Trajectories and Experiences of People With Multimorbidity in Spain (LOXO-MULTIPAP) Project: a Mixed Methods Study

NCT ID: NCT06478745

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

3239950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2027-07-01

Brief Summary

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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

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* 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.

Conditions

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Multimorbidity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Quantitative Aim

Ambispective longitudinal observational study

Retrospective and prospective cohort

Intervention Type OTHER

* Retrospective study: Population-based retrospective cohort study with RWD. Patients ≥60 years old with 2 or more chronic diseases diagnosed before 01/01/2012, users of the public health system of the participating Autonomous Communities, will be included. Those who have had no contact with primary care defined as contact in a medical or nursing consultation in the previous two years (2010-2012) will be excluded.
* Prospective longitudinal observational open cohort study developed in the context of the MULTIPAP and LOXO studies.Patients over 65 years of age with multimorbidity (3 or more chronic pathologies) and polypharmacy (5 or more drugs taken during at least the last 3 months before inclusion in the study) under follow-up from primary care in Madrid, Aragon and Andalusia.

Qualitative Aim

Focus group, semi-structured interviews and Photovoice

Focus group, semi-structured interviews and Photovoice

Intervention Type OTHER

The participants will be people with multimorbidity over 60 years of age recruited from Primary Care centers in Spain. A theoretical sampling will be carried out. Data will be collected through video and audio recordings from a total of 16 focus groups and 20 interviews in 7 regions, and will finally be transcribed for a triangulated thematic analysis. Two groups will be carried out with participation-action research methodology - Photovoice.

Systematic Review Aim

Systematic literature review on the effectiveness of interventions on training, multimorbidity and polypharmacy in health professionals.

Systematic review

Intervention Type OTHER

No patient recruitment required

Interventions

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Retrospective and prospective cohort

* Retrospective study: Population-based retrospective cohort study with RWD. Patients ≥60 years old with 2 or more chronic diseases diagnosed before 01/01/2012, users of the public health system of the participating Autonomous Communities, will be included. Those who have had no contact with primary care defined as contact in a medical or nursing consultation in the previous two years (2010-2012) will be excluded.
* Prospective longitudinal observational open cohort study developed in the context of the MULTIPAP and LOXO studies.Patients over 65 years of age with multimorbidity (3 or more chronic pathologies) and polypharmacy (5 or more drugs taken during at least the last 3 months before inclusion in the study) under follow-up from primary care in Madrid, Aragon and Andalusia.

Intervention Type OTHER

Focus group, semi-structured interviews and Photovoice

The participants will be people with multimorbidity over 60 years of age recruited from Primary Care centers in Spain. A theoretical sampling will be carried out. Data will be collected through video and audio recordings from a total of 16 focus groups and 20 interviews in 7 regions, and will finally be transcribed for a triangulated thematic analysis. Two groups will be carried out with participation-action research methodology - Photovoice.

Intervention Type OTHER

Systematic review

No patient recruitment required

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 60 years or older
* 2 or more chronic diseases

Exclusion Criteria

\- Not having used the national health system in the last year
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PI. Bernardino Oliva. Instituto Investigación Sanitaria Illes Balears

UNKNOWN

Sponsor Role collaborator

PI. Concepción Violan. Fundacion Jordi Gol i Gurina

UNKNOWN

Sponsor Role collaborator

PI Antonio Gimeno. Instituto de Investigación Sanitaria Aragón.

UNKNOWN

Sponsor Role collaborator

PI. Rafael Rotaeche. Instituto Investigación Bioguipuzcoa. Osakidetza

UNKNOWN

Sponsor Role collaborator

PI. Francisca Leiva. Instituto de Investigacion Biomedica de Malaga.

UNKNOWN

Sponsor Role collaborator

CI. Julian Librero. Navarra Biomed. Servicio Navarro de Salud

UNKNOWN

Sponsor Role collaborator

Fundación Investigacion en Innovacion Biomédica en Atención Primaria FIIBAP

UNKNOWN

Sponsor Role collaborator

Instituto de Investigación Sanitaria Gregorio Marañón

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role collaborator

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role lead

Responsible Party

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Isabel Del Cura-Gonzalez

Principal - Coordinator researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabel del Cura González, PhD,MD

Role: STUDY_DIRECTOR

Gerencia Asistencial de Atención Primaria

Locations

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Isabel del Cura González

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI22/00768 Isabel del Cura

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI22/01651 Francisca Leiva

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI22/00701 Antonio Gimeno

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI22/01684 Bernardino Oliva

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI22/01398 Concepción Violan

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI22/01665 Rafael Rotaeche

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20230033

Identifier Type: -

Identifier Source: org_study_id

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