Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Marlies Hulscher, Radboud University
ClinicalTrials.gov Identifier:
NCT01610674
First received: May 31, 2012
Last updated: June 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Surgery
Other: Intervention to improve perioperative diabetes care
Other: Usual perioperative diabetes care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Perioperative Diabetes Care: Developing and Testing an Implementation Strategy in Terms of Effectiveness, Experiences and Costs

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Current care study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

    Baseline measurement


  • Feasibility study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    the primary outcome measure regarding effectiveness is the adherence to developed quality indicators

    baseline measurement and follow up measurement following improvement intervention


  • Barrier analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

    interview study



Secondary Outcome Measures:
  • current care study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the secondary outcome measure is the outcome of care (e.g. glycemic control) before intervention data

  • feasibility study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 800
Study Start Date: January 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailored improvement strategy
In 3 hospitals a tailored strategy to improve perioperative diabetes care is performed
Other: Intervention to improve perioperative diabetes care

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.

No Intervention: Usual perioperative diabetes care
Three hospitals that provide usual perioperative diabetes care serve as control hospitals
Other: Usual perioperative diabetes care
Three hospitals that provide usual perioperative diabetes care serve as control hospitals.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610674

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Marlies Hulscher, PhD Radboud University
  More Information

No publications provided

Responsible Party: Marlies Hulscher, M.E.J.L. Hulscher, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01610674     History of Changes
Other Study ID Numbers: Diabetesperiop2008
Study First Received: May 31, 2012
Last Updated: June 1, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Diabetes mellitus
Surgery
Implementation
Quality of care
Quality indicators

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014