Social Determinants of HealthNCT04151056
Impact of the Social Determinants of Health in the Central Catalan Region
An observational study of Social Determinants of Health and Primary Health Care, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The objective of this study is to increase the registry of social determinants of health in the primary care centers and evaluate the relationship that these social determinants of health with various variables of social impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health, Primary Health Care
- How many people
- 1,500 participants
- Where
- 1 siteSpain
- Study dates
- 23 Sep 2019to 23 Jul 2021
- 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
- Adult, Older adult
Study population: Study population: Population assigned and attended at the 32 centers of primary care centers from the Catalan health institute of the Central Catalonia Sanitary Region.
Who may be able to join
- Phase I:
- Patients have been attended in their primary care centers during 23 September 2019 to 23 April 2020.
- The health professionals should complete the study checklist for each patient .
- Phase II:
- •Patients should sign the informed consent form to enter in a study cohort.
Who cannot join
- Patients with advanced cognitive impairment because they would not be able to complete the study checklist. The study checklist is consist in answering five questions.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Primary healthcare consultations of the Catalan health institute of the central catalonia region
Manresa, Barcelona, 08241
Jacobo Mendioroz Peña, MD, jmendioroz.cc.ics@gencat.cat
About this study
The objective of this study is to increase the registry of social determinants of health in the primary care centers and evaluate the relationship that these social determinants of health with various variables of social impact.
Read the detailed description
Currently, the social problems are hidden behind clinical diagnostics. This may lead to overdiagnosis and overtreatment of some discomforts/pathologies that are observed in primary care centers that may respond better to community level interventions and promotion of health actions.
It is longitudinal , multicentered, pre and post intervention study, conducted by health professionals of central Catalonia sanitary region during 2019 Prior to the intervention, the number and type of social coded diagnoses in the clinical history is going to be described. Subsequently, an intervention will be carried out: training the professionals in the homogeneous codification of five selected social determinants. This codification will be systematically applied .The number and type of social diagnostics registered in the pre and post-intervention periods is going to be compared. Finally, the impact analysis of the social determinants is going to be carried out.
Afterwards the investigators plan to search solutions at Community level for the select social diagnoses
- Conditions
- Social Determinants of Health, Primary Health Care
- Keywords
- social determinants of health, reporting socials problems
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 |
|---|---|---|
| Patients without social determinant of health | Patients without any of the five selected social determinants of health / Patients without any of the five selected social diagnosis. Patient with a registered diagnostic " Health check" (Z00.00) | |
| Patients with the social determinant"stressful work hours" | Patients with the selected social determinant of health. Patients with a registered diagnostic "stressful work hours " (Z56.3) | |
| Patients with the social determinant of health "living alone" | Patients with the select social determinant of health . Patients with the selected social determinant of health . Patients with a registered diagnostic " living alone problems" (Z60.2) | |
| Patients with the social determinant of health "acculturation" | Patients with the selected social determinant of health. Patients with a registered diagnostic "difficulty acculturation " (Z60.3) | |
| Patients with the social determinant "near surrounding" | Patients with the selected social determinant of health. Patients with a registered diagnostic "other specific problems related to the nearest surroundings" (Z63.8) | |
| Patients with the social determinant "unemployment" | Patients with the selected social determinant of health. Patients with a registered diagnostic "unemployment not specified" (Z56.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population Taxes
In the descriptive basal analysis, the population taxes of all social diagnoses is going to be described.
Measured: 12 month
Secondary outcomes (3)
Sociodemographic subcategories
The sociodemographic data described in the study are:
- age;
- sex;
- primary care team where the patient is visited;
- type of primary care team (rural/urban);
- index Aquas of deprivation ;
- professional situation;
- cultural origin of the person;
- if cultural origin is not Spanish, years of residence in the country.
Measured: 7 month
Comparison with the post-intervention data of the six diagnostics with Chi Quadrat Test.
For this comparison is going to be used independent samples in the different subcategories.
The 6 diagnostics used are:
- health check;
- stressful work hours;
- living alone problems ;
- difficult acculturation
- other specific problems related to the nearest surrounding;
- unemployment not specified.
Measured: 7 month
Social Impact. Parametric and non parametric test
It will be evaluated health differences in the six coded groups (including the control group) through appropriate parametric and non-parametric tests , It is going to be compared the average of each selected dependent health variables in social coded diagnoses and the screened patients group without a social diagnosis
The dependent health variables are going to be analysed after the codification of the six selected diagnosis. The study dependent health variables are:
- number of clinical diagnoses registered;
- number of medicines consumed ;
- number of the total diagnostic test requested;
- number of specialists referrals
- number of visits to health centers
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start23 Sep 2019
- Primary completion23 May 2021 (estimated)
- Study completion23 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor
- Investigators
- Jacobo Mendioroz peña, MD, Study chair, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151056
- Sponsor's protocol ID
- 19/079-P
- Status last verified
- Jul 2019
- First submitted
- 31 Oct 2019
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodoreda-Pallas B, Lumillo-Gutierrez I, Miro Catalina Q, Torra Escarrer E, Sanahuja Juncadella J, Morin Fraile V. Recording of Social Determinants in Computerized Medical Records in Primary Care Consultations: Quasi-Experimental Study. JMIR Form Res. 2023 Jan 25;7:e41706. doi: 10.2196/41706.
PubMed 36696168
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Social Determinants of Health in the Central Catalan Region
- ClinicalTrials.gov ID
- NCT04151056
- Acronym / sponsor ID
- 19/079-P
- Conditions
- Social Determinants of Health, Primary Health Care
- Keywords
- social determinants of health, reporting socials problems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 23 May 2021 (estimated)
- Study completion
- 23 Jul 2021 (estimated)
- First posted
- 5 Nov 2019 (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.
The objective of this study is to increase the registry of social determinants of health in the primary care centers and evaluate the relationship that these social determinants of health with various variables of social impact.
Detailed description
Currently, the social problems are hidden behind clinical diagnostics. This may lead to overdiagnosis and overtreatment of some discomforts/pathologies that are observed in primary care centers that may respond better to community level interventions and promotion of health actions.
It is longitudinal , multicentered, pre and post intervention study, conducted by health professionals of central Catalonia sanitary region during 2019 Prior to the intervention, the number and type of social coded diagnoses in the clinical history is going to be described. Subsequently, an intervention will be carried out: training the professionals in the homogeneous codification of five selected social determinants. This codification will be systematically applied .The number and type of social diagnostics registered in the pre and post-intervention periods is going to be compared. Finally, the impact analysis of the social determinants is going to be carried out.
Afterwards the investigators plan to search solutions at Community level for the select social diagnoses
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients without social determinant of health | – | –Patients without any of the five selected social determinants of health / Patients without any of the five selected social diagnosis. Patient with a registered diagnostic " Health check" (Z00.00) |
| Patients with the social determinant"stressful work hours" | – | –Patients with the selected social determinant of health. Patients with a registered diagnostic "stressful work hours " (Z56.3) |
| Patients with the social determinant of health "living alone" | – | –Patients with the select social determinant of health . Patients with the selected social determinant of health . Patients with a registered diagnostic " living alone problems" (Z60.2) |
| Patients with the social determinant of health "acculturation" | – | –Patients with the selected social determinant of health. Patients with a registered diagnostic "difficulty acculturation " (Z60.3) |
| Patients with the social determinant "near surrounding" | – | –Patients with the selected social determinant of health. Patients with a registered diagnostic "other specific problems related to the nearest surroundings" (Z63.8) |
| Patients with the social determinant "unemployment" | – | –Patients with the selected social determinant of health. Patients with a registered diagnostic "unemployment not specified" (Z56.0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population: Population assigned and attended at the 32 centers of primary care centers from the Catalan health institute of the Central Catalonia Sanitary Region.
Key inclusion criteria (5 listed)
- Patients have been attended in their primary care centers during 23 September 2019 to 23 April 2020.
- The health professionals should complete the study checklist for each patient .
- •Patients should sign the informed consent form to enter in a study cohort.
Key exclusion criteria (1 listed)
- Patients with advanced cognitive impairment because they would not be able to complete the study checklist. The study checklist is consist in answering five questions.
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
Population Taxes
Time frame: 12 month
In the descriptive basal analysis, the population taxes of all social diagnoses is going to be described.
3 secondary outcomes
Sociodemographic subcategories
Time frame: 7 month
Comparison with the post-intervention data of the six diagnostics with Chi Quadrat Test.
Time frame: 7 month
Social Impact. Parametric and non parametric test
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 36696168Rodoreda-Pallas B, Lumillo-Gutierrez I, Miro Catalina Q, Torra Escarrer E, Sanahuja Juncadella J, Morin Fraile V. Recording of Social Determinants in Computerized Medical Records in Primary Care Consultations: Quasi-Experimental Study. JMIR Form Res. 2023 Jan 25;7:e41706. doi: 10.2196/41706.
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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.
Jacobo Mendioroz peña, MD study chair
Institut Català de la Salut
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 Social Determinants of Health and Primary Health Care, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berta Rodoreda Pallàs, NR (618625138, brodoreda.lleida.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population Taxes (time frame: 12 month). 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 NCT04151056, which also lists 1 linked publication.
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 23 Jun 2020.