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

Trajectories and Experiences of Patients With Multimorbidity in the National Health Service of Spain: a Mixed Methods Study (LOXO-MULTIPAP)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multimorbidity
• Intervention / Treatment: Other: Retrospective and prospective cohort; Other: Focus group, semi-structured interviews and Photovoice; Other: Systematic review

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.

• Study Type: Observational
• Enrollment (Estimated): 3239950

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28035
    • Isabel del Cura González

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion criteria:

• 60 years or older
• 2 or more chronic diseases

Exclusion criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Quantitative Aim; Ambispective longitudinal observational study	Other: 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.
Qualitative Aim; Focus group, semi-structured interviews and Photovoice	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.
Systematic Review Aim; Systematic literature review on the effectiveness of interventions on training, multimorbidity and polypharmacy in health professionals.	Other: Systematic review; No patient recruitment required

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Morisky-Green (Patients who answer NO to all four questions are considered compliant with treatment and those who answer YES to one or more are considered non-compliant)	Baseline
Social support	Dukes-Unk-11(This questionnaire consists of 11 items and a Likert-type response scale. The score range is between 11 and 55 points. A score equal to or greater than 32 indicates normal support, while a score of less than 32 indicates low perceived social support)	Baseline
Functioning and disability	WHODAS (It is composed of 36 items that evaluate the following 6 dimensions. The overall score runs a scale from 0 to 100, with higher values indicating greater disability)	Baseline/ 1 year
Health releated quality of life	Euroqol 5D-5L (It consists of 2 parts - The EQ-5D descriptive system and the Visual Analog Scale (VAS). Scale (VAS). In the VAS the individual scores his or her health between two extremes, 0 and 100, the worst and the best state of health imaginable. imaginable)	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Years	Baseline
Sex	Male/Female	Baseline
Country	Country of origin	Baseline
Deprivation Index	MEDEA (Values from 1 to 5. Higher values indicate a more unfavorable socioeconomic situation)	Baseline

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Collaborators: Instituto de Investigación Sanitaria Gregorio Marañón; Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina; Fundación Investigacion en Innovacion Biomédica en Atención Primaria FIIBAP; PI. Bernardino Oliva. Instituto Investigación Sanitaria Illes Balears; PI. Concepción Violan. Fundacion Jordi Gol i Gurina; PI Antonio Gimeno. Instituto de Investigación Sanitaria Aragón.; PI. Rafael Rotaeche. Instituto Investigación Bioguipuzcoa. Osakidetza; PI. Francisca Leiva. Instituto de Investigacion Biomedica de Malaga.; CI. Julian Librero. Navarra Biomed. Servicio Navarro de Salud
• Investigators: Study Director: Isabel del Cura González, PhD,MD, Gerencia Asistencial de Atención Primaria

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Primary Health Care; Cluster; Qualitative study; Multimorbidity; Shared decision-making; Photovoice; Patterns; Mixed-methods; Semi-structured interviews; Trajectories; Discussion group
• Other Study ID Numbers: 20230033; PI22/00768 Isabel del Cura (Other Grant/Funding Number: Instituto Salud Carlos III-European Regional Develop. Found); PI22/01651 Francisca Leiva (Other Grant/Funding Number: Instituto Salud Carlos III-European Regional Development F.); PI22/00701 Antonio Gimeno (Other Grant/Funding Number: Instituto Salud Carlos III-European Regional Develop. Found); PI22/01684 Bernardino Oliva (Other Grant/Funding Number: Instituto Salud Carlos III-European Regional Develop. Found); PI22/01398 Concepción Violan (Other Grant/Funding Number: Instituto Salud Carlos III-European Regional Develop. Found); PI22/01665 Rafael Rotaeche (Other Grant/Funding Number: Instituto Salud Carlos III-European Regional Develop. Found)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No