- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06399614
Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition
An Evidenced Based Analytical Study of Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Traumatic hand injuries account for up to one third of acute hospital presentations. The establishment of Occupational Therapy-led hand therapy clinics is gaining momentum within the literature as improving hand trauma patient care and outcomes. It is identified within the literature that point of acute contact service areas such as accident and emergency or injury unit type settings could benefit from a hand therapy service. The benefits reported include: better patient outcomes, reduced waiting times, reduction of patient presentations to consultant led clinics, faster turnaround of patient care and discharge, reduction of patient complaints, improved patient satisfaction, and reduced costs to the health service.
The proposed study aims to explore the effectiveness of occupational therapy-led hand therapy services for the adult population presenting acutely to an injury unit or emergency department setting with a hand condition. The research project will consist of an analytical study, involving four different sites in Ireland to enrich findings, and to aid future service development. One site will be the comparison site, as it does not have access to occupational therapy, and will offer patients 'care as usual' upon attendance. Outcome measures will be used for all participants and will be completed at initial patient contact, at week eight and at six months. Study objectives include:
- To define the demographics and characteristics (including functional ability, pain level, and quality of life) of adult service users pre- and post-acute attendance with a hand condition.
- To profile clinical and process outcomes after initial visit, at 8-week and 6-month follow-up for patients provided with care as usual and those with targeted hand therapy led assessments and interventions.
- To explore any objective and subjective patient, organizational, and societal benefits of hands service provision.
It is hoped the current proposed study will improve the quality, safety, timeliness and cost of care provided to adults who present to acute services with a hand condition. This information may help shape future service development for those with hand injury including provision of evidence based occupational therapy-led services.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Margo Sheerin
- Phone Number: 086 6011586
- Email: margo.sheerin@hse.ie
Study Contact Backup
- Name: Ann-Marie Morrissey, PhD
- Phone Number: 086 6011586
- Email: AnnMarie.Morrissey@ul.ie
Study Locations
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Dublin, Ireland
- Recruiting
- Beaumont Hospital
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Contact:
- Eileen Walsh
- Phone Number: 01-797 7520
- Email: eileenwalsh@beaumont.ie
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Dublin, Ireland
- Not yet recruiting
- Tallaght University Hospital
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Contact:
- Simone Derham
- Phone Number: 01 4142790
- Email: simone.derham@tuh.ie
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Contact:
- Margo Sheerin
- Phone Number: 0877680504
- Email: margo.sheerin@hse.ie
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Galway, Ireland
- Not yet recruiting
- Galway University Hospital
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Contact:
- Lorna Spellman
- Phone Number: 091 542431
- Email: Lorna.Spellman@hse.ie
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Limerick, Ireland
- Recruiting
- Ennis General Hospital - ULHG
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Contact:
- Brenda Bleach, MHSc
- Phone Number: 065 6863121
- Email: Brenda.bleach@hse.ie
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Contact:
- Margo Sheerin, BSc
- Phone Number: 0866011586
- Email: margo.sheerin@hse.ie
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Tipperary, Ireland
- Recruiting
- Nenagh General Hospital ULHG
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Contact:
- Margo Sheerin, BSc
- Phone Number: 0866011586
- Email: margo.sheerin@hse.ie
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Contact:
- Damien Ryan, MD
- Phone Number: 06731491
- Email: Damien.ryan@hse.ie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years of age and older
- Adults presenting with an injury and/ or condition of their hand and/or forearm inhibiting function inclusive of: fractures (proximal, middle, and distal phalanx); tendon and soft tissue injury (PIPJ volar plate, central slip +/- lateral band, mallet injury, trigger finger, flexor injury, extensor injury, thumb tendon and ligament injury); digital nerve injury; or carpal tunnel injury.
Exclusion Criteria:
- Patients under 18 years of age
- Patients presenting with complex medical issues in conjunction with a hand injury who may require an alternative pathway, for example, transfer to a different hospital, requiring prioritisation of another medical emergency
- Other exclusions at the discretion of the service depending on team capacity and expertise
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention Group
Participants who attend an emergency department or injury unit with access to occupational therapy will be referred to an occupational therapy-led hand therapy clinic.
Assessment and intervention for their hand injury will be provided by the occupational therapist, based on existing hand therapy protocols and guidelines.
