|- candidate number||2448|
|- NTR Number||NTR892|
|- Date ISRCTN created||26-feb-2007|
|- date ISRCTN requested||21-feb-2007|
|- Date Registered NTR||7-feb-2007|
|- Secondary IDs||N/A |
|- Public Title||The Diabetes Guidelines Implementation in Hospitals Study. |
|- Scientific Title||Implementation of Guidelines on Diabetes Mellitus in Hospitals.|
|- hypothesis||A patient centred or a porfessional directed intervention to improve adherence to diabetes guidelines in hospitals are more (cost) effective compared to usual care.|
|- Healt Condition(s) or Problem(s) studied||Guidelines, Diabetes Mellitus, Guideline adherence , Physician-patient interaction, Empowerment|
|- Inclusion criteria||In 13 hospitals the first 150 patients with diabetes that came for a checkup at their internists were included.|
|- Exclusion criteria||1. Patients with a short (<1 year) life expectancy;|
2. Pregnant patients.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2000|
|- planned closingdate||18-mrt-2004|
|- Target number of participants||1950|
|- Interventions||At hospitals in the professional-directed group (n=4), the health professionals received aggregated feedback on baseline data on their patient population. During an educational meeting for internists, DSNs and dieticians, the guidelines were discussed, promoted and distributed by a national opinion leader in diabetic care. Also desktop reminder cards of key guidelines were distributed, including a nomogram to easily calculate the BMI. Internists and DSNs preferred these reminder cards to locally adapted written protocols. After six months the internists received personal benchmarked feedback on their clinical performance. |
At the hospitals in the patient centred group (n=4) intervention activities were addressed to the health care professionals and to the patients. As in the other intervention group feedback was given to the professionals on baseline data. During an educational meeting with a national opinion leader, guidelines as well as the diabetes passports were introduced. Barriers and facilitators to implement the diabetes passports in the clinic were discussed. Like in the other intervention group after six months personal feedback was given to the internists only, but this time on clinical performance as well as on the use of the diabetes passport. For the patients in the patient centred group, additional educational meetings were organised in collaboration with the local patient organisations. Furthermore 4,500 diabetes passports were made available at the four hospitals and waiting room posters, reminders for the patients to bring their passports and leaflets explaining how to use the passport were distributed. The passports were introduced and given to the patients by internists or DSNs during the clinic hours.
|- Primary outcome||The mean HbA1c level (mmol/l) of the patients in de different intervention groups.|
|- Secondary outcome||Clinical outcomes at the patient level: |
Quality of Life SF-20 locus of control and patient satisfaction
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Dijkstra|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Dijkstra|
|- Sponsor/Initiator ||University Medical Center St. Radboud, Center for Quality of Care Research (WOK)|
(Source(s) of Monetary or Material Support)
|Dutch Ministry of Health, Welfare and Sport|
|- Publications||Dijkstra RF, Niessen LW, Braspenning JC, Adang E, Grol RT. Patient-centred and professional-directed implementation strategies for diabetes guidelines: a cluster-randomized trial-based cost-effectiveness analysis. Diabet Med 2006;23(2):164-70. |
Dijkstra RF, Braspenning JC, Huijsmans Z, Akkermans RP, van Ballegooie E, ten Have P, et al. Introduction of diabetes passports involving both patients and professionals to improve hospital outpatient diabetes care. Diabetes Res Clin Pract 2005;68(2):126-34.
Diabet Med. 2004 Jun;21(6):586-91.
Dijkstra R, Braspenning J, Grol R. Empowering patients: how to implement a diabetes passport in hospital care. Patient Educ Couns 2002;47(2):173-7.
|- Brief summary||The clinical results of the study showed that, in both intervention groups, significant gains were found in HbA1c levels, but not in blood pressure levels. In the patient-centred group higher adherence rates were also found in examination of the feet and educational activities. Cost effectiveness analysis showed that cost effectiveness was found with the highest gains in the patient intervention group.|
|- Main changes (audit trail)|
|- RECORD||7-feb-2007 - 12-jun-2008|