Diabetes MellitusNCT01610674
Developing and Testing an Implementation Strategy to Improve Perioperative Diabetes Care
A study testing Tailored improvement strategy in people with Diabetes Mellitus and Surgery, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Surgery
- What is being tested?
- Tailored improvement strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 811 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus AND
- Cardiac surgery OR
- Abdominal surgery OR
- Large joint orthopedic surgery And
- Duration of surgery minimum one hour
Who cannot join
- Rejection to participation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: Perioperative Diabetes Care: Developing and Testing an Implementation Strategy in Terms of Effectiveness, Experiences and Costs
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.
Read the 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
- Being tested
- Tailored improvement strategy
- Keywords
- Diabetes mellitus, Surgery, Implementation, Quality of care, Quality indicators
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored improvement strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored improvement strategy | Experimental | In 3 hospitals a tailored strategy to improve perioperative diabetes care is performed Receives: Other: Tailored improvement strategy |
| Usual perioperative diabetes care | No intervention | Three hospitals that provide usual perioperative diabetes care serve as control hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current care study
the primary outcome measure is the adherence to the quality indicators (derived from international guidelines and scientific literature)
Baseline measurement
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (2)
current care study
the secondary outcome measure is the outcome of care (e.g. glycemic control) before intervention data
Measured: 1 year
feasibility study
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJan 2009
- Primary completionJul 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlies Hulscher, Radboud University Medical Center
- Investigators
- Marlies Hulscher, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610674
- Sponsor's protocol ID
- Diabetesperiop2008
- Status last verified
- Aug 2019
- First submitted
- 31 May 2012
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26384710
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Diabetes Care: Developing and Testing an Implementation Strategy in Terms of Effectiveness, Experiences and Costs
- ClinicalTrials.gov ID
- NCT01610674
- Acronym / sponsor ID
- Diabetesperiop2008
- Conditions
- Diabetes Mellitus, Surgery
- Keywords
- Diabetes mellitus, Surgery, Implementation, Quality of care, Quality indicators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored improvement strategy | Experimental | Other: Tailored improvement strategyIn 3 hospitals a tailored strategy to improve perioperative diabetes care is performed |
| Usual perioperative diabetes care | No intervention | –Three hospitals that provide usual perioperative diabetes care serve as control hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes mellitus AND
- Cardiac surgery OR
- Abdominal surgery OR
- Large joint orthopedic surgery And
- Duration of surgery minimum one hour
Key exclusion criteria (1 listed)
- Rejection to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored improvement strategyA 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. | Other | Tailored improvement strategy |
Primary outcome
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
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
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
2 secondary outcomes
current care study
Time frame: 1 year
feasibility study
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Derived from this study: PubMed 26384710Hommel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlies Hulscher, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored improvement strategy in people with Diabetes Mellitus and Surgery, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current care study (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01610674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.