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Impact of an Allied Health Team in the Emergency Department on Older Adults' Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739515
Recruitment Status : Active, not recruiting
First Posted : November 13, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
University Hospital of Limerick
Information provided by (Responsible Party):
University of Limerick

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.


Condition or disease Intervention/treatment Phase
ED-based Allied Health Services Other: HSCP intervention Other: ED routine care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Health Services Research
Official Title: A Pilot Randomised Controlled Trial Exploring the Impact of a Dedicated Health and Social Care Professionals (HSCP) Team in the Emergency Department on the Quality, Safety and Cost-effectiveness of Care for Older Adults
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Arm Intervention/treatment
Experimental: HSCP team
Patients in this arm will receive comprehensive assessment and/or pre-discharge services by an ED-based HSCP team
Other: HSCP intervention
A team of HSCPs (physiotherapist, occupational therapist, medical social worker) will provide comprehensive functional assessment to older patients

Active Comparator: Routine care
Patients in this arm will receive routine ED care
Other: ED routine care
ED staff including consultants and nurses will provide patients with routine ED medical care.




Primary Outcome Measures :
  1. ED length of stay [ Time Frame: 1-24 hours (one day) after accessing the ED ]
    Hours from ED admission to discharge


Secondary Outcome Measures :
  1. Incidence of Representations [ Time Frame: 30 days, four months, and six months after index visit ]
    Percentages of patients who experience ED revisits, unplanned hospital visits or nursing home admissions after the ED index visit

  2. Incidence of Healthcare utilization [ Time Frame: 30 days, four months, and six months after index visit ]
    Percentages of patients who visit a general practitioner (GP), a public health nurse, outpatient departments, private consultations, home help, or allied health services after the ED index visit

  3. Functional status [ Time Frame: Baseline, 30 days and six months after index visit ]

    Patient global functioning as measured through the Barthel Index of Activities of Daily Living.

    The Barthel Index is a 10-item scale used to assess functional independence. The scoring varies across items:

    • bowels, bladder, toilet use, feeding, dressing, and stairs are scored from from 0 (dependence or inability) to 2 (independence)
    • grooming and bathing are scored either 0 (dependent or needs help) or 1 (independent)
    • transfer and mobility are scored 0 (dependent), 1 (major help), 2 (minor help), or 3 (independent).

    The total score ranges from 0 to 20 and it is obtained by adding up the scores of each item. Lower scores indicated increased disability. In case of rehabilitation, changes of more than two points in the total score reflect a probable genuine change, and change on one item from fully dependent to independent is also likely to be reliable.


  4. Patient quality of life [ Time Frame: Baseline, 30 days, four months and six months after index visit ]

    Quality of life assessed through the EuroQoL-5D-5L (EQ-5D-5L). The EQ-5D-5L is a standardised instrument developed by the EuroQoL Group (https://euroqol.org/euroqol/) to measure health-related quality of life.

    It includes a descriptive questionnaire assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 5 levels of self-rated severity (1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems). Each dimension is scored separately from 0 to 5 and the patient's "health state" is coded as a 5-digit string.

    It also includes a vertical visual analogue scale (VAS) to record the patient's self-rated health on a scale from 0 (worst health) to 100 (best health). The score assigned by the patient represents the self-reported level of health.


  5. Patient satisfaction with index visit [ Time Frame: At time of index visit ]

    Patient satisfaction with the index visit will be assessed using the Patient Satisfaction Questionnaire (PSQ-18) - Short Form.

    The PSQ-18 is an 18-item questionnaire that assesses patient's satisfaction with 6 aspects of care: technical quality, interpersonal manner, communication, financial aspects, time spent with the healthcare provider, and accessibility of care. General satisfaction is also assessed.

    The items are presented as statements about the experience of care and rated based on the patient's level of agreement with each statement from 1 (strongly agree) to 5 (strongly disagree).

    The PSQ-18 yields separate scores for each of seven different dimensions. All items should be scored so that high scores reflect satisfaction with medical care. After item scoring, items within the same sub-scale should be averaged together to create the 7 sub-scale scores.


  6. Process evaluation [ Time Frame: Within two months after completion of data collection (eight months after beginning of the study) ]
    The level of staff satisfaction and their perceptions on the implementation, delivery and impact of the intervention will be assessed with the HSCP team and other ED staff members (consultants, nurses) using qualitative methodologies (focus groups) after the completion of participant recruitment.

  7. Cost-effectiveness [ Time Frame: Four months after index visit ]
    An economic analysis will estimate the incremental cost effectiveness of the HSCP team from the perspective of the Irish public health service, as compared to usual care. We will estimate health care costs from reference costs from national data sources. Participants' responses to the EQ-5D-5L questionnaire will be used to estimate health states utilities using the Irish value set (20) and Quality-Adjusted Life Years (QALYs) for each treatment group will be estimated across all timepoints

  8. Nursing home admission [ Time Frame: 30 days and six months after index visit ]
    The rates of patients admitted to a nursing home will be captured at follow-up

  9. Mortality [ Time Frame: 30 days and six months after the index visit ]
    The rates of patients deceased will be captured at follow-up

  10. Hospital admission rate [ Time Frame: Within 72 hours of ED index visit ]
    Percentages of patients admitted to the ward from the ED



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739515


Locations
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Ireland
University Hospital Limerick
Limerick, Co. Limerick, Ireland, F858
Sponsors and Collaborators
University of Limerick
University Hospital of Limerick
Investigators
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Principal Investigator: Rose Galvin, PhD University of Limerick
Principal Investigator: Damien Ryan, PhD University Hospital of Limerick
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Limerick
ClinicalTrials.gov Identifier: NCT03739515    
Other Study ID Numbers: Optimend_WP4
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Limerick:
Emergency department
Health and Social Care Professional
Team care
Older patients
Effectiveness
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes