- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03775551
Counter-referral System Improvement Collaborative (BIDCR-R)
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mendoza, Argentina
- Hospital Central
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Mendoza, Argentina
- Hospital Luis Lagomaggiore
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Salta, Argentina
- Hospital San Bernardo
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Salta, Argentina
- Hospital Papa Francisco
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Mendoza
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San Martín, Mendoza, Argentina
- Hospital A Italo Perrupato
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San Rafael, Mendoza, Argentina
- Hospital Teodoro J. Schestakow
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Tunuyán, Mendoza, Argentina
- Hospital Antonio J. Scaravelli
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Salta
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Güemes, Salta, Argentina
- Hospital N. Joaquín Castellano
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Tucuman
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Tucumán, Tucuman, Argentina
- Hospital Centro de Salud Zenón J. Santillán
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Tucumán, Tucuman, Argentina
- Hospital Ángel C. Padilla
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
The participants belonging to the hospitals assigned to the control group the health providers will give feedback on their health condition and will advise on how to follow up their care after discharge or referral back to PHC following usual practice.
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Experimental: Improvement cycle
In participants belonging to the hospitals assigned to the intervention group,the health providers will give feedback on their health condition and will advise on how to follow up their care after discharge or referral back to PHC using innovative intervention to assure continuity of care and assistant level approach.
This innovations will be crafted from the rapid improvement cycles considering the environment and key aspects of the every day care at the participating centers.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patients visits in a primary health center (PHC) after hospital discharge
Time Frame: 3 months after enrollment and/or end of study
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proportion of visits made in a primary care center (PHC) after hospital discharge
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3 months after enrollment and/or end of study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Effective counter reference performed by physicians
Time Frame: 3 months after enrollment and/or end of study
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proportion of documented ( written) counter references by hospital physicians to a PHC
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3 months after enrollment and/or end of study
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Time to the first consultation in a PHC after the hospital discharge
Time Frame: 3 months after enrollment and/or .end of study
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mean number of days upon patient hospital discharged to the first visit in a primary care center
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3 months after enrollment and/or .end of study
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Cardiovascular hospital readmission's
Time Frame: 3 months after enrollment and/or end of study
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proportion of re-admissions for the same primary admission condition for which the patient was discharged within the first 90 days
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3 months after enrollment and/or end of study
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Cardiovascular re consultations at the second level of care
Time Frame: 3 months after enrollment and/or end of study
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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
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3 months after enrollment and/or end of study
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Patients satisfaction with the primary health level measured by adapted PCAT questions
Time Frame: 4 months
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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.
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4 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vilma Irazola, MD, Institute for Clinical Effectiveness and Health Policy
- Principal Investigator: Ezequiel García Elorrio, PhD, Institute for Clinical Effectiveness and Health Policy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-RG-E1560-P002
- 20180328 (Other Identifier: IECS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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