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Clinical Trials/NCT01610674
NCT01610674CompletedNot Applicable

Perioperative Diabetes Care: Developing and Testing an Implementation Strategy in Terms of Effectiveness, Experiences and Costs

Radboud University Medical Center2 sites in 1 country811 target enrollmentStarted: January 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
811
Locations
2
Primary Endpoint
Feasibility study

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Tailored improvement strategy

Experimental

In 3 hospitals a tailored strategy to improve perioperative diabetes care is performed

Intervention: Tailored improvement strategy (Other)

Usual perioperative diabetes care

No Intervention

Three hospitals that provide usual perioperative diabetes care serve as control hospitals

Outcomes

Primary Outcomes

Feasibility study

Time Frame: 1 year

the primary outcome measure regarding effectiveness is the adherence to developed quality indicators baseline measurement and follow up measurement following improvement intervention

Current care study

Time Frame: 1 year

the primary outcome measure is the adherence to the quality indicators (derived from international guidelines and scientific literature) Baseline measurement

Barrier analysis

Time Frame: 1 year

the primary outcomes in the barrier analysis are the barriers and facilitators among professionals regarding adherence to the quality indicators interview study

Secondary Outcomes

  • feasibility study(1 year)
  • current care study(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marlies Hulscher

M.E.J.L. Hulscher, PhD

Radboud University Medical Center

Study Sites (2)

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