Clinical trial NCT06168721: ICF Core Set for Primary Care Physiotherapy
Official title: Development of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Keywords: ICF
Musculoskeletal Diseases
Physical Therapy Modalities
Primary Health Care
Community Health Services
Lead sponsor: University of Valladolid
Sponsor class: OTHER
Collaborators: name: Sanidad de Castilla y León
First posted: 2023-12-13
Enrollment: 46
Sex: ALL
Minimum age (years): 26
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The potential participants in this study should be physical therapists working in a primary care clinical setting. The resulting panel of experts would have sufficient expertise in this area. The study will focus on the Spanish region of 'Castilla and Leon', but efforts will be made to extend the scope to a national level.

Brief summary: Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. The development of these tools follows a scientific process that combines the perspectives of researchers, patients, professionals, and the care setting. Our research team has conducted preliminary studies and identified candidate ICF categories with good potential for inclusion in a preliminary version of an ICF Core Set for the treatment of musculoskeletal conditions in community physical therapy settings. The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of this ICF Core Set.

Detailed description: Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. Some ICF Core Sets are designed to describe the functioning of patients with musculoskeletal problems.

These Core Sets are focused on the acute phase, typical of emergency care, and the post-acute phase, intended for multidisciplinary teams in rehabilitation centers. However, no ICF core set exists for the final stages of these conditions, when the patient has been reintegrated into the community. The development of ICF Core Sets follows a scientific process that integrates the perspectives of researchers, patients, professionals, and the care setting. Therefore, preparatory studies have been carried out, taking as a reference the physiotherapy services in primary care, where most of these conditions are treated.

These preparatory studies have made it possible to draw up a list of ICF categories that are candidates for being part of an ICF core set specific to these services. To confirm the relevance of these categories, a cross-sectional observational study will be developed by recruiting a group of experts. The experts will carry out two rounds of the survey according to the Delphi method. To be part of this group, sufficient expertise in the field of primary care physiotherapy will be required. The categories that reach consensus among these experts will be proposed in the development of a tailored ICF Core Set for primary care physiotherapy services.

The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of an ICF Core Set for the management of musculoskeletal conditions in a primary care physiotherapy clinical setting. The availability of this tool would allow guiding physical therapy assessments, selecting optimal outcome measures, implementing person-centered care, and systematically recording clinical data.

Eligibility criteria: Inclusion Criteria:

* Be physiotherapists working in a primary care setting for the duration of the study.
* Have more than 5 years of experience in this clinical setting.
* Evidence of completion of at least 200 hours of additional training, teaching, research, and/or administrative activities related to the clinical setting.

Exclusion Criteria:

* Work in a rehabilitation center or hospital context.

Primary outcomes:
measure: Relevance of candidate ICF categories (First Delphi Round)
timeFrame: 2024-01/2024-06
measure: Judgment on the clinical utility of the selected ICF categories (Second Delphi Round)
timeFrame: 2024-01/2024-06
Secondary outcomes:
measure: Missing functioning concepts (First Delphi Round)
timeFrame: 2024-01/2024-06
Other outcomes:
measure: Sociodemographic data of the sample
timeFrame: 2024-01/2024-06
Locations:
city: Ólvega
country: Spain
facility: Ólvega Primary Health Center
state: Soria
Study officials:
affiliation: University of Valladolid
name: Sandra Jiménez del Barrio, PhD
role: STUDY_CHAIR
affiliation: University of Valladolid
name: Luis Ceballos Laita, PhD
role: STUDY_CHAIR
affiliation: University of Valladolid
name: María Teresa Mingo Gómez, PhD
role: STUDY_CHAIR
References:
citation: Hernandez-Lazaro H, Mingo-Gomez MT, Ceballos-Laita L, Medrano-de-la-Fuente R, Jimenez-Del Barrio S. Validation of the international classification of functioning, disability, and health (ICF) core sets for musculoskeletal conditions in a primary health care setting from physiotherapists' perspective using the Delphi method. Disabil Rehabil. 2023 Jul;45(15):2458-2468. doi: 10.1080/09638288.2022.2096128. Epub 2022 Jul 13.
citation: Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Lahuerta-Martin S, Hernando-Garijo I, Medrano-de-la-Fuente R, Ceballos-Laita L. Researcher's Perspective on Musculoskeletal Conditions in Primary Care Physiotherapy Units through the International Classification of Functioning, Disability, and Health (ICF): A Scoping Review. Biomedicines. 2023 Jan 20;11(2):290. doi: 10.3390/biomedicines11020290.
citation: Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Rodriguez-Fernandez AI, Areso-Boveda PB, Ceballos-Laita L. Validation of the International Classification of Functioning, Disability, and Health (ICF) core set for post-acute musculoskeletal conditions in a primary care physiotherapy setting from the perspective of patients using focus groups. Disabil Rehabil. 2024 Aug;46(16):3594-3601. doi: 10.1080/09638288.2023.2251392. Epub 2023 Sep 5.
citation: Hernandez-Lazaro H, Jimenez-Del Barrio S, Ceballos-Laita L, Lahuerta-Martin S, Medrano-de-la-Fuente R, Hernando-Garijo I, Mingo-Gomez MT. Multicentre cross-sectional study assessing content validity of the International Classification of Functioning, disability and health core set for post-acute musculoskeletal conditions in primary care physiotherapy services. J Rehabil Med. 2023 Nov 16;55:jrm11950. doi: 10.2340/jrm.v55.11950.
citation: Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Simarro-Martin A, Wisniowska-Szurlej A, Ceballos-Laita L. Development of an ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services in Spain: a Delphi study. Disabil Rehabil. 2025 Feb 11:1-10. doi: 10.1080/09638288.2025.2460723. Online ahead of print.