MultimorbidityMULTIMORB-PC-RNCT06876558
Exploring the Multimorbidity Burden in Primary Care in Romania
An observational study of Multimorbidity and General Practice (GP), Primary Care Settings, run by Internist.Ro at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multimorbidity, General Practice (GP), Primary Care Settings, Specialist Referral
- How many people
- 500 participants
- Where
- 1 siteRomania
- Study dates
- 20 Mar 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Active AMBULATORY CARE medical practice in Romania.
- Experience in managing patients with multimorbidity.
- Willingness to participate in the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Universitatea Transilvania Brasov School of Medicine
Brasov, 500019
Andrea Neculau, Professor of Medicine, 0040268 412185, f-med@unitbv.ro
About this study
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.
Read more
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
Read the 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
- Keywords
- multimorbidity, priamary care, specialized care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of multimorbidity
Prevalence of multimorbidity in primary care (percentage of patients)
Measured: baseline
Proportion of single morbidity
Proportion of single morbidity (percentage) in primary care practice
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Internist.Ro
- Sponsor type
- University, hospital or other
- Collaborators
- Transilvania University of Brasov
- Responsible party
- Sponsor
- Investigators
- Andrea NECULAU, MD, Study chair, Universitatea Transilvania BrasovSilvia Sovaila, MD, Principal investigator, Universitatea Transilvania BrasovAdrian PURCAREA, MD, Study director, Internist.Ro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876558
- Sponsor's protocol ID
- A003
- Acronym
- MULTIMORB-PC-R
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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)
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.
PubMed 29088989Menotti 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.
PubMed 11438408
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Multimorbidity Burden in Primary Care in Romania
- ClinicalTrials.gov ID
- NCT06876558
- Acronym / sponsor ID
- MULTIMORB-PC-R / A003
- Keywords
- multimorbidity, priamary care, specialized care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Internist.RoUniversity, hospital or other
- Collaborators
- Transilvania University of Brasov
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Active AMBULATORY CARE medical practice in Romania.
- Experience in managing patients with multimorbidity.
- Willingness to participate in the study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of multimorbidity
Time frame: baseline
Prevalence of multimorbidity in primary care (percentage of patients)
Proportion of single morbidity
Time frame: baseline
Proportion of single morbidity (percentage) in primary care practice
Proportion of non comorbid patients
Time frame: Baseline
Proportion percentage out of total) of non comorbid patients in primary care versus specialized ambulatory care according to specialty.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Results publicationRijken,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)
- Results publication: PubMed 29088989Anderson 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.
- Results publication: PubMed 11438408Menotti 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea NECULAU, MD study chair
Universitatea Transilvania Brasov
Silvia Sovaila, MD principal investigator
Universitatea Transilvania Brasov
Adrian PURCAREA, MD study director
Internist.Ro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity and General Practice (GP), Primary Care Settings, run by Internist.Ro at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrian PURCAREA, MD (0040751141636, adrian.purcarea@interinst.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of multimorbidity (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06876558, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.