298162. eCollection 2024.

  • Cassarino M, Cronin U, Robinson K, Quinn R, Boland F, Ward ME, McNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. Development and delivery of an allied health team intervention for older adults in the emergency department: A process evaluation. PLoS One. 2022 May 26;17(5):e0269117. doi: 10.1371/journal.pone.0269117. eCollection 2022.

  • Cassarino M, Robinson K, Trepel D, O'Shaughnessy I, Smalle E, White S, Devlin C, Quinn R, Boland F, Ward ME, McNamara R, Steed F, O'Connor M, O'Regan A, McCarthy G, Ryan D, Galvin R. Impact of assessment and intervention by a health and social care professional team in the emergency department on the quality, safety, and clinical effectiveness of care for older adults: A randomised controlled trial. PLoS Med. 2021 Jul 28;18(7):e1003711. doi: 10.1371/journal.pmed.1003711. eCollection 2021 Jul.

  • Griffin A, O'Neill A, O'Connor M, Ryan D, Tierney A, Galvin R. The prevalence of malnutrition and impact on patient outcomes among older adults presenting at an Irish emergency department: a secondary analysis of the OPTI-MEND trial. BMC Geriatr. 2020 Nov 7;20(1):455. doi: 10.1186/s12877-020-01852-w.

  • Cassarino M, Robinson K, O'Shaughnessy I, Smalle E, White S, Devlin C, Quinn R, Trepel D, Boland F, Ward ME, McNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol. Trials. 2019 Oct 15;20(1):591. doi: 10.1186/s13063-019-3697-5.

  • Cassarino M, Cronin U, Robinson K, Quinn R, Boland F, Ward ME, MacNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. Implementing an allied health team intervention to improve the care of older adults in the emergency department: protocol for a process evaluation. BMJ Open. 2019 Jul 16;9(7):e032645. doi: 10.1136/bmjopen-2019-032645.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rose Galvin, PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR
  • Damien Ryan, PhD

    University Hospital of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
To minimise the possibility of selection bias, a person independent of the recruitment process will complete random group allocation. Computer generated random numbers will be created and placed in sealed envelopes by this independent person. These numbers will be stored in the pre-sealed envelopes in a locked drawer in the Health Research Institute at the Clinical Education and Research Centre (CERC). Allocation will be revealed after recruitment by a telephone call from the dedicated research nurse to this independent person, who will open the next envelope in the sequence and give the randomisation information to the research nurse. Each envelope will be opened on enrolment of an eligible participant. After allocation is revealed, the appropriate intervention will be organised by the team. In addition, the outcome assessment will be conducted by a research nurse blinded to the patient allocation in order to reduce potential detection bias.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Eligible participants will be randomly assigned to either the experimental group (ED-based HSCP intervention) or the control group (ED routine care). By assigning participants at random, it is possible to infer that any observed group differences are attributable to the independent variable (the intervention under investigation).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 13, 2018

Study Start

December 3, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared with other researchers

Locations