Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Counter-referral System Improvement Collaborative (BIDCR-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775551
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
Ministry of Public Health, Argentina
Information provided by (Responsible Party):
Institute for Clinical Effectiveness and Health Policy

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).


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Quality Improvement Behavioral: Improvement cycle Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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.
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.
Other Name: quality improvement cycle




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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. 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

  4. 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

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775551


Contacts
Layout table for location contacts
Contact: Cintia Spira, MD +541147778767 ext 16 cspira@iecs.org.ar

Locations
Layout table for location information
Argentina
Hospital A Italo Perrupato Recruiting
San Martín, Mendoza, Argentina
Contact: Gladys Liliana Roggerone, MD         
Hospital Teodoro J. Schestakow Recruiting
San Rafael, Mendoza, Argentina
Contact: Ethel Larregle         
Hospital Antonio J. Scaravelli Recruiting
Tunuyán, Mendoza, Argentina
Contact: Carmelo Fazio         
Hospital N. Joaquín Castellano Recruiting
Güemes, Salta, Argentina
Contact: Estelina Aguirre         
Hospital Centro de Salud Zenón J. Santillán Recruiting
Tucumán, Tucuman, Argentina
Contact: Gustavo Paterlini         
Hospital Ángel C. Padilla Recruiting
Tucumán, Tucuman, Argentina
Contact: Paola Ingratta Giangreco         
Hospital Central Recruiting
Mendoza, Argentina
Contact: Raquel Saa, MD         
Hospital Luis Lagomaggiore Recruiting
Mendoza, Argentina
Contact: Jorge Piasentin         
Hospital Papa Francisco Recruiting
Salta, Argentina
Contact: Maria Eugenia Lanuza         
Hospital San Bernardo Recruiting
Salta, Argentina
Sponsors and Collaborators
Institute for Clinical Effectiveness and Health Policy
Ministry of Public Health, Argentina
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier: NCT03775551    
Other Study ID Numbers: C-RG-E1560-P002
20180328 ( Other Identifier: IECS )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute for Clinical Effectiveness and Health Policy:
quality improvement
collaborative
counter reference
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases