An interventional study of Improvement cycle in Cardiovascular Diseases and Quality Improvement, sponsored by Institute for Clinical Effectiveness and Health Policy. Completed at 10 sites in Argentina. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Institute for Clinical Effectiveness and Health Policy · Not applicable, Interventional, and Health services research
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).
5,025 studies on the registry are indexed under Cardiovascular Diseases; 928 are open to participants now.
This study's enrollment of 510 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Institute for Clinical Effectiveness and Health Policy is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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.
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.
Also known as: quality improvement cycle
Patients visits in a primary health center (PHC) after hospital discharge
proportion of visits made in a primary care center (PHC) after hospital discharge
Time frame: 3 months after enrollment and/or end of study
Effective counter reference performed by physicians
proportion of documented ( written) counter references by hospital physicians to a PHC
Time frame: 3 months after enrollment and/or end of study
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
Time frame: 3 months after enrollment and/or .end of study
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
Time frame: 3 months after enrollment and/or end of study
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
Time frame: 3 months after enrollment and/or end of study
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.
Time frame: 4 months
Plan to share: Undecided
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Institute for Clinical Effectiveness and Health Policy