NCT02212171

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

2.1 years

First QC Date

August 6, 2014

Last Update Submit

August 4, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Baseline and at 24 months

  • New activities added to the current portfolio of services

    Baseline and at 24 months

  • Patient satisfaction

    Baseline and at 24 months

  • Satisfaction of health professionals

    Baseline and at 24 months

Study Arms (2)

TRIAP intervention

EXPERIMENTAL
Other: TRIAP

Usual care

NO INTERVENTION

Usual care: Patients in the control group will be treated according to Osakidetza recommendations.

Interventions

TRIAPOTHER

The 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.

TRIAP intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basque Healthcare Service

Vitoria-Gasteiz, Spain

Location

MeSH Terms

Interventions

Malononitrile dimer

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 8, 2014

Study Start

September 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations