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Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial (Output)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Research Unit Of General Practice, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Region Capital Denmark
Information provided by:
Research Unit Of General Practice, Copenhagen
ClinicalTrials.gov Identifier:
NCT01297075
First received: February 15, 2011
Last updated: March 3, 2011
Last verified: February 2011
History of Changes
  Purpose

The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice.

The Facilitator Project is funded by The Danish Ministry of Interior and Health.


Condition Intervention
Chronic Disease
 Behavioral: Outreach visits

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Research Unit Of General Practice, Copenhagen:

Primary Outcome Measures:
  • Change from baseline at 12 month in Annual systematic chronic disease follow up consultations [ Time Frame: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention) ] [ Designated as safety issue: No ]
    Change in annual systematic chronic disease controls per person affiliated with a primary care at a period at baseline and at 12 month.


Secondary Outcome Measures:
  • ICPC diagnosis coding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Self reports regarding the use of ICPC diagnosis coding for Type 2 Diabetes and Chronic Obstructive Pulmonary Disease.

  • Sentinel Data Capture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Application for the electronic Sentinel Data Capture module for overview of patients with chronic diseases.

  • Stratification [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The self reported use of stratification as part of primary care management of patients with chronic diseases

  • Change from baseline and at 12 month in practices with low performance on annual systematic chronic disease follow up consultations. [ Time Frame: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention) ] [ Designated as safety issue: No ]
    Reduction in the number of practices with less than 1% annual systematic chronic disease follow up consultations.


Estimated Enrollment: 180
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Outreach visits
Practices allocated to outreach visits may receive up to three outreach visits in order to motivate and support general practice clinics in implementing two chronic care programmes for chronic obstructive Pulmonary disease and Type 2 diabetes.
 Behavioral: Outreach visits
The 16 facilitators in the project attend an educational programme designed to provide them with the necessary skills and tools for the task. The facilitators visit general practice clinics from March 2011 until the end of 2012. Each clinic is offered three visits. The facilitator is to act as a change agent who motivates and helps the clinic team in the process of defining common goals, and choosing the appropriate means for achieving them.
No Intervention: Control (late intervention)
These practices are allocated to outreach visits after the initial evaluation stops at 12 months.

Detailed Description:

In a cluster randomized trial the investigators will explore the efficacy of up to three outreach visits by specially trained GPs. Efficacy data are obtained by means of questionnaires at regional databases.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

General Practices working in the capital region in Denmark

Exclusion Criteria:

General Practices where the facilitator works.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297075

Contacts
Contact: Frans B Waldorff, PhD +4535327171 fransw@sund.ku.dk

Locations
Denmark
Frans Boch Waldorff Recruiting
Copenhagen, Capital Area, Denmark, 1014
Research Unit of General Practice Not yet recruiting
Copenhagen, Capital, Denmark, 1014
Contact: Frans B Waldorff, PhD     +45 35327171     fransw@sund.ku.dk    
Principal Investigator: Frans B Waldorff, PhD            
Sponsors and Collaborators
Research Unit Of General Practice, Copenhagen
Region Capital Denmark
Investigators
Principal Investigator: Frans B Waldorff, PhD Research Unit of General Practice
  More Information

No publications provided

Responsible Party: Frans B Waldorff, Research Unit of General Practice
ClinicalTrials.gov Identifier: NCT01297075     History of Changes
Other Study ID Numbers: GP00990002
Study First Received: February 15, 2011
Last Updated: March 3, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Research Unit Of General Practice, Copenhagen:
Health Services Research
Chronic Care
Outreach Visits
Primary care
chronic disease management

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013