Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Signal
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus focused on measuring type 2 diabetes mellitus, e-Health, allocation of care, clinical inertia, quality of care, patient satisfaction
Eligibility Criteria
Inclusion Criteria:
- patients with type 2 diabetes mellitus
- health care provider work within Diamuraal setting
Exclusion Criteria:
- none
Sites / Locations
- Diamuraal-associated GP practices
- Meander Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Signal
No signal
Arm Description
In addition to usual care, there will be an automatic signal in the electronic medical record (EMR) upon opening that will show the reader that the patient is currently not treated in the correct treatment setting and it simultaneously will give advice to which treatment allocation this patient should be transferred to.
Patients receive usual care, consisting of 4 office visits yearly
Outcomes
Primary Outcome Measures
The number of participants with change in allocation of care after intervention
One of the following:
shift from primary care to secondary care
shift from secondary care to primary care
continuation of treatment in primary care but with addition of e-consultation with secondary care
continuation of treatment in primary care but with replacement of one or more office visits in self-control
Secondary Outcome Measures
Assembly of reasons by health care providers for not following the guidelines
Change in quality of diabetes care
Measured with Quality of Care and Outcomes in Type 2 Diabetes scoring system (QuED) containing scores for biomedical data (HbA1c, blood pressure, lipids, medication regimen, number of measurements)
Change in diabetes treatment satisfaction
Measured with the diabetes treatment satisfaction questionnaire (DTSQ): six questions on satisfaction with treatment regimen and two questions on perceived frequency of hyperglycemia and hypoglycemia.
Number of participants who meet their treatment goals
Measured in number of goals that are met
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02229110
Brief Title
Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients
Official Title
Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with type 2 diabetes mellitus can receive care in the general practice or at the outpatient clinic. In the region of Amersfoort in The Netherlands, primary care practices and the hospital are connected through Diamuraal to organize the diabetes care in that region. They work in the same electronic medical record, and patients can request access to their own record (called a patient web portal). They set up Diamuraal guidelines, based on the guidelines of the Dutch College of General Practitioners and Internists, on where the patient care needs to be allocated (primary or secondary care), depending on the amount of specific care a patient needs. Despite guidelines, not all patients are treated in the correct place.
Our hypotheses is that when we improve triage we can cause a major shift from treatment in secondary care to primary care and from primary care to self-care by using the patient web portal. Furthermore, patients who needs extra attention due to problems with their diabetes or complications can receive this extra attention due to increased e-consultation between primary care and secondary care and if necessary actually can, during a short time, be treated by an internist. We hope to achieve this by introducing a signal in the electronic medical record. This signal allocates patients according to the guidelines and warns a physician if their patients is not treated according to that guideline. The health care provider can then discuss this situation with his patient. We believe that this leads to shift in allocation of care, in which optimal care is provided and patients are made more aware of their situation which hopefully leads to better self-management and satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
type 2 diabetes mellitus, e-Health, allocation of care, clinical inertia, quality of care, patient satisfaction
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2779 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Signal
Arm Type
Active Comparator
Arm Description
In addition to usual care, there will be an automatic signal in the electronic medical record (EMR) upon opening that will show the reader that the patient is currently not treated in the correct treatment setting and it simultaneously will give advice to which treatment allocation this patient should be transferred to.
Arm Title
No signal
Arm Type
No Intervention
Arm Description
Patients receive usual care, consisting of 4 office visits yearly
Intervention Type
Other
Intervention Name(s)
Signal
Intervention Description
Automatic signal in the electronic medical record
Primary Outcome Measure Information:
Title
The number of participants with change in allocation of care after intervention
Description
One of the following:
shift from primary care to secondary care
shift from secondary care to primary care
continuation of treatment in primary care but with addition of e-consultation with secondary care
continuation of treatment in primary care but with replacement of one or more office visits in self-control
Time Frame
One year
Secondary Outcome Measure Information:
Title
Assembly of reasons by health care providers for not following the guidelines
Time Frame
One year
Title
Change in quality of diabetes care
Description
Measured with Quality of Care and Outcomes in Type 2 Diabetes scoring system (QuED) containing scores for biomedical data (HbA1c, blood pressure, lipids, medication regimen, number of measurements)
Time Frame
One year
Title
Change in diabetes treatment satisfaction
Description
Measured with the diabetes treatment satisfaction questionnaire (DTSQ): six questions on satisfaction with treatment regimen and two questions on perceived frequency of hyperglycemia and hypoglycemia.
Time Frame
One year
Title
Number of participants who meet their treatment goals
Description
Measured in number of goals that are met
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with type 2 diabetes mellitus
health care provider work within Diamuraal setting
Exclusion Criteria:
- none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy EH Rutten, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lioe-Ting Dijkhorst-Oei, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maaike CM Ronda, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
Facility Information:
Facility Name
Diamuraal-associated GP practices
City
Amersfoort
Country
Netherlands
Facility Name
Meander Medical Center
City
Amersfoort
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
23777369
Citation
Ronda MC, Dijkhorst-Oei LT, Gorter KJ, Beulens JW, Rutten GE. Differences between diabetes patients who are interested or not in the use of a patient Web portal. Diabetes Technol Ther. 2013 Jul;15(7):556-63. doi: 10.1089/dia.2013.0023. Epub 2013 Jun 18.
Results Reference
background
Links:
URL
http://www.diamuraal.nl
Description
Related Info
Learn more about this trial
Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients
We'll reach out to this number within 24 hrs