Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610674
• Other study ID #: Diabetesperiop2008
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: January 2016

Study information

• Verified date: August 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 811
• Est. completion date: January 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Surgery

Intervention

Other:
• Tailored improvement 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 3) based on this information an implementation strategy is developed; 4) implementation activities are enacted in 3 hospitals and 5) evaluated in a controlled before-after design in 6 hospitals providing before and after intervention 400 patients.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current care study	the primary outcome measure is the adherence to the quality indicators (derived from international guidelines and scientific literature); Baseline measurement	1 year
Primary	Feasibility study	the primary outcome measure regarding effectiveness is the adherence to developed quality indicators; baseline measurement and follow up measurement following improvement intervention	1 year
Primary	Barrier analysis	the primary outcomes in the barrier analysis are the barriers and facilitators among professionals regarding adherence to the quality indicators; interview study	1 year
Secondary	current care study	the secondary outcome measure is the outcome of care (e.g. glycemic control) before intervention data	1 year
Secondary	feasibility study	the secondary outcome measure is the outcome of care (e.g. glycemic control) before and after data; the secondary outcome measures are the experiences of professionals and patients with different elements of the implementation strategy and the changed care, and the cost of the tested strategy	1 year