Chronic DiseaseOutputNCT01297075
Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
A study testing Outreach visits in people with Chronic Disease, run by Research Unit Of General Practice, Copenhagen at 2 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Outreach visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General Practices working in the capital region in Denmark
Who cannot join
- General Practices where the facilitator works.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Frans Boch Waldorff
Copenhagen, Capital Area, 1014
Research Unit of General Practice
Copenhagen, Capital, 1014
About this study
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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Outreach visits
- Keywords
- Health Services Research, Chronic Care, Outreach Visits, Primary care, chronic disease management
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach visitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Outreach visits | Experimental | 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. Receives: Behavioral: Outreach visits |
| Control (late intervention) | No intervention | These practices are allocated to outreach visits after the initial evaluation stops at 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)
Secondary outcomes (4)
ICPC diagnosis coding
Self reports regarding the use of ICPC diagnosis coding for Type 2 Diabetes and Chronic Obstructive Pulmonary Disease.
Measured: 12 months
Sentinel Data Capture
Application for the electronic Sentinel Data Capture module for overview of patients with chronic diseases.
Measured: 12 months
Stratification
The self reported use of stratification as part of primary care management of patients with chronic diseases
Measured: 12 months
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.
Measured: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Unit Of General Practice, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Region Capital Denmark
- Responsible party
- Principal investigator, Frans Boch Waldorff, Research Unit Of General Practice, Copenhagen
- Investigators
- Frans B Waldorff, PhD, Principal investigator, Research Unit of General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297075
- Sponsor's protocol ID
- GP00990002
- Acronym
- Output
- Status last verified
- Feb 2011
- First submitted
- 15 Feb 2011
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24716545
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01297075
- Acronym / sponsor ID
- Output / GP00990002
- Conditions
- Chronic Disease
- Keywords
- Health Services Research, Chronic Care, Outreach Visits, Primary care, chronic disease management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Research Unit Of General Practice, CopenhagenUniversity, hospital or other
- Collaborators
- Region Capital Denmark
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outreach visits | Experimental | Behavioral: Outreach visitsPractices 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. |
| Control (late intervention) | No intervention | –These practices are allocated to outreach visits after the initial evaluation stops at 12 months. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- General Practices working in the capital region in Denmark
Key exclusion criteria (1 listed)
- General Practices where the facilitator works.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outreach visitsThe 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. | Behavioural | Outreach visits |
Primary outcome
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.
4 secondary outcomes
ICPC diagnosis coding
Time frame: 12 months
Sentinel Data Capture
Time frame: 12 months
Stratification
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
- Derived from this study: PubMed 24716545Due 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans B Waldorff, PhD principal investigator
Research Unit of General Practice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outreach visits in people with Chronic Disease, run by Research Unit Of General Practice, Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01297075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.