Type 2 DiabetesULTRA-DM/MDDNCT00414986
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
A study testing Standard CQI intervention, Chronic Care Improvement (CCI) Intervention and Self-directed practice comparison in people with Type 2 Diabetes and Hyperlipidemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The study will randomize 54 primary care practices to two intervention and a comparison groups. Both interventions will involve an on-site Improvement Facilitator who will assist the practice in forming an Improvement Team, using rapid-cycle tests of change, and implementing chronic care office systems for type 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Hyperlipidemia, Hypertension
- What is being tested?
- Standard CQI intervention, Chronic Care Improvement (CCI) Intervention and Self-directed practice comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,565 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under primary care for type 2 diabetes
Who cannot join
- Are not minimally literate in either English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Denver, Colorado, 80045
About this study
Official title: Using Learning Teams for Reflective Adaptation
The study will randomize 54 primary care practices to two intervention and a comparison groups. Both interventions will involve an on-site Improvement Facilitator who will assist the practice in forming an Improvement Team, using rapid-cycle tests of change, and implementing chronic care office systems for type 2 diabetes and depression. One intervention is based on complexity science and the other is a traditional QI intervention.
Read the detailed description
Evidence-based guidelines for primary care of diabetes have been established and disseminated, yet adoption of guidelines in community-based primary care practice has been disappointing. This effectiveness study proposes a randomized trial involving 54 community-based primary care practices to test two innovative interventions to improve diabetes and depression care. One intervention, derived from theoretically based and efficacious programs tested in other settings, adopts a broad focus and seeks to improve diabetes and depression care by a) increasing the practice's organizational capacity to manage change, and b) implementing and sustaining chronic care office systems that support clinician efforts to improve care for diabetes. The intervention will combine two integrated components. The first component will utilize an Improvement Facilitator that will assess the practice's current use of chronic care office systems and their organizational capacity to manage change, provide feedback to key stakeholders in the practice, and work with the practice over six months to form an Improvement Team that will both address organizational capacity to create and sustain improvement and implement chronic care systems. In the second component of the intervention, the practice will participate in a local Improvement Collaborative that will afford opportunities to learn and share experiences during implementation and maintenance phases of the intervention with five similar practices in their geographic area. The second intervention is based on traditional QI methods and focuses on a chronic disease registry with regular reports to the physicians. It also uses PDSA cycles to assist in implementing change. This intervention will offer tools to improve diabetes and/or asthma care. Both interventions will be evaluated in two ways. First, a randomized trial using rigorous quantitative methods will measure 2 primary and 3 secondary endpoints at 9 and 18 months, including a) the ADA Physician Recognition Program performance measures by both patient-report and review of the medical record, and b) HEDIS measures of acute phase management of depression, c) assessment of the extent to which practices implement and physicians use elements of the chronic care model in their care of diabetes and depression. Change from baseline to 9 months will assess adoption of chronic care improvements, and change from 9 to 18 months will assess sustainability of improvements. Second, a multimethod assessment process will be used to analyze all qualitative and quantitative data separately to understand how and why the intervention led to the observed effects. The practice assessment will strive to understand which components of the interventions were most effective, their relative costs for implementation, and how they might be further improved. Successful components of the intervention will be refined and made available to our collaborators in the project; the Copic Insurance Company and the Colorado Clinical Guidelines Collaborative, for use in their statewide activities to improve diabetes care.
- Conditions
- Type 2 Diabetes, Hyperlipidemia, Hypertension, Depression
- Being tested
- Standard CQI intervention, Chronic Care Improvement (CCI) Intervention, Self-directed practice comparison
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperlipidemias, Hypertension, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CQI interventionBehavioural
In-practice change facilitator assists the practice in implementing a chronic disease registry
Chronic Care Improvement (CCI) InterventionBehavioural
An in-practice change facilitator will assist the Improvement Team in enhancing the relationship infrastructure of the practice and in implementing diabetes and depression office systems.
Self-directed practice comparisonBehavioural
Practices will have access to all tools used in Arm 1 via a project website
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Practice in this arm will receive the Chronic Care Improvement intervention Receives: Behavioral: Chronic Care Improvement (CCI) Intervention |
| 2 | Experimental | Practices in this arm will receive the standard CQI intervention. An in-practice CQI coordinator will assist the practices in implement a chronic disease registry. Receives: Behavioral: Standard CQI intervention |
| 3 | Active comparator | Practice in this arm will have access to all chronic care tools, but will not have an in-practice change agent. Receives: Behavioral: Self-directed practice comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care
Measured: Baseline, 9, and 18 month
HEDIS-like measures of acute phase management of depression
Measured: Baseline, 9, and 18 months
Secondary outcomes (1)
Patient report (by survey) of their primary care experience
Measured: baseline, 9-months, 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startSep 2005
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 1,565 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- David West, PhD, Principal investigator, Department of Family Medicine, University of Colorado Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414986
- Sponsor's protocol ID
- 05-0457
- Other IDs
- R18DK067083, MH069806
- Acronym
- ULTRA-DM/MDD
- Status last verified
- Nov 2012
- First submitted
- 21 Dec 2006
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Learning Teams for Reflective Adaptation
- ClinicalTrials.gov ID
- NCT00414986
- Acronym / sponsor ID
- ULTRA-DM/MDD / 05-0457
- Conditions
- Type 2 Diabetes, Hyperlipidemia, Hypertension, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,565 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH)
- Study start
- Sep 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Dec 2006 (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 study will randomize 54 primary care practices to two intervention and a comparison groups. Both interventions will involve an on-site Improvement Facilitator who will assist the practice in forming an Improvement Team, using rapid-cycle tests of change, and implementing chronic care office systems for type 2 diabetes and depression. One intervention is based on complexity science and the other is a traditional QI intervention.
Detailed description
Evidence-based guidelines for primary care of diabetes have been established and disseminated, yet adoption of guidelines in community-based primary care practice has been disappointing. This effectiveness study proposes a randomized trial involving 54 community-based primary care practices to test two innovative interventions to improve diabetes and depression care. One intervention, derived from theoretically based and efficacious programs tested in other settings, adopts a broad focus and seeks to improve diabetes and depression care by a) increasing the practice's organizational capacity to manage change, and b) implementing and sustaining chronic care office systems that support clinician efforts to improve care for diabetes. The intervention will combine two integrated components. The first component will utilize an Improvement Facilitator that will assess the practice's current use of chronic care office systems and their organizational capacity to manage change, provide feedback to key stakeholders in the practice, and work with the practice over six months to form an Improvement Team that will both address organizational capacity to create and sustain improvement and implement chronic care systems. In the second component of the intervention, the practice will participate in a local Improvement Collaborative that will afford opportunities to learn and share experiences during implementation and maintenance phases of the intervention with five similar practices in their geographic area. The second intervention is based on traditional QI methods and focuses on a chronic disease registry with regular reports to the physicians. It also uses PDSA cycles to assist in implementing change. This intervention will offer tools to improve diabetes and/or asthma care. Both interventions will be evaluated in two ways. First, a randomized trial using rigorous quantitative methods will measure 2 primary and 3 secondary endpoints at 9 and 18 months, including a) the ADA Physician Recognition Program performance measures by both patient-report and review of the medical record, and b) HEDIS measures of acute phase management of depression, c) assessment of the extent to which practices implement and physicians use elements of the chronic care model in their care of diabetes and depression. Change from baseline to 9 months will assess adoption of chronic care improvements, and change from 9 to 18 months will assess sustainability of improvements. Second, a multimethod assessment process will be used to analyze all qualitative and quantitative data separately to understand how and why the intervention led to the observed effects. The practice assessment will strive to understand which components of the interventions were most effective, their relative costs for implementation, and how they might be further improved. Successful components of the intervention will be refined and made available to our collaborators in the project; the Copic Insurance Company and the Colorado Clinical Guidelines Collaborative, for use in their statewide activities to improve diabetes care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Chronic Care Improvement (CCI) InterventionPractice in this arm will receive the Chronic Care Improvement intervention |
| 2 | Experimental | Behavioral: Standard CQI interventionPractices in this arm will receive the standard CQI intervention. An in-practice CQI coordinator will assist the practices in implement a chronic disease registry. |
| 3 | Active comparator | Behavioral: Self-directed practice comparisonPractice in this arm will have access to all chronic care tools, but will not have an in-practice change agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Under primary care for type 2 diabetes
Key exclusion criteria (1 listed)
- Are not minimally literate in either English or Spanish
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 |
|---|---|---|
| Standard CQI interventionIn-practice change facilitator assists the practice in implementing a chronic disease registry | Behavioural | 2 |
| Chronic Care Improvement (CCI) InterventionAn in-practice change facilitator will assist the Improvement Team in enhancing the relationship infrastructure of the practice and in implementing diabetes and depression office systems. | Behavioural | 1 |
| Self-directed practice comparisonPractices will have access to all tools used in Arm 1 via a project website | Behavioural | 3 |
Primary outcome
Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care
Time frame: Baseline, 9, and 18 month
HEDIS-like measures of acute phase management of depression
Time frame: Baseline, 9, and 18 months
1 secondary outcome
Patient report (by survey) of their primary care experience
Time frame: baseline, 9-months, 18-months
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 22 Nov 2012.
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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.
David West, PhD principal investigator
Department of Family Medicine, University of Colorado Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard CQI intervention, Chronic Care Improvement (CCI) Intervention and Self-directed practice comparison in people with Type 2 Diabetes and Hyperlipidemia, run by University of Colorado, Denver at 1 site in United States.
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 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care (time frame: Baseline, 9, and 18 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2012.