- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773057
Effects of 'NHGDoc' on Quality of Care (NHGDoc)
Effects of the Computerized Decision Support System 'NHGDoc' on Quality of Care: a Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nijmegen, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre, IQ healthcare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- General practices should use the information system MicroHIS X or Promedico ASP
- NHGDoc should be available in the general practices
Exclusion Criteria:
- General practices that do not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Active decision support
Regular NHGDoc domains plus NHGDoc domain heart failure
|
Healthcare providers receive patient specific alerts in terms of diagnosing and treatment of patients with heart failure
|
|
NO_INTERVENTION: Passive decision support
Regular NHGDoc domains
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prescribing of ACE-inhibitors/Angiotensin II
Time Frame: One year
|
Percentage of patients with heart failure that is prescribed ACE-inhibitors/Angiotensin II
|
One year
|
|
Prescribing of beta blockers
Time Frame: One year
|
Percentage of heart failure patients that is prescribed beta blockers
|
One year
|
|
Prescribing of diuretics
Time Frame: One year
|
Percentage of heart failure patients that is prescribed diuretics
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital admissions
Time Frame: One year
|
Number of hospital admissions of patients with heart failure
|
One year
|
|
All cause mortality
Time Frame: One year
|
Number of patients with heart failure that die within the hospital
|
One year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tijn Kool, PhD, IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHGDoc 2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
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University of Health Sciences LahoreRecruitingAcute Decompensated Heart Failure | Heart Failure, Diastolic | Heart Failure, SystolicPakistan
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Indiana UniversityRecruitingCongestive Heart Failure | Congestive Heart Failure (CHF) | Congestive Heart Failure Chronic | Congestive Heart Failure(CHF)United States
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
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Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
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Lakeland Regional Health Systems, Inc.RecruitingHeart Failure | Heart Failure Acute | Acute Heart Failure (AHF) | Heart Failure - NYHA II - IVUnited States
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Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
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VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
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Eli Lilly and CompanyNot yet recruitingHeart Failure | Heart Failure, Diastolic | Heart Failure, SystolicUnited States, Japan
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Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
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Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
Clinical Trials on NHGDoc domain Heart Failure
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Naile ALANKAYANot yet recruitingHeart Diseases | Heart FailureTurkey
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University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI)CompletedCongestive Heart Failure | Cardiac FailureUnited States
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Johns Hopkins UniversityNational Institute of Nursing Research (NINR)CompletedHeart FailureUnited States
-
Jana CareMassachusetts General HospitalCompletedHeart FailureUnited States
-
University of FloridaCompletedHeart FailureUnited States
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Novartis PharmaceuticalsCompleted
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University College, LondonBritish Society for Heart Failure; National Institute for Cardiovascular Outcomes...UnknownHeart FailureUnited Kingdom
-
Columbia UniversityMedtronicCompletedCongestive Heart Failure | ArrhythmiasUnited States
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Sherief Abd-ElsalamRecruiting