Organization of Health ServicePhase 2TRIAPNCT02212171
TRIAP: Is Triage by Healthcare Mini-teams Effective to Improve Efficiency in Primary Health Care?
A Phase 2 study testing TRIAP in people with Organization of Health Service, run by Basque Health Service at 1 site in Spain.
Trial summary
Background: With new challenges for healthcare, there is a clear consensus among experts on the need to introduce changes in the organization of care in health centres to address the problems of over-attendance, bureaucratization and other emerging issues that require growing amounts of attention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Organization of Health Service
- What is being tested?
- TRIAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Oct 2014
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The study populations are patients of the seven mini-teams established, these professionals being responsible for the GP lists in the health centres of San Miguel in Basauri, Miraballes and Ondarroa, and the paediatric list in Etxebarri health centre. The control units are from the health centres of Basauri-Ariz, Arratia, Amorebieta and Bermeo, all located in the Interior Health Region.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Background: With new challenges for healthcare, there is a clear consensus among experts on the need to introduce changes in the organization of care in health centres to address the problems of over-attendance, bureaucratization and other emerging issues that require growing amounts of attention. However, there has been insufficient research into possible models and the impact of their adoption.
The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new organizational model based on triage and healthcare mini-teams (two general practitioners/pediatricians, two nurses and one member of the administrative staff) compared to the current model, aiming to achieve a correct classification of the healthcare needs of the primary care population and direct them to the most suitable professional.
Read more
In addition, the implementation research objective is to identify the facilitators for and barriers to the implementation of the intervention in the context of primary care.
Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14 healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the Basque Healthcare Service (Osakidetza) Interior Health Region.
The results will be assessed using the data on morbidity-adjusted attendance of users to their family doctor, number of referral, addition of new activities to the portfolio of services, and patient perception and professional satisfaction. All the variables will be measured at baseline and at the end of the intervention, 24 months later.
Using covariance analysis models, the investigators will estimate the effect attributable to the intervention by analyzing differences in changes between the two groups, and calculating the 95% confidence interval, adjusting the comparisons for baseline values. The investigators will also adjust for potential confounding and effect-modifying variables.
Nominal groups will be held at the end of the intervention with the participation of all the agents involved in intervention centres to identify the facilitators for and barriers to the implementation of the intervention.
Discussion: There is a need to develop new forms of organization in primary care services to respond to new healthcare demands. To pursue this aim, changes have to be introduced in the organization of healthcare within health centres, redefining the roles of primary care professionals and refocusing their activity towards population health needs, seeking greater efficiency in health services.
- Conditions
- Organization of Health Service
- Being tested
- TRIAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIAPOther
The primary healthcare professionals organised in healthcare mini-teams, composed of 2 doctors, 2 nurses and 1 member of the administrative staff.
- Administrative staff: Following a flow chart, they will refer patients with mild self-limiting illnesses as well as consultations regarding chronic disorders in adults to the nurses. They will also perform administrative tasks such as the printing of prescriptions, sick leave reports and medical notes (justifying absence), etc.
- Nursing staff: They will carry out activities focused on health promotion, self-management and de-medicalisation during visits from patients with mild self-limiting illnesses as well as appointments for chronic diseases in adults.
- GP:
They will develop the new portfolio of services: health promotion, joint review of patient medical records by doctors and nurses to improve the management of certain groups of patients, and organization of minor surgery services, etc.
| Study group | Role | What they receive |
|---|---|---|
| TRIAP intervention | Experimental | Not described Receives: Other: TRIAP |
| Usual care | No intervention | Usual care: Patients in the control group will be treated according to Osakidetza recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients attendance
Number of visits of the patients to their GP and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.
The patients will be classified using the ACG system, on the basis of their age, sex and ICD-9-CM codes of health problems diagnosed over a year in visits to their GP/paediatrician. The ACG case-mix system was designed by researchers at Johns Hopkins University, originally for care on an outpatient basis, and classifies the population into around 100 self-excluding categories.
Regardless of the number of contacts with the healthcare services, each person is classified every year into a single ACG depending on their age, sex, and combination of diagnoses they were assigned over the previous 12 months. For this study, we will use the ACG Assignment Software version 7.00.
All the tasks performed will be recorded in the Osabide computer system of the Basque Health Service.
Measured: Baseline and at 24 months
Secondary outcomes (4)
Patients referral: number of patient referrals by GPs and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.
Measured: Baseline and at 24 months
New activities added to the current portfolio of services
Number of programmed activities of health promotion, joint review of medical records by the doctors and nurses to improve the management of certain groups of patients, minor surgery services in PC, activities for achieving a comprehensive approach to managing non-surgical osteomuscular disorders and the use of ultrasound scans.
Measured: Baseline and at 24 months
Patient satisfaction
Measured using the Primary Care Assessment Tool (PCAT) Pasarín MI et al. Evaluation of primary care: The "Primary Care Assessment Tools - Facility version" for the Spanish health system. Gac Sanit. 2013 Jan-Feb;27(1):12-8.
Measured: Baseline and at 24 months
Satisfaction of health professionals
In terms of professional quality of life measured using the Professional Quality of Life questionnaire (PQL-35).
Cabezas, C. La calidad de vida de los profesionales. FMC. 2000;7 (Supl 7):53-68.
Measured: Baseline and at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organization of Health ServiceStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roberto Gonzalez Santisteban, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212171
- Sponsor's protocol ID
- TRIAP
- Other IDs
- 2011111131
- Acronym
- TRIAP
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2014
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIAP: Is Triage by Healthcare Mini-teams Effective to Improve Efficiency in Primary Health Care?
- ClinicalTrials.gov ID
- NCT02212171
- Acronym / sponsor ID
- TRIAP / TRIAP
- Conditions
- Organization of Health Service
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Aug 2014 (estimated)
- 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: With new challenges for healthcare, there is a clear consensus among experts on the need to introduce changes in the organization of care in health centres to address the problems of over-attendance, bureaucratization and other emerging issues that require growing amounts of attention. However, there has been insufficient research into possible models and the impact of their adoption.
The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new organizational model based on triage and healthcare mini-teams (two general practitioners/pediatricians, two nurses and one member of the administrative staff) compared to the current model, aiming to achieve a correct classification of the healthcare needs of the primary care population and direct them to the most suitable professional.
In addition, the implementation research objective is to identify the facilitators for and barriers to the implementation of the intervention in the context of primary care.
Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14 healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the Basque Healthcare Service (Osakidetza) Interior Health Region.
The results will be assessed using the data on morbidity-adjusted attendance of users to their family doctor, number of referral, addition of new activities to the portfolio of services, and patient perception and professional satisfaction. All the variables will be measured at baseline and at the end of the intervention, 24 months later.
Using covariance analysis models, the investigators will estimate the effect attributable to the intervention by analyzing differences in changes between the two groups, and calculating the 95% confidence interval, adjusting the comparisons for baseline values. The investigators will also adjust for potential confounding and effect-modifying variables.
Nominal groups will be held at the end of the intervention with the participation of all the agents involved in intervention centres to identify the facilitators for and barriers to the implementation of the intervention.
Discussion: There is a need to develop new forms of organization in primary care services to respond to new healthcare demands. To pursue this aim, changes have to be introduced in the organization of healthcare within health centres, redefining the roles of primary care professionals and refocusing their activity towards population health needs, seeking greater efficiency in health services.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRIAP intervention | Experimental | Other: TRIAP |
| Usual care | No intervention | –Usual care: Patients in the control group will be treated according to Osakidetza recommendations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The study populations are patients of the seven mini-teams established, these professionals being responsible for the GP lists in the health centres of San Miguel in Basauri, Miraballes and Ondarroa, and the paediatric list in Etxebarri health centre. The control units are from the health centres of Basauri-Ariz, Arratia, Amorebieta and Bermeo, all located in the Interior Health Region.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| TRIAPThe primary healthcare professionals organised in healthcare mini-teams, composed of 2 doctors, 2 nurses and 1 member of the administrative staff. 1. Administrative staff: Following a flow chart, they will refer patients with mild self-limiting illnesses as well as consultations regarding chronic disorders in adults to the nurses. They will also perform administrative tasks such as the printing of prescriptions, sick leave reports and medical notes (justifying absence), etc. 2. Nursing staff: They will carry out activities focused on health promotion, self-management and de-medicalisation during visits from patients with mild self-limiting illnesses as well as appointments for chronic diseases in adults. 3. GP: They will develop the new portfolio of services: health promotion, joint review of patient medical records by doctors and nurses to improve the management of certain groups of patients, and organization of minor surgery services, etc. | Other | TRIAP intervention |
Primary outcome
Patients attendance
Time frame: Baseline and at 24 months
Number of visits of the patients to their GP and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System. The patients will be classified using the ACG system, on the basis of their age, sex and ICD-9-CM codes of health problems diagnosed over a year in visits to their GP/paediatrician. The ACG case-mix system was designed by researchers at Johns Hopkins University, originally for care on an outpatient basis, and classifies the population into around 100 self-excluding categories. Regardless of the number of contacts with the healthcare services, each person is classified every year into a single ACG depending on their age, sex, and combination of diagnoses they were assigned over the previous 12 months. For this study, we will use the ACG Assignment Software version 7.00. All the tasks performed will be recorded in the Osabide computer system of the Basque Health Service.
4 secondary outcomes
Patients referral: number of patient referrals by GPs and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.
Time frame: Baseline and at 24 months
New activities added to the current portfolio of services
Time frame: Baseline and at 24 months
Patient satisfaction
Time frame: Baseline and at 24 months
Satisfaction of health professionals
Time frame: Baseline and at 24 months
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 6 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRIAP in people with Organization of Health Service, run by Basque Health Service 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 1 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: finished, as of the sponsor's last update on 6 Aug 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patients attendance (time frame: Baseline and at 24 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 6 Aug 2015.