Effects of 'NHGDoc' on Quality of Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01773057
First received: November 22, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Heart Failure
Other: NHGDoc domain Heart Failure
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of the Computerized Decision Support System 'NHGDoc' on Quality of Care: a Cluster Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Prescribing of ACE-inhibitors/Angiotensin II [ Time Frame: One year ] [ Designated as safety issue: No ]
    Percentage of patients with heart failure that is prescribed ACE-inhibitors/Angiotensin II

  • Prescribing of beta blockers [ Time Frame: One year ] [ Designated as safety issue: No ]
    Percentage of heart failure patients that is prescribed beta blockers

  • Prescribing of diuretics [ Time Frame: One year ] [ Designated as safety issue: No ]
    Percentage of heart failure patients that is prescribed diuretics


Secondary Outcome Measures:
  • Hospital admissions [ Time Frame: One year ] [ Designated as safety issue: No ]
    Number of hospital admissions of patients with heart failure

  • All cause mortality [ Time Frame: One year ] [ Designated as safety issue: No ]
    Number of patients with heart failure that die within the hospital


Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active decision support
Regular NHGDoc domains plus NHGDoc domain heart failure
Other: 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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773057

Locations
Netherlands
Radboud University Nijmegen Medical Centre, IQ healthcare
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Principal Investigator: Marjolein Lugtenberg, PhD IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
Principal Investigator: Tijn Kool, PhD IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
  More Information

Additional Information:
No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01773057     History of Changes
Other Study ID Numbers: NHGDoc 2012
Study First Received: November 22, 2012
Last Updated: July 21, 2014
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Radboud University:
Computerized Decision Support System
Heart failure
Effects on quality of care
Process of care
Patient outcomes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014