Exploring the Multimorbidity Burden in Primary Care in Romania

NCT06876558 | Not Yet Recruiting

• 1 other identifier: A003
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Multimorbidity, the coexistence of two or more chronic conditions, is a growing challenge in primary care, significantly impacting healthcare systems worldwide. Its prevalence is rising, particularly among socioeconomically disadvantaged populations, leading to increased healthcare utilization, polypharmacy, and fragmented care. Current clinical guidelines primarily address single-disease management, failing to provide comprehensive strategies for multimorbid patients. Although multimorbidity has been extensively studied in Western Europe and North America, data on its burden in Romania and other Eastern European countries remain scarce. There is limited knowledge on how primary care physicians (PCPs) in Romania perceive and manage multimorbidity, particularly regarding clinical decision-making, interdisciplinary collaboration, and adherence to treatment guidelines. This cross-sectional study aims to explore the impact of multimorbidity on Romanian PCPs, assessing their challenges in managing complex patients, their clinical and therapeutic approaches, and their level of comfort with deprescription and guideline adaptation. We will conduct a nationwide survey among primary care physicians and ambulatory specialists to evaluate the prevalence of multimorbidity in their practice, the difficulties they encounter, and potential strategies to improve care delivery. Key outcomes include the identification of multimorbidity prevalence in ambulatory settings, challenges related to consultation time and treatment complexity, barriers to interdisciplinary collaboration, and the balance between defensive and proactive medicine. Findings will provide valuable insights to guide policy changes, enhance clinical training, and promote patient-centered approaches in primary care

Conditions

Multimorbidity; General Practice (GP), Primary Care Settings; Specialist Referral

Keywords

multimorbidity; priamary care; specialized care

Outcome Measures

Primary Outcomes (3)

• Proportion of multimorbidity

  Prevalence of multimorbidity in primary care (percentage of patients)

  baseline

• Proportion of single morbidity

  Proportion of single morbidity (percentage) in primary care practice

  baseline

• Proportion of non comorbid patients

  Proportion percentage out of total) of non comorbid patients in primary care versus specialized ambulatory care according to specialty.

  Baseline

Study Arms (2)

Primary Care Physicians (PCPs)

General practitioners (GPs) actively working in primary care settings. Responsible for managing multimorbid patients in ambulatory settings. Expected proportion: MHalf of the population

Ambulatory Care Specialists

Specialists involved in outpatient management of chronic diseases (e.g., internal medicine, cardiology, endocrinology). Provide secondary care and interact with PCPs in multimorbidity management.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of primary care physicians (PCPs) and ambulatory care specialists actively working in Romania. Participants will be recruited from urban and rural primary care clinics, outpatient specialist practices, and ambulatory care centers across various regions of the country. The survey will be distributed through national and local medical associations, professional networks. The expected prevalence of multimorbidity is estimated at 20%. This requires a minimum of 246 completed surveys to achieve a 95% confidence level with a 5% margin of error. This population will represent a diverse group of healthcare professionals who are directly involved in the management of multimorbid patients in outpatient settings, ensuring a comprehensive understanding of the challenges and strategies associated with multimorbidity care in Romania.

You may qualify if:

• Active AMBULATORY CARE medical practice in Romania.
• Experience in managing patients with multimorbidity.
• Willingness to participate in the study.

You may not qualify if:

• None

Sponsors & Collaborators

• Internist.Ro: lead
• Transilvania University of Brasov: collaborator

Study Sites (1)

Universitatea Transilvania Brasov School of Medicine

Brasov, 500019, Romania

Location

Related Publications (3)

• Rijken,M. and Struckmann,V. and Dyakova,M. and Melchiorre, M. G. and Rissanen,S. and Ginneken,E. van, 20133386107, English, Journal article, Belgium, 1356-1030, 19, (3), Brussels, Eurohealth, (29-31), European Observatory on Health Systems and Policies, ICARE4EU: improving care for people with multiple chronic conditions in Europe., (2013)

  BACKGROUND

• Anderson K, Foster M, Freeman C, Luetsch K, Scott I. Negotiating "Unmeasurable Harm and Benefit": Perspectives of General Practitioners and Consultant Pharmacists on Deprescribing in the Primary Care Setting. Qual Health Res. 2017 Nov;27(13):1936-1947. doi: 10.1177/1049732316687732. Epub 2017 Jan 12.

  PMID: 29088989 BACKGROUND

• Menotti A, Mulder I, Nissinen A, Giampaoli S, Feskens EJ, Kromhout D. Prevalence of morbidity and multimorbidity in elderly male populations and their impact on 10-year all-cause mortality: The FINE study (Finland, Italy, Netherlands, Elderly). J Clin Epidemiol. 2001 Jul;54(7):680-6. doi: 10.1016/s0895-4356(00)00368-1.

  PMID: 11438408 BACKGROUND

Study Officials

• Andrea NECULAU, MD

  Universitatea Transilvania Brasov

  STUDY CHAIR

• Silvia Sovaila, MD

  Universitatea Transilvania Brasov

  PRINCIPAL INVESTIGATOR

• Adrian PURCAREA, MD

  Internist.Ro

  STUDY DIRECTOR

Central Study Contacts

Adrian PURCAREA, MD

CONTACT

0040751141636; adrian.purcarea@interinst.ro

Silvia SOVAILA

CONTACT

0040753020253; silvia.sovaila@unitbv.ro

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 20, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: April 2025-April 2030
• Access Criteria: Eligibility for Data Access: Data will be shared with qualified researchers affiliated with academic institutions, healthcare organizations, or research institutions conducting studies related to multimorbidity, primary care, or health services research. The request must specify the intended scientific objectives, planned statistical analyses, and potential contributions to the field. Proposals must align with ethical and legal standards for data privacy and patient confidentiality. Data Sharing Mechanism: Researchers must submit a formal request detailing their proposed analyses, methodologies, and intended outcomes. Requests can be submitted via email to the study sponsor or principal investigator, along with the necessary documentation.

Locations

RO (1)