Clinical trial NCT06399614: Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition
Official title: An Evidenced Based Analytical Study of Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hand Injuries
Keywords: Hand injury
Hand conditions
Occupational Therapy
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged 18 years of age and older attending acutely with a hand injury or condition.

Brief summary: 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.

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

Primary outcomes:
measure: Function: our primary outcome is change in patient function for those with acutely presenting hand conditions.
timeFrame: The QuickDASH will be administered at baseline, at 8-weeks (post intervention), and at six months.
Secondary outcomes:
measure: Change in health related quality of life for those with acutely presenting hand conditions using a visual scale.
timeFrame: The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.
measure: Change in health related quality of life for those with acutely presenting hand conditions using a descriptive system.
timeFrame: The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.
measure: Occupational Value and Competence of those with acutely presenting hand conditions.
timeFrame: The Occupational Self Assessment - Short Form (OSA-SF) will be administered at baseline, at 8-weeks (post intervention), and at six months.
measure: Pain reported by those with acutely presenting hand conditions.
timeFrame: The pain verbal rating scale will be administered at baseline, at 8-weeks (post intervention), and at six months.
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Limerick
country: Ireland
facility: Ennis General Hospital - ULHG
city: Tipperary
country: Ireland
facility: Nenagh General Hospital ULHG
Study officials:
affiliation: University of Limerick
name: Damien Ryan
role: PRINCIPAL_INVESTIGATOR
References: