Counter-referral System Improvement Collaborative

Cardiovascular Diseases Clinical Trial

— BIDCR-R  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775551
• Other study ID #: C-RG-E1560-P002
• Secondary ID: 20180328
• Status: Completed
• Phase: N/A
• Start date: June 8, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2024
• Source: Institute for Clinical Effectiveness and Health Policy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Quality Improvement

Intervention

Behavioral:
• Improvement cycle
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.

Locations

Country	Name	City	State
Argentina	Hospital N. Joaquín Castellano	Güemes	Salta
Argentina	Hospital Central	Mendoza
Argentina	Hospital Luis Lagomaggiore	Mendoza
Argentina	Hospital Papa Francisco	Salta
Argentina	Hospital San Bernardo	Salta
Argentina	Hospital A Italo Perrupato	San Martín	Mendoza
Argentina	Hospital Teodoro J. Schestakow	San Rafael	Mendoza
Argentina	Hospital Ángel C. Padilla	Tucumán	Tucuman
Argentina	Hospital Centro de Salud Zenón J. Santillán	Tucumán	Tucuman
Argentina	Hospital Antonio J. Scaravelli	Tunuyán	Mendoza

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness and Health Policy	Ministry of Public Health, Argentina

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients visits in a primary health center (PHC) after hospital discharge	proportion of visits made in a primary care center (PHC) after hospital discharge	3 months after enrollment and/or end of study
Secondary	Effective counter reference performed by physicians	proportion of documented ( written) counter references by hospital physicians to a PHC	3 months after enrollment and/or end of study
Secondary	Time to the first consultation in a PHC after the hospital discharge	mean number of days upon patient hospital discharged to the first visit in a primary care center	3 months after enrollment and/or .end of study
Secondary	Cardiovascular hospital readmission's	proportion of re-admissions for the same primary admission condition for which the patient was discharged within the first 90 days	3 months after enrollment and/or end of study
Secondary	Cardiovascular re consultations at the second level of care	proportions of cardiovascular consultations at the secondary level of care after hospital discharge that should have been performed at the first level of care related to the condition for which the patient was included and admitted to the hospital	3 months after enrollment and/or end of study
Secondary	Patients satisfaction with the primary health level measured by adapted PCAT questions	patients satisfaction with the health care provided at the PHC measured by adapted PTCA questions. The Primary Care Assessment Tool was design to evaluate attainment of features in primary care settings. Attributes identified by the tool are first contact accessibility and use, continuity, and coordination in the primary level. The tool has been adapted and validated in several countries and settings. The global index for evaluation will be composed as the sum of 10 items, ranging from 10 to 40. To facilitate interpretation the score will be transformed to a scale of 0 -100 points ( score =100 x (sum -10)/40-10), with higher score indicating more favorable satisfaction.	4 months