Clinical trial NCT01610674: Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care
Official title: Perioperative Diabetes Care: Developing and Testing an Implementation Strategy in Terms of Effectiveness, Experiences and Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Surgery
Keywords: Diabetes mellitus
Surgery
Implementation
Quality of care
Quality indicators
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 811
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Optimising glycaemic control during hospital stay reduces the rate of infections, length of stay and mortality, in particular in surgical patients. In this study, we test a strategy to implement optimal perioperative diabetes care in a controlled before and after design in 6 Dutch hospitals.

Detailed description: OBJECTIVE/RESEARCH QUESTION Optimising glycaemic control during hospital stay reduces rate of infections, length of stay and mortality,in particular in surgical patients. In guidelines and literature recommendations on optimal perioperative diabetes care are described. Nevertheless, in daily practice, perioperative glycaemic control is very often not achieved. This study aims at developing an implementation strategy that is tested on feasibility to improve perioperative diabetes care in terms of effectiveness, experiences and costs.

DESIGN/OUTCOME MEASURES/IMPLEMENTATION STRATEGY A step-wise implementation model is applied: 1) recommendations on optimal perioperative diabetes care (e.g. the administration of intravenous insulin, encouragement of diabetes self-management) are systematically translated into quality indicators; 2a) using these quality indicators, current care is measured by performing a medical record search among 400 patients in 6 hospitals; 2b) barriers and facilitators for optimal care are measured by performing interviews with professionals and, e.g. regarding self-management, with patients; 3) based on this information an implementation strategy is developed;4) implementation activities are enacted and 5) evaluated in a controlled before-after design in 6 hospitals providing before and after intervention 400 patients.

DATA ANALYSIS To obtain an indication of the effectiveness of the strategy, baseline and post intervention outcomes of intervention hospitals are compared with outcomes in control hospitals, using the quality indicators. Experiences of participants in the intervention hospitals will be measured to, if necessary, adapt the strategy to make it more effective and acceptable.

ECONOMIC EVALUATION A cost analysis of the implementation strategy will take place. Implementation costs will be related to the difference in percentage of patients treated as described in the quality indicators before and after implementation. Information on the costs and effects at the patient level will also be compared before and after the implementation of the recommendations on optimal care.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus AND
* Cardiac surgery OR
* Abdominal surgery OR
* Large joint orthopedic surgery And
* Duration of surgery minimum one hour

Exclusion Criteria:

* Rejection to participation

Primary outcomes:
measure: Current care study
timeFrame: 1 year
measure: Feasibility study
timeFrame: 1 year
measure: Barrier analysis
timeFrame: 1 year
Secondary outcomes:
measure: current care study
timeFrame: 1 year
measure: feasibility study
timeFrame: 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Marlies Hulscher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hommel I, van Gurp PJ, Tack CJ, Wollersheim H, Hulscher ME. Perioperative diabetes care: development and validation of quality indicators throughout the entire hospital care pathway. BMJ Qual Saf. 2016 Jul;25(7):525-34. doi: 10.1136/bmjqs-2015-004112. Epub 2015 Sep 17.