Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care
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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 |
- 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
- 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 |
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 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 May 22, 2013