MultimorbidityFDPMNCT03088982
Preventing Decompensation Among Multimorbid Outpatients in Residential Care. A Cohort Study With a Six-month Follow-up.
An observational study of Multimorbidity, run by University Hospital, Brest.
Trial summary
Background :The European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Questionnaire
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population included all multimorbid patients (according to the EGPRN definition of multimorbidity) who met 12 FPs in the Lanmeur residential care home in the county of Finistere (in north-west France) from July 2014 to December 2014. These FPs were drawn from those physicians associated with the Lanmeur residential care home.
Inclusion criteria were patients meeting the criteria for the definition of multimorbidity according to the EGPRN definition: any combination of chronic disease with at least another disease (acute or chronic) or a bio psychosocial factor (associated or not) or somatic risk factor.
Exclusion criteria were patients not meeting the criteria of the definition of multimorbidity, the inability to follow the study over time, patients on legal protection, patients for whom survival was estimated at less than three months.
About this study
Official title: Running Title: The Patient's Pain Seems to be a Reliable Risk Factor for Decompensation Among Multimorbid Patients in Residential Care.
Background :The European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. This survey assessed which criteria in the EGPRN concept of multimorbidity could detect decompensating patients in residential care within a primary care cohort at a 6-month follow-up.
Method: Family Physicians included all multimorbid patients encountered in their residential care homes from July to December 2014. Inclusion criteria were those of the EGPRN definition of Multimorbidity. Exclusion criteria were patients under legal protection and those unable to complete the 2-year follow-up. Decompensation was defined as the occurrence of death or hospitalization for more than seven days. Statistical analysis was undertaken with uni- and multivariate analysis at a 6-month follow-up using a combination of approaches including both automatic classification and expert decision making. A Multiple Correspondence Analysis (MCA) and a Hierarchical Clustering on Principal Components (HCPC) confirmed the consistency of the results. Finally a logistic regression was performed in order to identify and quantify risk factors for decompensation.
Read the detailed description
The concept of multimorbidity was first published in 1976. Multimorbidity has been defined by the World Health Organization (WHO) as people being affected by two or more chronic health conditions. Multimorbidity is a very interesting and challenging concept particularly for Family Medicine (FM), given the increasing prevalence of chronic illness in an aging population across all developed countries. It is closely related to a global or comprehensive view of the patient, which is a core competency of FM, as defined, for instance, by the World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (WONCA). It is a global 'functional' view (useful for Long-Term Care) versus a 'disease' centered point of view (useful for acute care).
The European General Practice Research Network (EGPRN) has created a research agenda specifically designed for methodological and instrumental research, which includes the development of primary care epidemiology, focusing on patient-centered health. A comprehensive definition of the concept of multimorbidity (i.e. one which is both understandable and usable for further collaborative research) was an important objective for this research network. The objective was to help researchers in FM to investigate the complexity of patients' conditions and their overall impact on patients' health. This concept of multimorbidity could be an additional tool for Family Physicians (FPs), enabling them to prevent decompensation.
A research team, including 9 national groups, all active within the EGPRN, has created a research community for the purpose of clarifying the concept of multimorbidity for FM throughout Europe. This group produced a comprehensive definition of the concept of multimorbidity through a systematic review of literature. This concept was translated into most European languages for use in further collaborative research. Finally, it was validated using qualitative research throughout Europe and a specific research agenda was issued. The EGPRN concept of multimorbidity included a set of different variables assessing patients' multimorbidity, multimorbidity modulating factors and multimorbidity consequences.
Decompensation (i.e. death or hospitalization in acute care) is a challenge for FM as FPs, being familiar with their patient's health status, could miss tiny factors which, if noticed, could help to prevent decompensation. A predictive model that could be integrated into their clinical practice could help them to prevent decompensation and avoid serious health outcomes for their patients. The EGPRN concept of multimorbidity was considered highly suitable for a purpose such as this. It could lead to a usable model for preventing decompensation.
The French population is aging, with one in three people over 60 years of age in 2050. Consequently, the number of dependent patients, some requiring institutionalization in Care homes (CHs), is growing. Patients residing in CHs are included in the EGPRN definition of multimorbidity. In France, as in most European countries, patients in residential care are treated by FPs.
The purpose of this research was to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating patients in residential care within a primary care cohort at a 6-month follow-up.
- Conditions
- Multimorbidity
- Being tested
- Questionnaire
- Keywords
- Family Medicine, multimorbidity, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
FPs who had agreed to participate worked according to the following plan: first, the multimorbid patient was asked to give his/her consent to participate in the study once the terms had been explained to him/her. After that, FPs completed a questionnaire about their patient.
The purpose of this questionnaire was to explore potential decompensation risk factors within the themes and subthemes of multimorbidity.
| Study group | Role | What they receive |
|---|---|---|
| Lanmeur multimorbid patients | All multimorbid patients who met 12 FPs in the Lanmeur residential care home in the county of Finistere (in north-west France) from July 2014 to December 2014. These FPs were drawn from those physicians associated with the Lanmeur residential care home. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the multimorbidity criteria
The purpose of this research was to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating patients in residential care within a primary care cohort at a 6-month follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startJun 2014
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- ERCR SPURBO, Unité INSERM 1078, SFR 148 ScInBioS, Brest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088982
- Sponsor's protocol ID
- FDPM - 05122011
- Acronym
- FDPM
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Running Title: The Patient's Pain Seems to be a Reliable Risk Factor for Decompensation Among Multimorbid Patients in Residential Care.
