Clinical trial NCT03775551: Counter-referral System Improvement Collaborative
Official title: Evaluation of the Effectiveness of an Improvement Collaborative Strategy to Improve the Counter-referral System of Patients With Cardiovascular Disease in the Public Healthcare Sector in Argentina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Quality Improvement
Keywords: quality improvement
collaborative
counter reference
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: Ministry of Public Health, Argentina
First posted: 2018-12-14
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Coordination between different levels of care has been identified as one of the main components of care among people with chronic diseases. In this sense, an adequate referral and counter-reference system facilitates the management of the care process with timely access to the required referral. The objective of this project is to evaluate the effectiveness of a multicomponent strategy that improves the counter- referral process in patients with cardiovascular diseases in the public health system.

Population: The study will be carried out in selected hospitals of the provinces of Mendoza, Tucumán and Salta in Argentina. Patients who have been hospitalized with a diagnosis of heart failure, hypertension (requires hospitalization) and / or coronary disease (unstable angina) will be included.

Design and methods: a Randomized clinical study by clusters. 10 hospital will be included: 5 will be randomly assigned to receive an intervention to increase the improve counter referral rates (improvement cycles) and 5 to the control branch (usual care). 51 participants will be included in each hospital, in total, 510 participants.

Intervention: An innovative vision is proposed, which combines a participatory and dynamic methodology based on improvement cycles. This approach includes the implementation of participatory learning sessions for health providers, involving the effectors of the design of the intervention. In the intervention branch at least 6 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices. Each one of the sessions will constitute an analysis of the improvement cycle, following the following steps: 1) Selection of participants of the initial workshop; 2) Development of work model based on bibliographic review and initial qualitative phase; 3) Initial workshop with effectors for training in continuous improvement, objectives, interventions and data collection; 4) Learning workshops to discuss results, applicability of interventions and modifications to the work plan; 5) Closing session to evaluate preliminary results and discuss continuity of interventions beyond the project.

Outcomes: 1) consultation in the PHC after hospital discharge; 2) readmission's; 3) consultations in the hospital; 4) follow-up in the PHC; 5) patient perspective (satisfaction).


Eligibility criteria: Inclusion Criteria:

* Subjects that only have public health coverage or PAMI
* Adults over 18 year of age
* Patients admitted to the hospital with diagnosis of: non valvular heart failure and/or complicated hypertension ( that requires hospitalization) and/or coronary heart disease ( unstable angina)
* Residence in the area of influence of the hospitals

Exclusion Criteria:

* Pregnant women
* Anticoagulated patients
* People who are immobilized
* People who do not give their informed consent
* People who plan to move in the next 3 months

Primary outcomes:
measure: Patients visits in a primary health center (PHC) after hospital discharge
timeFrame: 3 months after enrollment and/or end of study
Secondary outcomes:
measure: Effective counter reference performed by physicians
timeFrame: 3 months after enrollment and/or end of study
measure: Time to the first consultation in a PHC after the hospital discharge
timeFrame: 3 months after enrollment and/or .end of study
measure: Cardiovascular hospital readmission's
timeFrame: 3 months after enrollment and/or end of study
measure: Cardiovascular re consultations at the second level of care
timeFrame: 3 months after enrollment and/or end of study
measure: Patients satisfaction with the primary health level measured by adapted PCAT questions
timeFrame: 4 months
Other outcomes:
Locations:
city: San Martín
country: Argentina
facility: Hospital A Italo Perrupato
state: Mendoza
city: San Rafael
country: Argentina
facility: Hospital Teodoro J. Schestakow
state: Mendoza
city: Tunuyán
country: Argentina
facility: Hospital Antonio J. Scaravelli
state: Mendoza
city: Güemes
country: Argentina
facility: Hospital N. Joaquín Castellano
state: Salta
city: Tucumán
country: Argentina
facility: Hospital Centro de Salud Zenón J. Santillán
state: Tucuman
city: Tucumán
country: Argentina
facility: Hospital Ángel C. Padilla
state: Tucuman
city: Mendoza
country: Argentina
facility: Hospital Central
city: Mendoza
country: Argentina
facility: Hospital Luis Lagomaggiore
city: Salta
country: Argentina
facility: Hospital Papa Francisco
city: Salta
country: Argentina
facility: Hospital San Bernardo
Study officials:
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Vilma Irazola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Ezequiel García Elorrio, PhD
role: PRINCIPAL_INVESTIGATOR
References: