AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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.

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 groups in NCT01384045
Study groupRoleWhat they receive
Usual CareNo interventionPatients continue to receive usual diabetes care without outreach by health promotions staff.
Arm 1-Health Promotoin OutreachExperimentalActive 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.

  1. Composite Measure of Guideline Concordance

    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

    Measured: After 1 year

Secondary outcomes (1)
  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.

  1. First posted28 Jun 2011 (estimated)
  2. Study startFeb 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in