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The evaluation of a Dutch cardiology Primary Car Plus intervention


- candidate number27730
- NTR NumberNTR6629
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-aug-2017
- Secondary IDs15-4-032 METC
- Public TitleThe evaluation of a Dutch cardiology Primary Car Plus intervention
- Scientific TitleThe evaluation of a cardiology Primary Care Plus centre on the Triple Aim outcomes (health, quality of care and healthcare costs) in comparison with care-as-usual (hospital-based outpatient care) including adult patients with non-aucte and low-complexity cardiology-related complaints.
- ACRONYM
- hypothesisThis overall study aims to evaluate the effects of cardiology PC+ centre on the Triple Aim outcomes. The underlying premises of the researchers on the effects of the intervention are that the cardiology PC+ centre will result in an (at least) equivalent health of the population, improved quality of care as experienced by patients and a reduced number of referrals to hospital-based outpatient cardiology care, and hence reduced health-care costs.
- Healt Condition(s) or Problem(s) studiedCardiology-related health issues
- Inclusion criteriaThe study population consists of adult patients (≥18 years) with non-acute and low-complexity cardiology-related health complaints, registered with a GP in the region of the pioneer site. Based on the principles of shared decision-making the GP and the patient will discuss the options for referral which will be either the PC+ centre (intervention group) or the hospital-based outpatient cardiology care (control group). The decision will be based on expertise and experience of the GP, the severity of the complaints of the patient and the preferences of the patient. Less sever, non-acute and low-complex patients should be referred to PC+. At the moment, no specific criteria are included for the referral to PC+. The GP is in charge of referring a patient to the PC+ centre or the hospital-based outpatient cardiology care, i.e. the researchers do not have any influence on the referrals.
- Exclusion criteriaExcluded from participation are patients who are already diagnosed with cardiology-related health problems by a cardiologist and patients who have received balloon angioplasty or bypass surgery in the past 18 months. Furthermore, patients with acute health problems who require immediate hospital care and/or patients arriving at the emergency department of the hospital are excluded from participation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate1-dec-2018
- Target number of participants858
- InterventionsIntervention: cardiology primary care plus centre
The PC+ intervention is a cardiology PC+ centre in which cardiologists, supported by other health-care professionals, provide specialist consultations in a primary care setting. Hospital diagnostic tools are available including an ultrasound device, an ergometer and an electrocardiogram (ECG). All GPs in the region participate in the PC+ intervention and are able to refer non-acute and low-complexity patients with cardiology-related complaints to the PC+ centre. Patients who are already diagnosed with cardiology-related health problems by a cardiologist are not appropriate for PC+ and (if needed) they will be treated by the cardiologist in the hospital-care setting. The consultation at the PC+ centre consists of the following diagnostic tests: a blood test, an ECG, an echo and an exercise test. The diagnostic tests are carried out by multiple health-care professionals, such as nurses, laboratory technicians and physicians, all specialized in cardiology. After the tests the patient meets the cardiologist, who explains the results of the diagnostic tests. The cardiologist sends a comprehensive description of the results of the tests, the diagnosis and his recommendation regarding further treatment (if needed) to the GP. The GP discusses the cardiologistís recommendation with the patient and based on the principles of shared decision-making the GP and the patient discuss the options for further treatment [24]. Moreover, the GP remains clinically in charge of the patient. The further treatment will depend on the results of the tests and the recommendation of the cardiologist; the three overall options are: 1) the patient needs no care (i.e. the patient has no health problems that need further attention), 2) the patient will remain in the primary care setting (the patient needs low-complexity care, e.g. medication) or, 3) the patient will be referred to secondary care (the patient needs specialist care).

Control: hospital-based outpatient cardiology care (care-as-usual)
Hospital-based outpatient cardiology care is considered care-as-usual. All GPs are allowed to refer non-acute and low-complexity patients with cardiology-related complaints to the hospital-based outpatient cardiology care. These patients receive the same care as within the PC+ centre, i.e. the same diagnostic tests carried out by health-care professionals with the same level of expertise. After the tests the patient meets the cardiologist, the cardiologist explains the results and they discuss further treatment (if needed). This underlines a significant difference with the intervention: in the PC+ centre the cardiologist provides only a recommendation on further treatment and the GP discusses the options for further treatment (instead of the cardiologist), i.e. within PC+ the GP remains in charge.
- Primary outcomeTriple Aim outcomes:
- Health of the population
- Quality of care
- Healthcare costs
- Secondary outcomeA qualitative study that will consist of semi-structured interviews, focus groups and observations. Besides evaluating the process of the introduction of PC+ (e.g. identifying the barriers and facilitators), the aim of the qualitative study is to clarify and explain quantitative results. Therefore, the qualitative study will be based on an adaptive approach; the ultimate design will depend on developments during the research and results of the quantitative study.
- TimepointsThe data will be collected at four different time points, namely at baseline, before the patient has the first consultation with the cardiologist (T0), a week after the first consultation (T1), three months after the first consultation (T2) and six months after the first consultation (T3).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Tessa Quanjel
- CONTACT for SCIENTIFIC QUERIES Tessa Quanjel
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University, Maastricht University Medical Center (MUMC+), Versterking Eerstelijn Zuid-Nederland (VEZN)
- Publications
- Brief summaryAbstract
Background. In an attempt to deal with the pressures on the health-care system and to guarantee sustainability, changes are needed. This study focuses on a cardiology primary care plus intervention. Primary care plus (PC+) is a new health-care delivery model focused on substitution of specialist care in the hospital setting with specialist care in the primary care setting. The intervention consists of a cardiology PC+ centre in which cardiologists, supported by other health-care professionals, provide consultations in a primary care setting. The PC+ centre aims to improve the health of the population and quality of care as experienced by patients, and reduce the number of referrals to hospital-based outpatient specialist care in order to reduce health-care costs. These aims reflect the Triple Aim principle. Hence, the objectives of the study are to evaluate the cardiology PC+ centre in terms of the Triple Aim outcomes and to evaluate the process of the introduction of PC+.
Methods/Design. The study is a practice-based, quantitative study with a longitudinal observational design, and an additional qualitative study to supplement, interpret and improve the quantitative study. The study population of the quantitative part will consist of adult patients (≥18 years) with non-acute and low-complexity cardiology-related health complaints, who will be referred to the cardiology PC+ centre (intervention group) or hospital-based outpatient cardiology care (control group). All eligible patients will be asked to complete questionnaires at three different time points consisting of questions about their demographics, health status and experience of care. Additionally, quantitative data will be collected about health-care utilization and related health-care costs at the PC+ centre and the hospital. The qualitative part, consisting of semi-structured interviews, focus groups, and observations, is designed to evaluate the process as well as to amplify, clarify and explain quantitative results.
Conclusions. This study will evaluate a cardiology PC+ centre using quantitative and supplementary qualitative methods. The findings of both sub-studies will fill a gap in knowledge about the effects of PC+ and in particular whether PC+ is able to pursue the Triple Aim outcomes.
Keywords. primary care, primary care plus, hospital care, Triple Aim, substitution, referral, cardiology
- Main changes (audit trail)
- RECORD9-aug-2017 - 25-aug-2017


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