Cardiovascular DiseasesBIDCR-RNCT03775551
Counter-referral System Improvement Collaborative
A study testing Improvement cycle in people with Cardiovascular Diseases and Quality Improvement, run by Institute for Clinical Effectiveness and Health Policy at 10 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Quality Improvement
- What is being tested?
- Improvement cycle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 10 sitesArgentina
- Study dates
- 8 Jun 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Argentina10 sites
Hospital N. Joaquín Castellano
General Guemes, Salta Province
Hospital Central
Mendoza
Hospital Luis Lagomaggiore
Mendoza
Hospital Papa Francisco
Salta
Hospital San Bernardo
Salta
Hospital A Italo Perrupato
San Martin, Mendoza Province
Hospital Centro de Salud Zenón J. Santillán
San Miguel de Tucumán, Tucumán Province
Hospital Ángel C. Padilla
San Miguel de Tucumán, Tucumán Province
Hospital Teodoro J. Schestakow
San Rafael, Mendoza Province
Hospital Antonio J. Scaravelli
Tunuyan, Mendoza Province
About this study
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
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.
Read more
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).
- Conditions
- Cardiovascular Diseases, Quality Improvement
- Being tested
- Improvement cycle
- Keywords
- quality improvement, collaborative, counter reference
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvement cycleBehavioural
Also called quality 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Improvement cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients visits in a primary health center (PHC) after hospital discharge
proportion of visits made in a primary care center (PHC) after hospital discharge
Measured: 3 months after enrollment and/or end of study
Secondary outcomes (5)
Effective counter reference performed by physicians
proportion of documented ( written) counter references by hospital physicians to a PHC
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start8 Jun 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Public Health, Argentina
- Responsible party
- Sponsor
- Investigators
- Vilma Irazola, MD, Principal investigator, Institute for Clinical Effectiveness and Health PolicyEzequiel García Elorrio, PhD, Principal investigator, Institute for Clinical Effectiveness and Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775551
- Sponsor's protocol ID
- C-RG-E1560-P002
- Other IDs
- 20180328
- Acronym
- BIDCR-R
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2018
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03775551
- Acronym / sponsor ID
- BIDCR-R / C-RG-E1560-P002
- Conditions
- Cardiovascular Diseases, Quality Improvement
- Keywords
- quality improvement, collaborative, counter reference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness and Health PolicyUniversity, hospital or other
- Collaborators
- Ministry of Public Health, Argentina
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Improvement cycleIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improvement cycleAlso: quality improvement cycleat 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. | Behavioural | Improvement cycle |
Primary outcome
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
5 secondary outcomes
Effective counter reference performed by physicians
Time frame: 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
Cardiovascular hospital readmission's
Time frame: 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
Patients satisfaction with the primary health level measured by adapted PCAT questions
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilma Irazola, MD principal investigator
Institute for Clinical Effectiveness and Health Policy
Ezequiel García Elorrio, PhD principal investigator
Institute for Clinical Effectiveness and Health Policy
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improvement cycle in people with Cardiovascular Diseases and Quality Improvement, run by Institute for Clinical Effectiveness and Health Policy at 10 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients visits in a primary health center (PHC) after hospital discharge (time frame: 3 months after enrollment and/or end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.