Type II DiabetesNCT01384045
Outreach for Diabetes Cure
A study testing Health promotion outreach in people with Type II Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP), carry out a randomized-controlled trial of usual care versus an outreach intervention designed to increase guideline concordance with American… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Health promotion outreach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2011
- 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
- diagnosis of type II diabetes
- visit to University of Colorado Hospital in primary care clinic in last 18 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hopspital
Aurora, Colorado, 80045
About this study
Official title: Randomized Trial of Health Promotion Outreach for Diabetes Cure
Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP), carry out a randomized-controlled trial of usual care versus an outreach intervention designed to increase guideline concordance with American Diabetes Association (ADA) recommendations for blood pressure, Low-density lipoprotein (LDL), and glycosylated hemoglobin (A1c) goals, referrals for retinal exams, and aspirin therapy.Primary hypotheses: The proportion of patients meeting goal will be 10% higher in the intervention compared with control group in the following domains: 1. LDL<100 mg/dL; 2. A1c<7.0%; and 3. Systolic blood pressure<130 mm Hg or diastolic blood pressure<80 mm Hg.
Read the detailed description
Ten percent of all people over the age of 20, and 21% of all people over the age of 60, have diabetes. Diabetes is the sixth leading cause of death, and is one of the most prominent causes of heart disease, stroke, blindness, nephropathy, and neuropathy. Total health care expenditures for diabetes and its complications are enormous, amounting to more than $132 billion in direct and indirect costs in 2002. Nationally, substantial percentages of diabetic patients are not meeting ADA, Health Plan Employer Data and Information Set, (HEDIS), and Physician Quality Reporting Initiative (PQRI) guidelines for care that are intended to reduce morbidity and mortality associated with this disease. In order to improve these statistics, novel ways of delivering primary and secondary preventive diabetes care are needed. The growing use of electronic medical record systems and the ability to extract clinically-relevant information from administrative data sets offer powerful opportunities to identify patients who are "falling through the cracks," reach out to them proactively where they live, and render medical services and education in ways that maximize convenience and minimize barriers associated with sporadic and time-limited clinic visits.
The delivery of preventive and chronic disease services is sub-optimal in outpatient settings. Rates of guideline concordance for diabetes care within University of Colorado Hospital (UCH) are in most instances modestly better than national averages, yet there remains tremendous room for improvement. Clinic visits are often too brief for medical providers to review and arrange for all recommended care. Providers are frequently hampered by poorly-organized clinical data and a lack of automated reminders. Finally, many patients do not know about recommendations for care and prefer to focus on acute concerns during clinic visits.
Although decision support in the medical provider's office can improve guideline-based care for chronic illness, it does not improve outcomes among patients who fail to make clinic appointments or who make appointments for reasons unrelated to the illness. The investigators developed a health promotion outreach system (HPOS) to overcome many of these barriers. The purpose of HPOS is to increase access to and enhance the delivery of guideline-based care by communicating with patients outside of clinical settings.
Our diabetes-specific HPOS intervention incorporates the following key elements: (1) electronic queries of administrative claims to identify patients who are not up-to-date with recommended diabetes services; (2) mail and telephone outreach to alert patients about recommendations for care and facilitate the direct scheduling of primary care provider (PCP) visits, laboratory testing several days before PCP visits, and ophthalmology appointments; and (3) advance PCP notification regarding the intended diabetes focus of appointments arranged through the outreach process. The purpose of this study is to assess whether this intervention improves guideline concordance for LDL cholesterol, hemoglobin A1c, blood pressure, retinal examinations, and aspirin therapy as well as clinical attention to diabetes during primary care visits.
The investigators believe our intervention will reduce several barriers associated with usual care. First, the investigators reach out proactively to inform patients about recommendations for care instead of waiting for them to make appointments haphazardly and often for reasons unrelated to diabetes. The investigators make daytime and evening telephone calls to patients, many of whom are undoubtedly busy and forgetful, when they do not themselves call in response to letters that summarize personalized recommendations. The investigators schedule all laboratories and PCP visits at a single point in time, over the phone, and then send reminder postcards that summarize this information. Rather than completing laboratory testing during PCP visits and then requiring PCPs to convey recommendations for care several days later, the investigators schedule laboratories ahead of time whenever possible so that timely information will be available help guide clinical decision-making at the point of care. Finally, the investigators notify patients and PCPs in advance about the diabetes-specific purpose of scheduled appointments and specific areas needing clinical attention.
- Conditions
- Type II Diabetes
- Being tested
- Health promotion outreach
- Keywords
- Type II Diabetes, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion outreachOther
Calling patients who are due for diabetes related services, sending them an interventional letter and assisting them in getting over due serves.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients continue to receive usual diabetes care without outreach by health promotions staff. |
| Arm 1-Health Promotoin Outreach | Experimental | Active outreach by health promotion staff to send diabetes report card and schedule services including laboratory testing and visits. Receives: Other: Health promotion outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure of Guideline Concordance
Composite measure of guideline concordance with 1 point for concordance with each of the following:
- hemoglobin a1c less than 7%
- ldl cholesterol less than 100 mgs per decaliter
- urinary micro albumin measured in preceding 12 months
- both systolic bp less than 130 mms mercury \& diastolic bp less than 80 mms mercury
Measured: After 1 year
Secondary outcomes (1)
Individual measures of guideline concordance
Individual measures of guideline concordance. Assessment of the outcome measures of the composite measures separately.
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Ross, MD, Principal investigator, University of Colorado, DenverRazzaghi Mitra, MD, Principal investigator, University of Colorado, DenverLobo Ingrid, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384045
- Sponsor's protocol ID
- 08-0005
- Status last verified
- Jun 2011
- First submitted
- 27 Jun 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Health Promotion Outreach for Diabetes Cure
- ClinicalTrials.gov ID
- NCT01384045
- Acronym / sponsor ID
- 08-0005
- Conditions
- Type II Diabetes
- Keywords
- Type II Diabetes, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Jun 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.
Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP), carry out a randomized-controlled trial of usual care versus an outreach intervention designed to increase guideline concordance with American Diabetes Association (ADA) recommendations for blood pressure, Low-density lipoprotein (LDL), and glycosylated hemoglobin (A1c) goals, referrals for retinal exams, and aspirin therapy.Primary hypotheses: The proportion of patients meeting goal will be 10% higher in the intervention compared with control group in the following domains: 1. LDL<100 mg/dL; 2. A1c<7.0%; and 3. Systolic blood pressure<130 mm Hg or diastolic blood pressure<80 mm Hg.
Detailed description
Ten percent of all people over the age of 20, and 21% of all people over the age of 60, have diabetes. Diabetes is the sixth leading cause of death, and is one of the most prominent causes of heart disease, stroke, blindness, nephropathy, and neuropathy. Total health care expenditures for diabetes and its complications are enormous, amounting to more than $132 billion in direct and indirect costs in 2002. Nationally, substantial percentages of diabetic patients are not meeting ADA, Health Plan Employer Data and Information Set, (HEDIS), and Physician Quality Reporting Initiative (PQRI) guidelines for care that are intended to reduce morbidity and mortality associated with this disease. In order to improve these statistics, novel ways of delivering primary and secondary preventive diabetes care are needed. The growing use of electronic medical record systems and the ability to extract clinically-relevant information from administrative data sets offer powerful opportunities to identify patients who are "falling through the cracks," reach out to them proactively where they live, and render medical services and education in ways that maximize convenience and minimize barriers associated with sporadic and time-limited clinic visits.
The delivery of preventive and chronic disease services is sub-optimal in outpatient settings. Rates of guideline concordance for diabetes care within University of Colorado Hospital (UCH) are in most instances modestly better than national averages, yet there remains tremendous room for improvement. Clinic visits are often too brief for medical providers to review and arrange for all recommended care. Providers are frequently hampered by poorly-organized clinical data and a lack of automated reminders. Finally, many patients do not know about recommendations for care and prefer to focus on acute concerns during clinic visits.
Although decision support in the medical provider's office can improve guideline-based care for chronic illness, it does not improve outcomes among patients who fail to make clinic appointments or who make appointments for reasons unrelated to the illness. The investigators developed a health promotion outreach system (HPOS) to overcome many of these barriers. The purpose of HPOS is to increase access to and enhance the delivery of guideline-based care by communicating with patients outside of clinical settings.
Our diabetes-specific HPOS intervention incorporates the following key elements: (1) electronic queries of administrative claims to identify patients who are not up-to-date with recommended diabetes services; (2) mail and telephone outreach to alert patients about recommendations for care and facilitate the direct scheduling of primary care provider (PCP) visits, laboratory testing several days before PCP visits, and ophthalmology appointments; and (3) advance PCP notification regarding the intended diabetes focus of appointments arranged through the outreach process. The purpose of this study is to assess whether this intervention improves guideline concordance for LDL cholesterol, hemoglobin A1c, blood pressure, retinal examinations, and aspirin therapy as well as clinical attention to diabetes during primary care visits.
The investigators believe our intervention will reduce several barriers associated with usual care. First, the investigators reach out proactively to inform patients about recommendations for care instead of waiting for them to make appointments haphazardly and often for reasons unrelated to diabetes. The investigators make daytime and evening telephone calls to patients, many of whom are undoubtedly busy and forgetful, when they do not themselves call in response to letters that summarize personalized recommendations. The investigators schedule all laboratories and PCP visits at a single point in time, over the phone, and then send reminder postcards that summarize this information. Rather than completing laboratory testing during PCP visits and then requiring PCPs to convey recommendations for care several days later, the investigators schedule laboratories ahead of time whenever possible so that timely information will be available help guide clinical decision-making at the point of care. Finally, the investigators notify patients and PCPs in advance about the diabetes-specific purpose of scheduled appointments and specific areas needing clinical attention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients continue to receive usual diabetes care without outreach by health promotions staff. |
| Arm 1-Health Promotoin Outreach | Experimental | Other: Health promotion outreachActive outreach by health promotion staff to send diabetes report card and schedule services including laboratory testing and visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of type II diabetes
- visit to University of Colorado Hospital in primary care clinic in last 18 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Health promotion outreachCalling patients who are due for diabetes related services, sending them an interventional letter and assisting them in getting over due serves. | Other | Arm 1-Health Promotoin Outreach |
Primary outcome
Composite Measure of Guideline Concordance
Time frame: After 1 year
Composite measure of guideline concordance with 1 point for concordance with each of the following: 1. hemoglobin a1c less than 7% 2. ldl cholesterol less than 100 mgs per decaliter 3. urinary micro albumin measured in preceding 12 months 4. both systolic bp less than 130 mms mercury \& diastolic bp less than 80 mms mercury
1 secondary outcome
Individual measures of guideline concordance
Time frame: After 1 year
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 18 Dec 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.
Steven Ross, MD principal investigator
University of Colorado, Denver
Razzaghi Mitra, MD principal investigator
University of Colorado, Denver
Lobo Ingrid, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion outreach in people with Type II Diabetes, 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 2 inclusion and 0 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 18 Dec 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?
Composite Measure of Guideline Concordance (time frame: After 1 year). 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 18 Dec 2012.