|- candidate number||27987|
|- NTR Number||NTR6733|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-okt-2017|
|- Secondary IDs||METC 14-4-136 METC aZM/UM|
|- Public Title||Evaluation of PC+ 2.0 in Blue Care according to Triple Aim|
|- Scientific Title||A prospective cohort study on the effectiveness and cost-effectiveness of Primary Care Plus (PC+)|
|- hypothesis||The aim/hypothesis is that PC+ results in lower health care costs compared with usual care, while maintaining or enhancing the health status and experience with care of the patients.|
|- Healt Condition(s) or Problem(s) studied||Primary Care Plus (PC+)|
|- Inclusion criteria||Included in the study are all adult patients (≥18 years) registered with a GP in the region Maastricht-Heuvelland who are referred during the intervention period via the TIPP system or via the GPs service desk with non-acute, non-
complex health problems to the medical specialities which provide primary care plus consultations (internal medicine, neurology, orthopaedics, dermatology, ophthalmology, rheumatology, gynecology, urology, ENT and in time possibly other medical specialties) and patients who give informed consent.
|- Exclusion criteria||Excluded from participation in this study are patients present in general practice with: 1)
acute health problems which require immediate referral to hospital care; 2) complex health
problems that require more sophisticated diagnostics or treatments not available in a PC+
setting; 3) complaints related to a prior diagnosis of diabetes mellitus, chronic obstructive
pulmonary disease and/or vascular risks, i.e. conditions for which bundled payment contracts
exist between regional health insurers and ZIO. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||1-dec-2020|
|- Target number of participants||3660|
|- Interventions||Primary Care Plus (PC+): This
intervention focuses on care substitution in which medical specialists perform consultations within a primary care setting. PC+ is assumed to slow down therising health care spending by reducing referrals to hospital_ care, minimizingdiagnostic procedures and follow-up visits in hospital care and by avoiding
unnecessary care loops. |
|- Primary outcome||The primary outcome of this study is the referral rate from PC+ to hospital care. |
|- Secondary outcome||Population health: Health status and health-related quality of life (HRQoL) will be measured with two generic, validated questionnaires: the EuroQol-5D (EQ-5D) and the 12-Item Short Form Health Survey (SF-12). |
Experience of care: Safety: Safety of care is measured using medical data made available by MUMC+ of patients from both study conditions
concerning (1) hospital admissions and (2) emergency care visits.
Medical data made available by insurance company VGZ is used to measure (3) mortality rates.
- Equity: Equity of care is examined by performing subgroup analysis on SES and age.
- Timeliness: Timeliness of care is examined by measuring the waiting time (in days) between the day that the patient makes an appointment through TIPP and the day of the 1st consultation with the medical specialist.
- Patient centered: Patient centered care is measured using items from the CQ Index Outpatient care and items derived from the CQ Index GP care.
- Efficiency: Efficiency of care is measured using TIPP data and medical data made available by the MUMC+ of patients from both experimental conditions concerning 1) average number of consultations within 6 months 2) average number of hospital admissions. In addition, for the PC+ condition the number and percentage of patients that is yet referred to hospital care after PC+ is measured.
- Effectiveness: Effectiveness of care is measured with the PAM-13 questionnaire measuring the level of patient engagement in their health care.
|- Timepoints||T0 (after contact with TIPP or with the GP and before the consultation with the medical specialist in PC+/ hospital) |
T1 (1 week after the first consultation with the medical specialist in PC+/hospital)
T2 (3 months after first consult with medical specialist in PC+/hospital)
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Veronique Frijns|
|- CONTACT for SCIENTIFIC QUERIES|| E.H.A. (Esther) van den Bogaart |
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+), Maastricht University, CZ Fonds, VGZ, Province of Limburg, Versterking Eerstelijn Zuid-Nederland (VEZN)|
|- Brief summary||In April 2013, the Dutch ministry of Health designated nine regions across the Netherlands which have been labelled as pioneer sites. One of those regions is Maastricht-Heuvelland located in the southern part of the Netherlands with pioneer site Blue Care'. The Blue Care pioneer site aims to achieve more sustainable care by initiating different interventions according to the Triple Aim principle of Berwick, Nolan and Whittington. They state that to achieve high quality improvements of care three aims should be linked; reduced care costs per capita should go along with improved population health and patient experiences.
One intervention in the Blue Care Pioneer site is Primary Care Plus (PC+). This intervention focuses on care substitution in which medical specialists perform
consultations within a primary care setting. PC+ is assumed to slow down the rising health care spending by reducing referrals to hospital care, minimizing diagnostic procedures and follow-up visits in hospital care and by avoiding unnecessary care loops. |
PC+ is an innovative, intensive primary-secondary care collaboration model that blurs the boundaries between primary (GP) and secondary (hospital) care.
PC+ knows various manifestations in health care. In the region Maastricht-Heuvelland PC+ medical specialists work in a neutral setting, consisting of two
health care centers located in Maastricht (outside the hospital MUMC+) to minimize unnecessary referrals to and subsequent use of hospital care. PC+
focuses on relatively uncomplicated, non-acute health problems which can be diagnosed and treated successfully in a primary care setting complemented by the necessary specialist knowledge. The GP decides whether a patient's complaint is suitable for referral to PC+. A referral by the GP is necessary to
gain access to PC+.
Medical specialists from several specialties (internal medicine, neurology, orthopedics, dermatology, ophthalmology, rheumatology, ENT, gynecology,
urology and in time possibly other specialties) give consultations in two PC+ health care centers located in the western and eastern part of Maastricht.
Patients with non-complex, non-acute symptoms, who are normally referred to hospital care, are eligible for PC+. The consultation in PC+ consists of a
shortened medical specialist's consultation, with minimal diagnostic tools (comparable with a primary care setting) available. Medical specialists examine
patients, independently from the GP. After the consultation, the medical specialist gives feedback to the referring GP. In the feedback message, the
medical specialist gives advice to the GP for further treatment by the GP in the primary care setting, or advices referral to secondary hospital care for further
diagnosis and/or treatment. The medical specialist deliberates with the GP, but GPs stay in charge.
To evaluate PC+, referrals to a medical specialist in the hospital (MUMC+) are used as a control group. The care provided by the medical specialist may
consist of one or more consultations, diagnostics, and treatment.
|- Main changes (audit trail)|
|- RECORD||5-okt-2017 - 28-okt-2017|