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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.
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:
  • quality improvement cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients visits in a primary health center (PHC) after hospital discharge
Time Frame: 3 months after enrollment and/or end of study
proportion of visits made in a primary care center (PHC) after hospital discharge
3 months after enrollment and/or end of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective counter reference performed by physicians
Time Frame: 3 months after enrollment and/or end of study
proportion of documented ( written) counter references by hospital physicians to a PHC
3 months after enrollment and/or end of study
Time to the first consultation in a PHC after the hospital discharge
Time Frame: 3 months after enrollment and/or .end of study
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
Cardiovascular hospital readmission's
Time Frame: 3 months after enrollment and/or end of study
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
Cardiovascular re consultations at the second level of care
Time Frame: 3 months after enrollment and/or end of study
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
Patients satisfaction with the primary health level measured by adapted PCAT questions
Time Frame: 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Improvement cycle

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