NCT02229110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,779

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

August 27, 2014

Last Update Submit

June 15, 2015

Conditions

Keywords

type 2 diabetes mellituse-Healthallocation of careclinical inertiaquality of carepatient satisfaction

Outcome Measures

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

    One year

Secondary Outcomes (4)

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

    One year

  • Change in quality of diabetes care

    One year

  • Change in diabetes treatment satisfaction

    One year

  • Number of participants who meet their treatment goals

    One year

Study Arms (2)

Signal

ACTIVE COMPARATOR

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 signal

NO INTERVENTION

Patients receive usual care, consisting of 4 office visits yearly

Interventions

SignalOTHER

Automatic signal in the electronic medical record

Signal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diamuraal-associated GP practices

Amersfoort, Netherlands

Location

Meander Medical Center

Amersfoort, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 23777369BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Patient Satisfaction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Guy EH Rutten, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR
  • Lioe-Ting Dijkhorst-Oei, MD, PhD

    UMC Utrecht

    STUDY DIRECTOR
  • Maaike CM Ronda, MD

    UMC Utrecht

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations