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CompletedNCT01773057NHGDocUpdated Apr 12, 2018

Effects of 'NHGDoc' on Quality of Care

An interventional study of NHGDoc domain Heart Failure in Heart Failure, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
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Study summary

The purpose of this study is to determine whether the computerized decision support system 'NHGDoc' is effective in improving quality of primary care in terms of processes of care (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital admissions, mortality).

Read the detailed description

Computerized decision support systems are regarded as useful tools to improve quality of care, but their effects are still uncertain. In the Netherlands 'NHGDoc' a computerized decision support system supported by the Dutch College of General Practitioners (NHG) is currently being implemented among more than 1.000 general practices in the Netherlands.

The aim of this study is to evaluate the effects of NHGDoc on quality of care. In addition, we want to gain insight into the barriers and facilitators that affect the systems' impact.

A cluster randomized controlled trial will be conducted among 120 general practices in the Netherlands. Eligible practices will be randomized to receive either the regular NHGDoc modules (control arm) or the regular modules and an additional module on heart failure (intervention arm). The effect evaluation will focus on processes of care (e.g. prescription behavior) as well as on patient outcomes (e.g. hospital admissions, mortality). Additionally, a process evaluation will be conducted, which includes a focus group study and a survey among participating healthcare providers to evaluate the perceived barriers and facilitators to using 'NHGDoc'.

Results of this study will provide insight in the ability of computerized decision support systems and in particular 'NHGDoc' to improve quality of primary care. Whereas the trial focuses on a specific NHGDoc domain - heart failure - we believe our conclusions are relevant to other primary care areas as well, particularly as this study also explores the factors that contribute to the systems' effectiveness.

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Conditions studied

  • Heart Failure

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Keywords

  • Computerized Decision Support System
  • Heart failure
  • Effects on quality of care
  • Process of care
  • Patient outcomes
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 120 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • General practices should use the information system MicroHIS X or Promedico ASP
  • NHGDoc should be available in the general practices

Exclusion criteria

Exclusion Criteria:

  • General practices that do not meet the inclusion criteria
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Active decision support

    Regular NHGDoc domains plus NHGDoc domain heart failure

    Other: NHGDoc domain Heart Failure

  • No intervention
    Passive decision support

    Regular NHGDoc domains

Interventions

  • OtherNHGDoc domain Heart Failure

    Healthcare providers receive patient specific alerts in terms of diagnosing and treatment of patients with heart failure

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What researchers measure

Primary outcomes

  1. Prescribing of ACE-inhibitors/Angiotensin II

    Percentage of patients with heart failure that is prescribed ACE-inhibitors/Angiotensin II

    Time frame: One year

  2. Prescribing of beta blockers

    Percentage of heart failure patients that is prescribed beta blockers

    Time frame: One year

  3. Prescribing of diuretics

    Percentage of heart failure patients that is prescribed diuretics

    Time frame: One year

Secondary outcomes

  1. Hospital admissions

    Number of hospital admissions of patients with heart failure

    Time frame: One year

  2. All cause mortality

    Number of patients with heart failure that die within the hospital

    Time frame: One year

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Study locations

1 site
  • Radboud University Nijmegen Medical Centre, IQ healthcare
    Nijmegen, 6500 HB, Netherlands
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References and documents

Publications

  • Lugtenberg M, Pasveer D, van der Weijden T, Westert GP, Kool RB. Exposure to and experiences with a computerized decision support intervention in primary care: results from a process evaluation. BMC Fam Pract. 2015 Oct 16;16:141. doi: 10.1186/s12875-015-0364-0. PubMed 26474603 ↗
  • Lugtenberg M, Westert GP, Pasveer D, van der Weijden T, Kool RB. Evaluating the uptake and effects of the computerized decision support system NHGDoc on quality of primary care: protocol for a large-scale cluster randomized controlled trial. Implement Sci. 2014 Oct 17;9:145. doi: 10.1186/s13012-014-0145-5. PubMed 25322766 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01773057
Lead sponsor
Radboud University Medical Center
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
Responsible party
Sponsor
First posted
Jan 23, 2013
Start date
Apr 2013
Primary completion
May 2017
Completion
Sep 2017
Last update
Apr 12, 2018

Study contacts

Tijn Kool, PhD
principal investigator · IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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