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

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Outreach visits
Sponsored by
Research Unit Of General Practice, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring Health Services Research, Chronic Care, Outreach Visits, Primary care, chronic disease management

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

General Practices working in the capital region in Denmark

Exclusion Criteria:

General Practices where the facilitator works.

Sites / Locations

  • Frans Boch Waldorff
  • Research Unit of General Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Outreach visits

Control (late intervention)

Arm Description

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.

These practices are allocated to outreach visits after the initial evaluation stops at 12 months.

Outcomes

Primary Outcome Measures

Change from baseline at 12 month in Annual systematic chronic disease follow up consultations
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
Self reports regarding the use of ICPC diagnosis coding for Type 2 Diabetes and Chronic Obstructive Pulmonary Disease.
Sentinel Data Capture
Application for the electronic Sentinel Data Capture module for overview of patients with chronic diseases.
Stratification
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.
Reduction in the number of practices with less than 1% annual systematic chronic disease follow up consultations.

Full Information

First Posted
February 15, 2011
Last Updated
May 22, 2014
Sponsor
Research Unit Of General Practice, Copenhagen
Collaborators
Region Capital Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01297075
Brief Title
Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
Acronym
Output
Official Title
Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Unit Of General Practice, Copenhagen
Collaborators
Region Capital Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Health Services Research, Chronic Care, Outreach Visits, Primary care, chronic disease management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outreach visits
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (late intervention)
Arm Type
No Intervention
Arm Description
These practices are allocated to outreach visits after the initial evaluation stops at 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Outreach visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline at 12 month in Annual systematic chronic disease follow up consultations
Description
Change in annual systematic chronic disease controls per person affiliated with a primary care at a period at baseline and at 12 month.
Time Frame
Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)
Secondary Outcome Measure Information:
Title
ICPC diagnosis coding
Description
Self reports regarding the use of ICPC diagnosis coding for Type 2 Diabetes and Chronic Obstructive Pulmonary Disease.
Time Frame
12 months
Title
Sentinel Data Capture
Description
Application for the electronic Sentinel Data Capture module for overview of patients with chronic diseases.
Time Frame
12 months
Title
Stratification
Description
The self reported use of stratification as part of primary care management of patients with chronic diseases
Time Frame
12 months
Title
Change from baseline and at 12 month in practices with low performance on annual systematic chronic disease follow up consultations.
Description
Reduction in the number of practices with less than 1% annual systematic chronic disease follow up consultations.
Time Frame
Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: General Practices working in the capital region in Denmark Exclusion Criteria: General Practices where the facilitator works.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans B Waldorff, PhD
Organizational Affiliation
Research Unit of General Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frans Boch Waldorff
City
Copenhagen
State/Province
Capital Area
ZIP/Postal Code
1014
Country
Denmark
Facility Name
Research Unit of General Practice
City
Copenhagen
State/Province
Capital
ZIP/Postal Code
1014
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24716545
Citation
Due TD, Thorsen T, Kousgaard MB, Siersma VD, Waldorff FB. The effectiveness of a semi-tailored facilitator-based intervention to optimise chronic care management in general practice: a stepped-wedge randomised controlled trial. BMC Fam Pract. 2014 Apr 9;15:65. doi: 10.1186/1471-2296-15-65.
Results Reference
derived

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

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