The consultant in charge and the occupational therapist will make clinical judgements with regard suitability for occupational therapy clinics for conservative management of their condition based on patient need at point of triage.
Types of interventions provided by the occupational therapist will include customised splinting, targeted exercises and activities, swelling reduction, scar management, desensitisation, education on type of injury, and occupation based intervention.
All interventions provided are within occupational therapists' scope of practice and are evidence based.
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Types of interventions provided by the therapist will include splinting, targeted exercises and activities, occupation-based intervention, edema management, scar management; desensitisation, functional tasks completion, and education.
All interventions provided are within occupational therapists' scope of practice and are evidence based.
Number of treatment sessions will be individualised to the patient and guided by stages of recovery.
|
|
Care as Usual Group
Participants attending an emergency department of injury unit, do not have access to occupational therapy services and will undergo 'care as usual' in line with the services' protocols and procedures.
Care as usual involves standard nursing and medical care and may include: wound care, use of 'off the shelf' orthosis, education, and onward referral to other healthcare professionals.
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Care as usual group: Participants attending an emergency department of injury unit, do not have access to occupational therapy services and will undergo 'care as usual' in line with the services' protocols and procedures.
Care as usual involves standard nursing and medical care and may include: wound care, use of 'off the shelf' orthosis, education, and onward referral to other healthcare professionals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function: our primary outcome is change in patient function for those with acutely presenting hand conditions.
Time Frame: The QuickDASH will be administered at baseline, at 8-weeks (post intervention), and at six months.
|
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) outcome measure is a self report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
The QuickDASH contains an 11 item disability/symptom scale, with two optional scales capturing sport/art and work ability.
The QuickDASH is valid, reliable and has demonstrated high responsive in outpatients with hand trauma and degenerative hand conditions and can be used for clinical and research purposes.
A lower score on the QuickDASH denotes lower disability, whilst a high score denotes higher rates of disability.
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The QuickDASH will be administered at baseline, at 8-weeks (post intervention), and at six months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational Value and Competence of those with acutely presenting hand conditions.
Time Frame: The Occupational Self Assessment - Short Form (OSA-SF) will be administered at baseline, at 8-weeks (post intervention), and at six months.
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The Occupational Self Assessment - Short Form (OSA-SF) is a validated measure designed to assess one's perceived occupational competence and value, as well as supporting the client by informing goal setting and treatment planning.
A higher score denotes higher competence and higher value with performance of occupations, with a maximum score of 48 in the 'competence' subset and 36 in the 'value' subset
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The Occupational Self Assessment - Short Form (OSA-SF) will be administered at baseline, at 8-weeks (post intervention), and at six months.
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Pain reported by those with acutely presenting hand conditions.
Time Frame: The pain verbal rating scale will be administered at baseline, at 8-weeks (post intervention), and at six months.
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A pain verbal rating scale (VRS) will be used to measure pain experience, as rated by the patient with '0' indicating no pain, and '10' indicating worst imaginable pain
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The pain verbal rating scale will be administered at baseline, at 8-weeks (post intervention), and at six months.
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Change in health related quality of life for those with acutely presenting hand conditions using a visual scale.
Time Frame: The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.
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The EuroQoL EQ-5D-5L will be used to examine health related quality of life outcomes for patients.
This is a standardised measure of health status developed by the EuroQoL group to provide a descriptive profile and an index value for health status.
A visual analogue scale reporting respondents self-rated health on a vertical visual analogue scale from 'best imaginable health state' (100) to 'worst imaginable health state' (0) is used to capture self reported change in health related quality of life over time.
The visual scale represents the patients perspective and is conceptually different from the index system where a value is attached to a ED-5D-5L profile according to a set of weights that reflect average perspectives on health state.
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The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.
|
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Change in health related quality of life for those with acutely presenting hand conditions using a descriptive system.
Time Frame: The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.
|
The EuroQoL EQ-5D-5L will be used to examine health related quality of life outcomes for patients.
This is a standardised measure of health status developed by the EuroQoL group to provide a descriptive profile and an index value for health status.
A descriptive system with five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression is completed.
This part of the outcome tool can be used to generate a health state profile.
Each health state can be assigned an index score and analysed against Irish norms.
This helps better understand patients health state in relation to each of the five domains as well as being useful for health economic analysis.
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The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Damien Ryan, University of Limerick
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULimerick24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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