NCT01773057

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 22, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 12, 2018

Status Verified

October 1, 2016

Enrollment Period

4.1 years

First QC Date

November 22, 2012

Last Update Submit

April 11, 2018

Conditions

Heart Failure

Keywords

Computerized Decision Support SystemHeart failureEffects on quality of careProcess of carePatient outcomes

Outcome Measures

Primary Outcomes (3)

  • Prescribing of ACE-inhibitors/Angiotensin II

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

    One year

  • Prescribing of beta blockers

    Percentage of heart failure patients that is prescribed beta blockers

    One year

  • Prescribing of diuretics

    Percentage of heart failure patients that is prescribed diuretics

    One year

Secondary Outcomes (2)

  • Hospital admissions

    One year

  • All cause mortality

    One year

Study Arms (2)

Active decision support

EXPERIMENTAL

Regular NHGDoc domains plus NHGDoc domain heart failure

Other: NHGDoc domain Heart Failure

Passive decision support

NO INTERVENTION

Regular NHGDoc domains

Interventions

NHGDoc domain Heart FailureOTHER

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

Active decision support

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre, IQ healthcare

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 26474603DERIVED

  • 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.

    PMID: 25322766DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Tijn Kool, PhD

    IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2012

First Posted

January 23, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

April 12, 2018

Record last verified: 2016-10

Locations

NL(1)