The NRC Dataset. Developing a Minimum Dataset for Multidisciplinary Rehabilitation: a Modified E-Delphi Study

NCT06726135 | Not Yet Recruiting DMC

• 1 other identifier: 345539
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Several rehabilitation datasets are presently in use for specific patient groups in England. The 'National Clinical Audit of Specialist Rehabilitation for patients with complex needs following major injury' (NCASRI) evaluated outcomes within a cohort of Major Trauma patients between 2015 and 2018 using data from two of these datasets. The NCASRI project outlined some of the shortcomings of the pre-existing datasets and highlighted the need for a single National Rehabilitation Dataset to provide long term evaluation of a variety of patient presentations. The proposed study will seek to develop such a dataset by means of an E-delphi study. This study will seek consensus from a panel of experts on the data items required to measure the effectiveness and socio-economic impact of multidisciplinary inpatient rehabilitation. Providing commissioners, researchers and clinicians with the data required to improve patient care, conduct research and develop rehabilitation services. There are three potential phases to this study:

• Phase one involves the establishment of a core domain set, outlining what information (data) should be included in the NRC core dataset.
• Phase one will consist of at least 2 rounds of voting, with successive rounds of voting undertaken until an a-priori consensus of 70% is reached for all core data items marked as mandatory/critical data in fitting OMERACT guidelines.
• After 2 rounds, any data item that have reached consensus will be included in the final dataset. These core domain (data items) will then be excluded from subsequent rounds of voting.
• A maximum of 4 rounds will be allowed in Phase 1. At which point the highest-ranking data items remaining with a consensus above 60% from each of the pre-identified categories will be included in the final dataset.
• Phase two will explore what tools should be used to collect the core domains (outcome measure instruments) for each category outlined in phase 1.
• Phase 2 will follow the same protocol for including outcome measure instruments into the core outcome set as were required to include core data items from phase 1.
• If a consensus of equal or greater than 60% cannot be reached using an E-Delphi method in either phase 1 or phase 2 then a virtual meeting will be held amongst all expert panel members to reach consensus using a nominal group technique (phase 3).

Conditions

Pain; Traumatic Brain Injury; Major Trauma; Multiple Sclerosis; Amputees / Rehabilitation; Spinal Cord Injuries (SCI); Functional Neurological Disorder; Intensive Care Unit (ICU) Acquired Weakness (ICU - AW); Trauma Related Injuries

Keywords

E-delphi; Delphi; Multidisciplinary; Rehabilitation; Core outcome set; Dataset; national rehabilitation centre; outcome measure instruments; inpatient

Outcome Measures

Primary Outcomes (1)

• To develop a Core Outcome Set (COS) for rehabilitation to be used as the foundation of the National Rehabilitation Centre Dataset.

  The core outcome set (Primary outcome) will include core data Items centered on 6 key themes: 1. Demographic variables 2. Health indicators and associated outcome measures 3. Socio-economic variables (healthcare costs, salary etc.) 4. Service delivery/care pathway variables (admission, transfer and discharge dates/locations etc.) 5. Information associated with previous social function, employment and education and return to these activities following their injury/illness. 6. Injury/condition-specific data Each data item will include details regarding how this item will be measured

  From enrolment to conclusion of the stufy (6 months)

Other Outcomes (1)

• To develop a Core Outcome Set (COS) for rehabilitation to be used as the foundation of the National Rehabilitation Centre Dataset.

  From enrolment to conclusion of the study (6 months)

Study Arms (1)

Experts in the field of rehabilitation with knowledge in outcome monitoring and service evaluation

This study has one study cohort, consisting of a diverse panel of expert clinicians, researchers and managers from a variety of professional backgrounds. These study participants will be purposefully selected based on their knowledge of which demographic, socio-economic and healthcare related variables, as well as any associated outcome measure instruments should be collected as part of a rehabilitation dataset to evaluate the clinical efficacy and cost effectiveness of inpatient multidisciplinary rehabilitation.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The expert panel (study participants) will include clinicians, researchers and managers from a variety of fields. These experts will be purposefully selected based on their knowledge of how best to evaluate the clinical effectiveness and cost efficiency of inpatient rehabilitation services. This knowledge will include an understanding of which outcome measure instruments are most appropriate to monitor patients' health, social and economic outcomes and what demographic and socio-economic variables are important to record. The expert panel will have experience treating the cohort of patients that the National Rehabilitation Centre (NRC) will support or have experience developing trauma / rehabilitation registries.

You may qualify if:

• The panel will aim to include clinicians with a minimum of 5 years' experience from a variety of professional backgrounds within the following specialist areas:
• Neuro Rehab
• Trauma Rehab
• Community Rehab
• Outpatient Rehabilitation services
• Defence medical services
• Psychology services
• Amputee Rehab
• Speech and Language therapy
• Emergency department
• Critical Care
• Trauma and Orthopaedics
• Rehabilitation Medicine
• It is expected that the expert panel will include:
• Medical Doctors

You may not qualify if:

• Individuals will be excluded from the expert panel for any of the following reasons:
• They do not have 5 years' experience in their specialist field
• They do not have an understanding of various health indicators and the appropriate outcome measure instruments required to evaluate these health indicators.
• They have no understanding of how demographic and socio-economic variables impact health outcomes
• They have no understanding of how to evaluate clinical effectiveness and cost efficiency of inpatient rehabilitation services.
• Their professional background is not represented in the above noted specialist areas

Sponsors & Collaborators

• ThomasCorbett: lead
• Nottingham University Hospital NHS Trust: collaborator

Related Publications (18)

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• NCASRI Project team, Lead: Turner-Stokes L., 'Specialist Rehabilitation following major Injury (NCASRI) Final Audit report'.

  BACKGROUND

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MeSH Terms

Conditions

Pain; Brain Injuries, Traumatic; Multiple Sclerosis; Spinal Cord Injuries; Conversion Disorder

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Somatoform Disorders; Mental Disorders

Study Officials

• Thomas Corbett, MSc

  Research at the National Rehabilitation Centre (part of Nottingham University Hospital NHS Trust)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Hyman-Taylor

CONTACT

0115 924 9924; pauline.hymantaylor@nhs.net

Alison Loyd

CONTACT

0115 924 9924; nuhnt.researchsponsor@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share