Clinical trial NCT04135976: Applicability of the ICF in Primary Care Physiotherapy Units in the Health Service of Castille and Leon (Spain)
Official title: Applicability of the International Classification of Functioning, Disability and Health (ICF) in Primary Care Physiotherapy Units in the Health Service of Castille and Leon (Spain)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases or Conditions
Keywords: physiotherapy
primary health care
ICF
core set validation
musculoskeletal conditions
Lead sponsor: University of Valladolid
Sponsor class: OTHER
Collaborators: name: Sanidad de Castilla y León
First posted: 2019-10-23
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population over 18 years of age that has been treated in a physiotherapy unit in primary care during the last year, or is going to be treated in these units during the development of this research project.

Brief summary: The primary care physiotherapy units of the Spanish health service in Castille and Leon (SACYL) are responsible for providing physiotherapy treatments to the general population. Being part of the primary health care system, the actions of these units are aimed at the treatment of common conditions that do not involve severity, frequently musculoskeletal disorders.

The work of physiotherapists is closely related to the functionality of patients and, in this sense, the World Health Organization (WHO) has proposed the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework to characterize the functional status of individuals.

The use of ICF in the clinical setting is not sufficiently widespread due to the the difficulties that the use of such an exhaustive classification implies in practice. In an attempt to address this problem, the WHO has encouraged the development of reduced versions aimed at responding to specific conditions or care contexts.

The idea behind the development of core sets is that it is possible to select a number of categories so as to capture the essence of a given clinical process, allowing an agile use of the ICF. However, in order to put these core sets into practice, it is necessary to check that the selected categories are valid from the perspective of the participants in the clinical processes.

The purpose of this research project is to determine whether the musculoskeletal core sets of the ICF are applicable in SACYL primary care physiotherapy units. This implies knowing if the categories already selected in these sets are representative of the health aspects considered as most relevant in the clinical context of physiotherapy in primary care.

To achieve this, four studies will be conducted to capture the perspective of patients, physiotherapists, researchers and clinical practice. This information will be translated into the language of the ICF to obtain comparable categories with those present in the core sets.

In this way, this research project will make possible to validate or adapt the core sets of the ICF for musculoskeletal conditions, in a specific clinical context of physiotherapy in primary care.

Detailed description: Preliminary studies will attempt to capture the perspectives of all agents involved in the SACYL primary care physiotherapy clinical processes.

The perspective of the patients will be collected by means of a qualitative study through focal groups of people who have been attended in physiotherapy units in primary care. Each focus group will be made up of five patients who will be provided with information about the ICF and will be encouraged to express themselves on the aspects that they consider most relevant when they are attended in primary care physiotherapy units. The duration of these focus groups will be 30 minutes and as many groups as necessary will be conducted to reach 100% saturation. The information obtained will be translated into second level categories of the ICF, so that it can be compared with those present in the already existing core sets.

The perspective of the physiotherapists will be gathered through a Delphi study. Physiotherapists with experience in the care context under study will be selected and the information will be collected through online surveys. Three rounds will be carried out, translating the information obtained into second level categories of the ICF, and providing feedback in each round to the participants.

The research perspective will be studied through a systematic review of the scientific literature. To this end, the main databases will be scrutinized and studies that investigate musculoskeletal conditions will be selected in a context compatible with that of physiotherapy in primary care. The data will be obtained through the outcome measures used in these studies, including those with an agreement level equal to or greater than 5%. This information will be translated into second level categories of the ICF, allowing us to know which of them are more relevant.

The clinical point of view will be captured in a transversal study in which a sample of patients receiving physiotherapy services in primary care will be taken. These patients must make an assessment of the categories present in the ICF checklist. This list will be complemented with the categories of the core sets for musculoskeletal conditions and with those detected in the previous studies. The participants will assign a qualifier to each category, depending on the importance they attach to it. In this study, patients will also be assessed using a generic test that measures the degree of functionality. Aspects such as the presence of cognitive deficit, depression and quality of life will also be considered. The measurement instruments will be selected from the results obtained in the bibliographic review described above. The number of patients required is estimated at 50 individuals belonging to different basic health areas. The data obtained will be analysed and translated into the language of the ICF (second level categories).

The categories derived from the set of previous studies will be compared with those present in the core sets of the ICF for musculoskeletal conditions. Three types of results are expected to be obtained: categories coincident in both groups of data, categories detected in the studies carried out but absent in the core sets; and categories not detected but present in the core sets.

In this way, it will be possible to determine the best way to establish the use of the ICF in the primary care physiotherapy units of SACYL.

Eligibility criteria: Systematic review:

* Inclusion Criteria:
* Primary care studies over adult general population in developed Western countries
* Published in a peer-review journal
* Published since 2009
* Type of publication: random controlled trials, controlled clinical trial, cross-sectional study, observational study and qualitative study
* Exclusion Criteria:
* Studies based solely in specific health problems
* Studies not conducted over general population (some kind of selection based on ethnicity, sex, social class, etc. have been made).
* Studies with hospitalized participants
* Studies published in a language other than English or Spanish

Expert survey:

* Inclusion Criteria:
* Physiotherapists with at least two years of professional experience in primary health care.

Qualitative study

* Inclusion Criteria:
* Treated in a physiotherapy unit during the past year.
* Over 18 years old
* Exclusion Criteria:
* Inability to concentrate for 30 minutes.
* Insufficient knowledge of the Spanish language.

Empirical multicenter study:

* Inclusion Criteria:
* Patients over 18 years referred to a primary care physiotherapy unit
* Exclusion Criteria:
* Inability to concentrate for 30 minutes.
* Insufficient knowledge of the Spanish language.

Primary outcomes:
measure: Most important issues related to functional status, disability and health in the treatment of musculoskeletal conditions in primary care, according to the ICF, reported in the scientific literature.
timeFrame: 2022/05 - 2022/09
measure: Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by physiotherapists in an online survey (expert survey).
timeFrame: 2020/06 - 2021/03
measure: Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by these patients in focus groups (qualitative study).
timeFrame: 2022/05 - 2022/12
measure: Most important issues related to functional status, disability and health in patients treated in physical therapy units for musculoskeletal conditions, assessed by the comprehensive musculoskeletal ICF core set (empirical multicenter study).
timeFrame: 2022/05 - 2023/03
Secondary outcomes:
Other outcomes:
Locations:
city: Ólvega
country: Spain
facility: Ólvega Primary Health Center
state: Soria
Study officials:
affiliation: University of Valladolid
name: María Teresa Mingo Gómez
role: STUDY_DIRECTOR
affiliation: University of Valladolid
name: Héctor Hernández Lázaro
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valladolid
name: Sandra Jiménez del Barrio
role: STUDY_DIRECTOR
affiliation: University of Valladolid
name: Luis Ceballos Laita
role: STUDY_DIRECTOR
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.