Exploring the Multimorbidity Burden in Primary Care in Romania

NCT ID: NCT06876558

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2025-06-01

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

Detailed Description

Background and Rationale Multimorbidity, defined as the presence of two or more chronic conditions in the same individual, is a growing concern in global healthcare. It significantly impacts healthcare systems, increasing hospital admissions, prolonging hospital stays, and elevating healthcare costs. In the European Union, it is estimated that at least 50 million people suffer from multimorbidity, and this number is expected to rise with aging populations (Rijken et al., 2013).

Patients with multimorbidity experience worse health outcomes compared to those with a single chronic disease, including higher mortality rates, reduced functional capacity, lower health-related quality of life (HRQoL), and a greater prevalence of depression (Menotti et al., 2001, Christine Vogeli et al., 2007). Managing multimorbidity is particularly complex due to polypharmacy and the risk of adverse drug interactions. The current disease-specific clinical guidelines, which primarily focus on single-disease management, often fail to address the multifaceted needs of multimorbid patients (Kristen Anderson et al., 2017).

State of the Art Multimorbidity research has been widely conducted in high-income Western European countries and North America, leading to established frameworks for care models, clinical guidelines, and integrated management strategies. However, research on multimorbidity in Eastern European healthcare systems remains scarce. Romania, in particular, lacks comprehensive data on multimorbidity prevalence, its impact on primary care, and physicians' perspectives on its management.

In many healthcare systems, general practitioners (GPs) are at the frontline of multimorbidity management, yet they face substantial challenges, including limited consultation time, scarce resources, and difficulties in coordinating with specialists. Multimorbid patients require personalized care plans, often leading to guideline deviations that may cause physician anxiety about potential medical and legal repercussions. Understanding how Romanian primary care physicians navigate these challenges is essential to improving patient outcomes and optimizing healthcare delivery.

Knowledge Gap

Despite the increasing prevalence of multimorbidity in Romania, there is little empirical evidence regarding:

The proportion of multimorbid patients seen in primary care. The specific challenges physicians face in managing these patients. The role of interdisciplinary collaboration and the barriers to integrated care.

The balance between defensive medicine and proactive deprescription strategies. The impact of multimorbidity on physicians' clinical decision-making and their adherence to single-disease guidelines.

By addressing these gaps, this study aims to provide valuable insights into how multimorbidity affects clinical practice in Romania and identify potential improvements in patient-centered care.

Objectives

This study aims to explore the impact of multimorbidity on primary care physicians in Romania, focusing on:

The prevalence of multimorbidity in ambulatory care. The challenges faced by GPs, including time constraints, polypharmacy, and resource limitations.

Difficulties in interdisciplinary collaboration and care coordination. The use of defensive vs. proactive medicine in multimorbidity management. The influence of multimorbidity on adherence to clinical guidelines and physician decision-making.

Potential solutions to improve multimorbidity management, including extending consultation times, enhancing interdisciplinary collaboration, and integrating multimorbidity-focused guidelines into primary care.

Methods Study Design This is a cross-sectional survey-based study conducted among primary care physicians and ambulatory care specialists in Romania. The survey will assess multimorbidity's impact on clinical decision-making, patient management strategies, and interdisciplinary collaboration. A semi-qualitative component will be included to gather in-depth insights from physicians.

Study Population

Inclusion Criteria:

Active medical practice in Romania. Experience in managing patients with multimorbidity. Willingness to participate in the study. Exclusion Criteria: None. Data Collection Survey Distribution: The survey will be disseminated electronically and in print among primary care physicians in Romania and the Balkan region.

Survey Components:

Demographic information: Age, gender, years of experience, practice setting. Clinical workload: Average number of patients seen per day, proportion of multimorbid patients.

Management strategies: Approaches to polypharmacy, deprescription practices, time allocation for multimorbid patients.

Physician perceptions: Challenges faced, levels of comfort with guideline deviations, attitudes toward interdisciplinary collaboration.

Data Processing and Analysis: Quantitative data will be analyzed using descriptive statistics, while qualitative responses will be thematically analyzed.

Outcome Measures

Primary Outcomes:

Proportion of multimorbidity, single morbidity, and non-comorbid patients in ambulatory care.

Identification of challenges related to consultation time, treatment complexity, and polypharmacy.

Assessment of preventive strategies (smoking cessation, alcohol reduction, diet, physical activity, sleep, and social engagement).

Secondary Outcomes:

Barriers to interdisciplinary collaboration and care coordination. Patterns of defensive medicine versus active deprescription practices. Levels of physician anxiety related to adherence to clinical guidelines. Expected Impact

This study will provide evidence on the prevalence and impact of multimorbidity in Romanian primary care. It aims to inform policymakers, healthcare administrators, and medical educators on how to improve multimorbidity management through:

Better allocation of resources and consultation time. Training programs focused on multimorbidity care strategies. Development of integrated care pathways that support interdisciplinary collaboration.

By addressing the challenges faced by primary care physicians, this study will contribute to a more effective and patient-centered approach to multimorbidity management in Romania

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Transilvania University of Brasov

OTHER

Sponsor Role: collaborator

Internist.Ro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea NECULAU, MD

Role: STUDY_CHAIR

Universitatea Transilvania Brasov

Silvia Sovaila, MD

Role: PRINCIPAL_INVESTIGATOR

Universitatea Transilvania Brasov

Adrian PURCAREA, MD

Role: STUDY_DIRECTOR

Internist.Ro

Locations

Universitatea Transilvania Brasov School of Medicine

Brasov, , Romania

Countries

Romania

Central Contacts

Adrian PURCAREA, MD

Role: CONTACT

adrian.purcarea@interinst.ro

0040751141636

Silvia SOVAILA

Role: CONTACT

silvia.sovaila@unitbv.ro

0040753020253

Facility Contacts

Andrea Neculau, Professor of Medicine

Role: primary

f-med@unitbv.ro

0040268 412185

References

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)

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 29088989 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11438408 (View on PubMed)

Other Identifiers

A003

Identifier Type: -

Identifier Source: org_study_id