NCT01610674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
811

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

5.5 years

First QC Date

May 31, 2012

Last Update Submit

August 26, 2019

Conditions

Diabetes MellitusSurgery

Keywords

Diabetes mellitusSurgeryImplementationQuality of careQuality indicators

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • current care study

    1 year

  • feasibility study

    1 year

Study Arms (2)

Tailored improvement strategy

EXPERIMENTAL

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

Other: Tailored improvement strategy

Usual perioperative diabetes care

NO INTERVENTION

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

Interventions

Tailored improvement strategyOTHER

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.

Tailored improvement strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus AND
  • Cardiac surgery OR
  • Abdominal surgery OR
  • Large joint orthopedic surgery And
  • Duration of surgery minimum one hour

You may not qualify if:

  • Rejection to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26384710DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Marlies Hulscher, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.E.J.L. Hulscher, PhD

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

January 1, 2009

Primary Completion

July 1, 2014

Study Completion

January 1, 2016

Last Updated

August 29, 2019

Record last verified: 2019-08

Locations

NL(1)