Clinical trial NCT06478745: Trajectories and Experiences of People With Multimorbidity in Spain (LOXO-MULTIPAP) Project: a Mixed Methods Study
Official title: Trajectories and Experiences of Patients With Multimorbidity in the National Health Service of Spain: a Mixed Methods Study (LOXO-MULTIPAP)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multimorbidity
Keywords: Multimorbidity
Primary Health Care
Trajectories
Mixed-methods
Patterns
Qualitative study
Discussion group
Semi-structured interviews
Photovoice
Shared decision-making
Cluster
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: PI. Bernardino Oliva. Instituto Investigación Sanitaria Illes Balears
name: PI. Concepción Violan. Fundacion Jordi Gol i Gurina
name: PI Antonio Gimeno. Instituto de Investigación Sanitaria Aragón.
name: PI. Rafael Rotaeche. Instituto Investigación Bioguipuzcoa. Osakidetza
name: PI. Francisca Leiva. Instituto de Investigacion Biomedica de Malaga.
name: CI. Julian Librero. Navarra Biomed. Servicio Navarro de Salud
name: Fundación Investigacion en Innovacion Biomédica en Atención Primaria FIIBAP
name: Instituto de Investigación Sanitaria Gregorio Marañón
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
First posted: 2024-06-27
Enrollment: 3239950
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patientes aged 60 years or older with 2 or more chronic diseases diagnosed before 2012-01-01. Population registered at Primary Health Centres in Spain.

Sampling Method: Not Applicable

Brief summary: The overall objective of the study is to analyze the evolution of multimorbidity, its most relevant patterns and trajectories in the Spanish National Health System population, from 2012 to 2022, and to analyze the factors that determine it, as well as the experience of professionals and patients in navigating the health system and in shared decision making.

Multimorbidity trajectories can help identify homogeneous groups of individuals with similar needs and prognoses, and help practitioners and health systems to personalize clinical interventions and preventive strategies. Capturing this dynamism is the only way to better understand the natural history of multimorbidity and shed light on hitherto unexplained findings.

Detailed description: * Design: Mixed-method study.

  * Quantitative study: retrospective and prospective observational study. It integrates demographic and clinical information from electronic medical records and clinical-administrative databases. It involves the harmonisation of the cohorts of users of the public health system of the 7 participating regions.
  * Qualitative study with a phenomenological and ethnographic approach using focus group techniques, semi-structured interviews and Photovoice to find out the perspective of patients and professionals in shared decision-making.
  * Systematic literature review on the effectiveness of interventions on training, multimorbidity and polypharmacy in health professionals.
* Analysis:

  * Quantitative study: Cluster, network and trajectory analysis
  * Qualitative study: Thematic content analysis that will be triangulated among the members of the research team. Meanings will be interpreted and an explanatory framework will be created with the contributions of each type of informant.

Eligibility criteria: Inclusion criteria:

* 60 years or older
* 2 or more chronic diseases

Exclusion criteria:

- Not having used the national health system in the last year

Primary outcomes:
measure: Multimorbidity
timeFrame: Baseline
measure: Death
timeFrame: Start date 31/12/2012, 1 year
measure: Drugs
timeFrame: 1 year
measure: Use of service
timeFrame: 1 year
measure: Morbidity
timeFrame: Baseline/ 1 year
measure: Frailty
timeFrame: Baseline/ 1 year
Secondary outcomes:
measure: Adherence
timeFrame: Baseline
measure: Social support
timeFrame: Baseline
measure: Functioning and disability
timeFrame: Baseline/ 1 year
measure: Health releated quality of life
timeFrame: Baseline
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Country
timeFrame: Baseline
measure: Deprivation Index
timeFrame: Baseline
Locations:
city: Madrid
country: Spain
facility: Isabel del Cura González
Study officials:
affiliation: Gerencia Asistencial de Atención Primaria
name: Isabel del Cura González, PhD,MD
role: STUDY_DIRECTOR
References: