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

May 22, 2014 updated by: Frans Boch Waldorff, Research Unit Of General Practice, Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital
      • Copenhagen, Capital, Denmark, 1014
        • Research Unit of General Practice
    • Capital Area
      • Copenhagen, Capital Area, Denmark, 1014
        • Frans Boch Waldorff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

General Practices working in the capital region in Denmark

Exclusion Criteria:

General Practices where the facilitator works.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change in annual systematic chronic disease controls per person affiliated with a primary care at a period at baseline and at 12 month.
Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICPC diagnosis coding
Time Frame: 12 months
Self reports regarding the use of ICPC diagnosis coding for Type 2 Diabetes and Chronic Obstructive Pulmonary Disease.
12 months
Sentinel Data Capture
Time Frame: 12 months
Application for the electronic Sentinel Data Capture module for overview of patients with chronic diseases.
12 months
Stratification
Time Frame: 12 months
The self reported use of stratification as part of primary care management of patients with chronic diseases
12 months
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)
Reduction in the number of practices with less than 1% annual systematic chronic disease follow up consultations.
Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Unit Of General Practice, Copenhagen

Collaborators

Region Capital Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP00990002

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.

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