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Recruiting NCT06399614

Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition

Observational Hand Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Occupational Therapy-led Hand Therapy Service, Care as usual.
Who it may be relevant to
Registry conditions: Hand Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ireland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Evidenced Based Analytical Study of Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition

Overview

Traumatic hand injuries account for up to one third of acute hospital presentations. Current guidelines and standards of care recommend patients with hand trauma are seen by hand therapists, typically occupational therapists. 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. It is hoped the current proposed study will help shape future service development for those with hand injury including provision of evidence based occupational therapy assessment and intervention.

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:

1. 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. 2. 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. 3. 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.

Interventions

  • Other Occupational Therapy-led Hand Therapy Service
    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.
  • Other Care as usual
    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.

Primary outcome measures

  • 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.]
Secondary outcome measures (4)
  • 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.]
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Ireland · 5 centers
  • Beaumont Hospital — Dublin
  • Tallaght University Hospital — Dublin
  • Galway University Hospital — Galway
  • Ennis General Hospital - ULHG — Limerick
  • Nenagh General Hospital ULHG — Tipperary

Identifiers

NCT: NCT06399614 · ULimerick24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