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

NCT06478745 | Enrolling By Invitation

• 7 other identifiers: 20230033PI22/00768 Isabel del CuraPI22/01651 Francisca LeivaPI22/00701 Antonio GimenoPI22/01684 Bernardino OlivaPI22/01398 Concepción ViolanPI22/01665 Rafael Rotaeche
• Study Type: observational
• Target: 3,239,950
• Locations: 1 country
• Sites: 1

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.

Conditions

Multimorbidity

Keywords

Multimorbidity; Primary Health Care; Trajectories; Mixed-methods; Patterns; Qualitative study; Discussion group; Semi-structured interviews; Photovoice; Shared decision-making; Cluster

Outcome Measures

Primary Outcomes (6)

• Multimorbidity

  Presence of two or more diagnoses of any of the 60 diseases categorised by the Swedish National Study of Ageing and Care (SNAC-K20) (It is a classification, not a scale)

  Baseline

• Death

  Death and abandonment: the occurrence of this event will be measured, regardless of the cause

  Start date 31/12/2012, 1 year

• Drugs

  300 ATC Swedish National Study of Ageing and Care (SNAC-K20) 8It is a classification, not a scale)

  1 year

• Use of service

  Primary Care medical/nursing visits, emergencies, referrals, admissions

  1 year

• Morbidity

  Defined with ICD-10, laboratory defined in the Swedish National Study of Ageing and Care (SNAC-K20). It is a classification, not a scale

  Baseline/ 1 year

• Frailty

  EFRAIL (It consists of 5 dichotomous questions. Scoring from 0 to 5. Interpretation: * Probable frailty: 3 to 5 points. * Probable pre-fragility: 1 to 2 points. * No fragility or robustness: 0 points)

  Baseline/ 1 year

Secondary Outcomes (4)

• Adherence

  Baseline

• Social support

  Baseline

• Functioning and disability

  Baseline/ 1 year

• Health releated quality of life

  Baseline

Other Outcomes (4)

• Age

  Baseline

• Sex

  Baseline

• Country

  Baseline

Study Arms (3)

Quantitative Aim

Ambispective longitudinal observational study

Other: Retrospective and prospective cohort

Qualitative Aim

Focus group, semi-structured interviews and Photovoice

Other: Focus group, semi-structured interviews and Photovoice

Systematic Review Aim

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

Other: Systematic review

Interventions

Retrospective and prospective cohort 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.

Quantitative Aim

Focus group, semi-structured interviews and Photovoice 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.

Qualitative Aim

Systematic review OTHER

No patient recruitment required

Systematic Review Aim

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years or older
• or more chronic diseases

You may not qualify if:

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

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• PI. Bernardino Oliva. Instituto Investigación Sanitaria Illes Balears: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• PI Antonio Gimeno. Instituto de Investigación Sanitaria Aragón.: collaborator
• PI. Rafael Rotaeche. Instituto Investigación Bioguipuzcoa. Osakidetza: collaborator
• PI. Francisca Leiva. Instituto de Investigacion Biomedica de Malaga.: collaborator
• CI. Julian Librero. Navarra Biomed. Servicio Navarro de Salud: collaborator
• Fundación Investigacion en Innovacion Biomédica en Atención Primaria FIIBAP: collaborator
• Instituto de Investigación Sanitaria Gregorio Marañón: collaborator

Study Sites (1)

Isabel del Cura González

Madrid, 28035, Spain

Location

MeSH Terms

Interventions

Retrospective Studies; Focus Groups

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Data Collection

Study Officials

• Isabel del Cura González, PhD,MD

  Gerencia Asistencial de Atención Primaria

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal - Coordinator researcher

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 27, 2024
• Study Start: June 30, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

ES (1)