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Completed

NCT Number: NCT01610674

Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored improvement strategy

Other

A step-wise implementation model is applied:

  • 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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. current care study

    Time frame: 1 year

    the secondary outcome measure is the outcome of care (e.g. glycemic control) before intervention data

  2. feasibility study

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
Jun 4, 2012
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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