- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03116061
The Reported Frequency of FP Visits and Family Difficulties Should Alert FPs and Help Them to Prevent Severe Outcomes in Multimorbid Outpatients
The Frequency of Family Physician Visits and the Extent of Family Difficulties Reported by Family Physicians Appear to be Decompensation Risk Factors for Multimorbid Outpatients in a Primary Care Feasibility Study
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 definition was tested as a model to assess decompensation in multimorbid outpatients.
The objective is to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess whether a large scale cohort with FPs would be feasible.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 one other disease (acute or chronic) or a bio psychosocial factor (associated or not) or a somatic risk factor.
Exclusion Criteria:
- Exclusion criteria were patients not meeting the criteria of the definition of multimorbidity, the inability to follow the study over time (known to be leaving the practice in the following months), patients under legal protection, outpatients in palliative care for whom survival was estimated by the FPs at less than three months.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Multimorbidity cohort
The study population included a random sample of multimorbid patients (according to the EGPRN definition of multimorbidity).
Patients were selected by 19 FPs in their offices in the county of Finistere (in north-west France) from July 2014 to December 2014.
Randomization was achieved by including the first four multimorbid patients (according to the inclusion criteria) encountered during their second working day of each week.
As patients were booking their appointments with the practice without the FPs' clearance, the FPs were not able to select them
|
This questionnaire was to explore potential decompensation risk factors within themes and subthemes of multimorbidity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To detect the decompensating outpatients
Time Frame: 6 months
|
To assess which criteria in the EGPRN concept of multimorbidity could detect decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess whether a large scale cohort with FPs would be feasible
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SPURBO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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