Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care

NCT ID: NCT01610674

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 811 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Diabetes Mellitus; Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Tailored improvement strategy

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

Group Type: EXPERIMENTAL

Tailored improvement strategy

Intervention Type: OTHER

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.

Usual perioperative diabetes care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Marlies Hulscher

M.E.J.L. Hulscher, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marlies Hulscher, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 26384710 (View on PubMed)

Other Identifiers

Diabetesperiop2008

Identifier Type: -

Identifier Source: org_study_id