- ClinicalTrials.gov ID
- NCT03088982
- Acronym / sponsor ID
- FDPM / FDPM - 05122011
- Conditions
- Multimorbidity
- Keywords
- Family Medicine, multimorbidity, prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- ERCR SPURBO, Unité INSERM 1078, SFR 148 ScInBioS, Brest
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Mar 2017 (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.
Background :The European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. This survey assessed which criteria in the EGPRN concept of multimorbidity could detect decompensating patients in residential care within a primary care cohort at a 6-month follow-up.
Method: Family Physicians included all multimorbid patients encountered in their residential care homes from July to December 2014. Inclusion criteria were those of the EGPRN definition of Multimorbidity. Exclusion criteria were patients under legal protection and those unable to complete the 2-year follow-up. Decompensation was defined as the occurrence of death or hospitalization for more than seven days. Statistical analysis was undertaken with uni- and multivariate analysis at a 6-month follow-up using a combination of approaches including both automatic classification and expert decision making. A Multiple Correspondence Analysis (MCA) and a Hierarchical Clustering on Principal Components (HCPC) confirmed the consistency of the results. Finally a logistic regression was performed in order to identify and quantify risk factors for decompensation.
Detailed description
The concept of multimorbidity was first published in 1976. Multimorbidity has been defined by the World Health Organization (WHO) as people being affected by two or more chronic health conditions. Multimorbidity is a very interesting and challenging concept particularly for Family Medicine (FM), given the increasing prevalence of chronic illness in an aging population across all developed countries. It is closely related to a global or comprehensive view of the patient, which is a core competency of FM, as defined, for instance, by the World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (WONCA). It is a global 'functional' view (useful for Long-Term Care) versus a 'disease' centered point of view (useful for acute care).
The European General Practice Research Network (EGPRN) has created a research agenda specifically designed for methodological and instrumental research, which includes the development of primary care epidemiology, focusing on patient-centered health. A comprehensive definition of the concept of multimorbidity (i.e. one which is both understandable and usable for further collaborative research) was an important objective for this research network. The objective was to help researchers in FM to investigate the complexity of patients' conditions and their overall impact on patients' health. This concept of multimorbidity could be an additional tool for Family Physicians (FPs), enabling them to prevent decompensation.
A research team, including 9 national groups, all active within the EGPRN, has created a research community for the purpose of clarifying the concept of multimorbidity for FM throughout Europe. This group produced a comprehensive definition of the concept of multimorbidity through a systematic review of literature. This concept was translated into most European languages for use in further collaborative research. Finally, it was validated using qualitative research throughout Europe and a specific research agenda was issued. The EGPRN concept of multimorbidity included a set of different variables assessing patients' multimorbidity, multimorbidity modulating factors and multimorbidity consequences.
Decompensation (i.e. death or hospitalization in acute care) is a challenge for FM as FPs, being familiar with their patient's health status, could miss tiny factors which, if noticed, could help to prevent decompensation. A predictive model that could be integrated into their clinical practice could help them to prevent decompensation and avoid serious health outcomes for their patients. The EGPRN concept of multimorbidity was considered highly suitable for a purpose such as this. It could lead to a usable model for preventing decompensation.
The French population is aging, with one in three people over 60 years of age in 2050. Consequently, the number of dependent patients, some requiring institutionalization in Care homes (CHs), is growing. Patients residing in CHs are included in the EGPRN definition of multimorbidity. In France, as in most European countries, patients in residential care are treated by FPs.
The purpose of this research was to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating patients in residential care within a primary care cohort at a 6-month follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lanmeur multimorbid patients | – | Other: QuestionnaireAll multimorbid patients who met 12 FPs in the Lanmeur residential care home in the county of Finistere (in north-west France) from July 2014 to December 2014. These FPs were drawn from those physicians associated with the Lanmeur residential care home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included all multimorbid patients (according to the EGPRN definition of multimorbidity) who met 12 FPs in the Lanmeur residential care home in the county of Finistere (in north-west France) from July 2014 to December 2014. These FPs were drawn from those physicians associated with the Lanmeur residential care home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireFPs who had agreed to participate worked according to the following plan: first, the multimorbid patient was asked to give his/her consent to participate in the study once the terms had been explained to him/her. After that, FPs completed a questionnaire about their patient. The purpose of this questionnaire was to explore potential decompensation risk factors within the themes and subthemes of multimorbidity. | Other | Lanmeur multimorbid patients |
Primary outcome
Evaluation of the multimorbidity criteria
Time frame: 6 months
The purpose of this research was to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating patients in residential care within a primary care cohort at a 6-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity, run by University Hospital, Brest.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the multimorbidity criteria (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2017.