Development, Validation, and Evaluation of a Risk Assessment Tool for Contractures: the ORACLE Study

Contracture Clinical Trial

Official title: Development, Validation, and Evaluation of a Risk Assessment Tool for Contractures: the ORACLE Study

Status Recruiting

Clinical Trial Summary

The Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) is a risk assessment tool for contractures. The tool was originally designed and developed by a group of multidisciplinary health professionals within Dorset Healthcare University NHS Foundation Trust (DHUFT). Bournemouth University and DHUFT sponsored a match funded studentship to establish the academic validation of the tool.

The results from the previously conducted studies (Phase One) as part of this project: (i) a systematic review of the literature and an (ii) online Delphi survey with field experts provided initial evidence for further development, content validity, and modification of the tool.

The current study (Phase Two) aims to establish the psychometric validation, acceptability, and usability of the modified tool through formal testing on adult care home residents in Dorset. It consists of two streams of work: Stream A aims to establish the psychometric validation by completing the ORACLE assessments on adult care home residents. The assessments will be performed by the care home staff. In Stream B, a realist evaluation will be performed to explore the usability and practicality of ORACLE with selected care home managers and staff who were involved in organising and completing the assessments on ORACLE respectively.

The results from this two-phase design will then inform further revisions of the tool if required.

Clinical Trial Description

Joint contractures are described as any degree of reduction in the passive range of motion within a joint due to muscle or connective tissue shortening eventually leading to structural abnormalities within the affected joint. ). This can lead to further deterioration in limb and joint flexibility, mobility, and activities of daily living (ADL's).

It has been reported that the care home residents spend most of their time remaining sedentary. Reduced mobility or lack of physical activity adversely affects the residents' physical and psychological well-being of the residents, including reduced motivation to engage in physical and social activities, pain, increased risk of pressure sores, contractures, and physical dependency.

Structured risk assessments play an important role in referring patients to the appropriate health care practitioner and enacting early treatment strategies to reduce the risk of the condition progressing. However, there is a clear lack of a standardised, evidence-based measure that can actively identify the risk of contractures and trigger appropriate and timely referrals to healthcare professionals.

The tool, Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) was initially designed with the aim to address the gap mentioned above by a group of healthcare professionals (physiotherapists, occupational therapists, and nurses within Dorset Healthcare, Bournemouth Borough Council, Poole Borough Council, Dorset County Council, and Dorset CCG. The working party discussed the potential causes and factors associated with contracture development and/or progression based on their clinical experience and developed relevant themes to define the construct of the tool. The original construct developed underwent a series of transformations before a face-to-face consensus over a series of meetings to finally include eight items in the tool.

To establish the academic validation of the tool before widespread use and implementation, Dorset Health Care collaborated with Bournemouth University and sponsored a match-funded PhD Studentship. The PhD project has been structured into two main phases: Phase One: content validation and phase II: external validation.

Phase One:

In the first phase, first a systematic review of literature was conducted collate evidence on factors associated with contractures in literature. Based on the findings of this review, an online two-round Delphi consensus survey was designed and conducted with a group of purposively sampled 30 panel experts to determine which items were significant for inclusion in ORACLE. The collective data provided by the systematic review and Delphi survey was then used to further develop and modify ORACLE.

Phase Two:

The current study (Phase Two) aims to establish the psychometric validation, acceptability, and usability of the modified tool through formal testing on adult care home residents in Dorset. It consists of two streams of work: Stream A aims to establish the psychometric validation by completing the ORACLE assessments on adult care home residents. The assessments will be performed by the care home staff. In Stream B, a realist evaluation will be performed to explore the acceptability and usability of ORACLE with selected care home managers and staff who were involved in organising and completing the assessments on ORACLE respectively. The results from this two-phase design will then inform further revisions of the tool if required. ;

Related Conditions & MeSH terms

• Contracture
• Joint Contracture

• NCT number: NCT06042907
• Study type: Observational
• Source: Bournemouth University
• Contact: Hina Tariq
• Phone: 07404564696
• Email: htariq@bournemouth.ac.uk
• Status: Recruiting
• Start date: September 11, 2023
• Completion date: October 2024