|- candidate number||3561|
|- NTR Number||NTR1369|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jul-2008|
|- Secondary IDs||ML 2719 |
|- Public Title||Diabetes Project Leuven, Belgium.|
|- Scientific Title||A clustered randomized trial in diabetes care to improve adherence to guidelines and to reduce the rate of clinical inertia in primary care physicians|
|- ACRONYM||DPL (Diabetes Project Leuven)|
|- hypothesis||A first hypothesis is that an advanced quality improvement program (AQIP) significantly improves clinical outcomes in persons with type 2 diabetes compared to a usual quality improvement program (UQIP). |
The second hypothesis is that persons with type 2 diabetes who make use of a Diabetes Care Team (DCT) have significant better patient related outcomes compared to non-users of the DCT.
A third hypothesis is that primary care physicians who participate in the AQIP implementation program have better process outcomes compared to physicians who participate in the UQIP.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Diabetes Mellitus, Primary care, Adherence to guidelines|
|- Inclusion criteria||All 379 primary care physicians (PCP’s) that actively execute their profession in the project region were invited to participate. |
These PCP’s work in a semi-rural setting with 357.000 inhabitants in Belgium and predominantly serve Caucasian patients with diabetes mellitus type 2.
Primary care physicians provide care for approximately 80% of patients with type 2 diabetes, and are often the sole providers of care.
The only inclusion criterion for the providers is the agreement to bring in all their known patients with type 2 diabetes mellitus. In this way selection bias is prevented. In addition, PCP’s will be asked to screen more systematically for new type 2 diabetes mellitus patients during 7 months after the start of the registration period.
Diabetes is defined in accordance to the 2003 ADA criteria with PCP’s to take the final decision about the diagnosis of type 2 diabetes.
|- Exclusion criteria||Type 1 diabetes mellitus patients. Patients not capable to provide informed consent.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2005|
|- planned closingdate||31-dec-2008|
|- Target number of participants||120|
|- Interventions||Type of interventions: |
Two separate groups are randomly defined. The first group receives an advanced quality improvement program (AQIP-program) whereas a second group receives a usual quality improvement program (UQIP-program). Physicians can make use of the services of the programs on a voluntary basis.
In a first intervention arm a set of ‘usual’ quality improvement interventions (UQIP) will be implemented with the aim to improve adherence to evidence-based guidelines and to reduce the rate of clinical inertia in primary care physicians (PCP’s). The term ‘usual’ is applied since these interventions address the principal factors contributing to clinical inertia (physician, patient and office system factors) and represent standard requirements for what is considered quality of diabetes care in most health care systems according to international clinical guidelines and theoretical frameworks on quality of diabetes care in particular.
In addition to interventions as defined in the UQIP, PCP’s and their patients of the second intervention arm will receive supplementary and more experimental interventions that we refer to as ‘advanced’ quality improvement interventions. The interventions of this Advanced Quality Improvement Program (AQIP) aim at improvements in adherence to evidence-based guidelines and a reduction of the rate of clinical inertia in PCP’s by means of an extended focus on behavior changes in patients and providers. Interventions that focus on the patient aim at a more active involvement of the patient in his/her treatment regimen with a special focus on lifestyle attitude changes. Interventions that target the provider (PCP’s) focus on improvements in communication patterns with patients, interdisciplinary shared care and the involvement of PCP’s in community campaigns.
|- Primary outcome||The primary endpoints of the study are the proportion of patients reaching the ADA-targets for three bio-clinical outcomes: |
1. HbA1c < 7%
2. SBD 130 mm Hg
3. LDL-C < 100mg/dl.
|- Secondary outcome||Secondary endpoints are individual improvements of 12 validated parameters, i.e. |
- Total Cholesterol
- Diastolic Blood Pressure (DBP)
- Physical exercise
- Healthy diet
- Smoking status
- Anti-platelet therapy.
|- Timepoints||T0 (January 2005-June 2005) |
T1 (end of project)
|- Trial web site||http://www.diabetesproject.be|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Liesbeth Borgermans|
|- CONTACT for SCIENTIFIC QUERIES|| Liesbeth Borgermans|
|- Sponsor/Initiator ||National Institute for Health and Disability Insurance, Belgium|
(Source(s) of Monetary or Material Support)
|National Institute for Health and Disability Insurance, Belgium|
|- Brief summary||ABSTRACT |
To evaluate the effectiveness of a two- arm quality improvement programme in diabetes care on improvements in adherence to evidence-based guidelines and a reduction in the rate of clinical inertia in primary care physicians.
Clustered randomized trial with 18-month intervention period. The “UQIP” group (53 GPs, 918 patients) was subjected to basic re-structuring of care. The “AQIP" Programme” group (67 GPs 1577 patients) in addition received more cost-intensive interventions both at the GP’s (patient centred feedback, peer review, education on motivational interviewing) and the patient’s level (group education by nurse educators at home and interventions of a health psychologist).
Primary therapeutic targets were:
HbA1c < 7%; LDL-Cholesterol < 100 mg/dl ; Systolic Blood Pressure 130 mm Hg. Secondary endpoints included other validated targets. Statistical analyses were performed in an intention to treat approach, using a multilevel model.
The proportion of patients on target before and after intervention significantly increased in the UQIP and the AQIP groups respectively from 53 to 66% and 55 to 68% (HbA1c), from 41 to 55% and 42 to 60% (LDL-C), from 48 to 53% and 50 tot 60% (SBP). Evolutions over time in these three targets were significant (p<0.0001) but not different in the two groups. UQIP and AQIP differed only in two secondary endpoints, i.e. a higher increase in the latter of the proportion of patients receiving anti-platelet therapy and in those doing physical exercise. Higher initial values were associated with better improvement.
The restructuring of a healthcare setting that is not well adapted to chronic care delivery results into significant positive outcomes and thus better quality of care. Cost-intensive interventions show little additional benefit.
|- Main changes (audit trail)|
|- RECORD||7-jul-2008 - 25-jul-2008|