NCT03775551

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

December 6, 2018

Last Update Submit

April 22, 2024

Conditions

Keywords

quality improvementcollaborativecounter reference

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Effective counter reference performed by physicians

    3 months after enrollment and/or end of study

  • Time to the first consultation in a PHC after the hospital discharge

    3 months after enrollment and/or .end of study

  • Cardiovascular hospital readmission's

    3 months after enrollment and/or end of study

  • Cardiovascular re consultations at the second level of care

    3 months after enrollment and/or end of study

  • Patients satisfaction with the primary health level measured by adapted PCAT questions

    4 months

Study Arms (2)

Control

NO INTERVENTION

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.

Improvement cycle

EXPERIMENTAL

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

Interventions

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
Improvement cycle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital A Italo Perrupato

San Martín, Mendoza Province, Argentina

Location

Hospital Teodoro J. Schestakow

San Rafael, Mendoza Province, Argentina

Location

Hospital Antonio J. Scaravelli

Tunuyán, Mendoza Province, Argentina

Location

Hospital N. Joaquín Castellano

General Güemes, Salta Province, Argentina

Location

Hospital Centro de Salud Zenón J. Santillán

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Hospital Ángel C. Padilla

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Hospital Central

Mendoza, Argentina

Location

Hospital Luis Lagomaggiore

Mendoza, Argentina

Location

Hospital Papa Francisco

Salta, Argentina

Location

Hospital San Bernardo

Salta, Argentina

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Vilma Irazola, MD

    Institute for Clinical Effectiveness and Health Policy

    PRINCIPAL INVESTIGATOR
  • Ezequiel García Elorrio, PhD

    Institute for Clinical Effectiveness and Health Policy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 14, 2018

Study Start

June 8, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations