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Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT02229110
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. G.E.H.M. Rutten, UMC Utrecht

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Signal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2779 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Signal
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.
Other: Signal
Automatic signal in the electronic medical record

No Intervention: No signal
Patients receive usual care, consisting of 4 office visits yearly



Primary Outcome Measures :
  1. The number of participants with change in allocation of care after intervention [ Time Frame: One year ]

    One of the following:

    1. shift from primary care to secondary care
    2. shift from secondary care to primary care
    3. continuation of treatment in primary care but with addition of e-consultation with secondary care
    4. continuation of treatment in primary care but with replacement of one or more office visits in self-control


Secondary Outcome Measures :
  1. Assembly of reasons by health care providers for not following the guidelines [ Time Frame: One year ]
  2. Change in quality of diabetes care [ Time Frame: One year ]
    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)

  3. Change in diabetes treatment satisfaction [ Time Frame: One year ]
    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.

  4. Number of participants who meet their treatment goals [ Time Frame: One year ]
    Measured in number of goals that are met



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with type 2 diabetes mellitus
  • health care provider work within Diamuraal setting

Exclusion Criteria:

- none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229110


Locations
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Netherlands
Diamuraal-associated GP practices
Amersfoort, Netherlands
Meander Medical Center
Amersfoort, Netherlands
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Guy EH Rutten, MD PhD UMC Utrecht
Study Director: Lioe-Ting Dijkhorst-Oei, MD, PhD UMC Utrecht
Study Director: Maaike CM Ronda, MD UMC Utrecht

Additional Information:
Publications:
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Responsible Party: Prof. G.E.H.M. Rutten, Professor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02229110     History of Changes
Other Study ID Numbers: 13-039/C
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Prof. G.E.H.M. Rutten, UMC Utrecht:
type 2 diabetes mellitus
e-Health
allocation of care
clinical inertia
quality of care
patient satisfaction
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases