CClinicalTrials.gg
CompletedNCT02229110Updated Jun 16, 2015

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

An interventional study of Signal in Diabetes Mellitus, sponsored by UMC Utrecht. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-16.

Sponsored by UMC Utrecht · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,779
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus

Keywords

  • type 2 diabetes mellitus
  • e-Health
  • allocation of care
  • clinical inertia
  • quality of care
  • patient satisfaction
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 2,779 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,779 participants (actual)

Study arms

  • 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

  • No intervention
    No signal

    Patients receive usual care, consisting of 4 office visits yearly

Interventions

  • OtherSignal

    Automatic signal in the electronic medical record

06

What researchers measure

Primary outcomes

  1. The number of participants with change in allocation of care after intervention

    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

    Time frame: One year

Secondary outcomes

  1. Assembly of reasons by health care providers for not following the guidelines

    Time frame: One year

  2. 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)

    Time frame: One year

  3. 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.

    Time frame: One year

  4. Number of participants who meet their treatment goals

    Measured in number of goals that are met

    Time frame: One year

07

Study locations

2 sites
  • Diamuraal-associated GP practices
    Amersfoort, Netherlands
  • Meander Medical Center
    Amersfoort, Netherlands
08

References and documents

Publications

  • 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. PubMed 23777369 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02229110
Lead sponsor
UMC Utrecht
Responsible party
Prof. G.E.H.M. Rutten (Professor, UMC Utrecht) — Principal investigator
First posted
Aug 29, 2014
Start date
Oct 2013
Primary completion
Oct 2014
Completion
Mar 2015
Last update
Jun 16, 2015

Study contacts

Guy EH Rutten, MD PhD
principal investigator · UMC Utrecht
Lioe-Ting Dijkhorst-Oei, MD, PhD
study director · UMC Utrecht
Maaike CM Ronda, MD
study director · UMC Utrecht

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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