DiabetesNCT00827710
Automated Diabetes Registry Tools to Enhance Patient Self-Management and Provider Performance Feedback
A study testing point of care patient report cards and Provider performance report card in people with Diabetes, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care distribution of report cards to patients and 3) provider performance feedback with patient level data? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- point of care patient report cards and Provider performance report card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,457 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to May 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- icd9 code for diabetes
- primary care visit in the past 18 months
- English or Spanish as primary language
Who cannot join
- age more than 75
- No working address
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care distribution of report cards to patients and 3) provider performance feedback with patient level data?
Read the detailed description
Our federally qualified health care center serves over 7000 diabetic patients, many of whom are uninsured (43%) or on medicaid (18%) or medicare (26%). The population is 54% Latino, 25% Caucasian, and 14% African American. We excluded patients older than 75; those without English or Spanish as a first language; and the homeless. The remaining 5457 patients were randomized to this one-year study which ended January 1, 2009. One-half of the enrolled patients received quarterly mailed report cards on their HgA1c, blood pressure, and lipid performance. They were asked to pick from a list of self-management goals and to see their provider if their last visit was more than 2 months prior to the mailing. In a 2x2 design, our eight clinics were randomized to i) on-site printing of patient report cards or no on-site printing and ii) standard provider performance report cards or enhanced provider report cards. The standard provider report cards included data on provider performance on HgA1c, LDL, and blood pressure compared to other providers. The enhanced provider report card also included a list of up to 10 patients not at HgA1c, LDL, or blood pressure goal. The provider report cards were distributed on a quarterly basis, and the point of care patient report cards were distributed at every clinic visit.
We are analyzing the impact of the intervention on the percent of patients at expert recommended goals for glycemic, lipid, and blood pressure control. We are also performing a qualitative analysis to describe provider and patient attitudes toward the interventions.
- Conditions
- Diabetes
- Being tested
- point of care patient report cards, Provider performance report card
- Keywords
- diabetes, registry, computer, self management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point of care patient report cardsBehavioural
gives patient feedback on performance on glycemic, lipid, and blood pressure control relative to expert recommended goals
Provider performance report cardBehavioural
Gives provider feedback on performance on their diabetes panel of patients and includes patient level data
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients who received point-of-care report cards and were listed on provider performance report card Receives: Behavioral: point of care patient report cards; Behavioral: Provider performance report card |
| 2 | Active comparator | Patients who received point-of-care diabetes report cards but were not listed on provider performance report card Receives: Behavioral: point of care patient report cards |
| 3 | Active comparator | Patients who did not receive point-of-care report card but who were listed on provider performance report card Receives: Behavioral: Provider performance report card |
| 4 | No intervention | Patients who did not receive point of care report card and who did were not listed on provider performance report card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with HgA1c < 7
Measured: january 2009
Percent of patients with LDL < 100 mg/dL
Measured: january 2009
Percent of patients with BP < 130/80
Measured: january 2009
Secondary outcomes (3)
Percent of patients with A1c checked in last 6 months
Measured: january 2009
Percent of patients with LDL checked in past year
Measured: january 2009
Percent of patients with BP checked in past year
Measured: january 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startDec 2007
- Primary completionJan 2009
- Study completionMay 2009
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 DiabetesStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 5,457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Henry Fischer, Denver Health and Hospital Authority
- Investigators
- henry h fischer, md, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827710
- Sponsor's protocol ID
- AHRQ 290-2006-000-20
- Other IDs
- AHRQ Contract 290-2006-000-20
- Status last verified
- Apr 2012
- First submitted
- 14 Jan 2009
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischer HH, Eisert SL, Durfee MJ, Moore SL, Steele AW, McCullen K, Anderson K, Penny L, Mackenzie TD. The impact of tailored diabetes registry report cards on measures of disease control: a nested randomized trial. BMC Med Inform Decis Mak. 2011 Feb 17;11:12. doi: 10.1186/1472-6947-11-12.
PubMed 21329495
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Diabetes Registry Tools to Enhance Patient Self-Management and Provider Performance Feedback
- ClinicalTrials.gov ID
- NCT00827710
- Acronym / sponsor ID
- AHRQ 290-2006-000-20
- Conditions
- Diabetes
- Keywords
- diabetes, registry, computer, self management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,457 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Jan 2009 (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.
Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care distribution of report cards to patients and 3) provider performance feedback with patient level data?
Detailed description
Our federally qualified health care center serves over 7000 diabetic patients, many of whom are uninsured (43%) or on medicaid (18%) or medicare (26%). The population is 54% Latino, 25% Caucasian, and 14% African American. We excluded patients older than 75; those without English or Spanish as a first language; and the homeless. The remaining 5457 patients were randomized to this one-year study which ended January 1, 2009. One-half of the enrolled patients received quarterly mailed report cards on their HgA1c, blood pressure, and lipid performance. They were asked to pick from a list of self-management goals and to see their provider if their last visit was more than 2 months prior to the mailing. In a 2x2 design, our eight clinics were randomized to i) on-site printing of patient report cards or no on-site printing and ii) standard provider performance report cards or enhanced provider report cards. The standard provider report cards included data on provider performance on HgA1c, LDL, and blood pressure compared to other providers. The enhanced provider report card also included a list of up to 10 patients not at HgA1c, LDL, or blood pressure goal. The provider report cards were distributed on a quarterly basis, and the point of care patient report cards were distributed at every clinic visit.
We are analyzing the impact of the intervention on the percent of patients at expert recommended goals for glycemic, lipid, and blood pressure control. We are also performing a qualitative analysis to describe provider and patient attitudes toward the interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: point of care patient report cards, Behavioral: Provider performance report cardpatients who received point-of-care report cards and were listed on provider performance report card |
| 2 | Active comparator | Behavioral: point of care patient report cardsPatients who received point-of-care diabetes report cards but were not listed on provider performance report card |
| 3 | Active comparator | Behavioral: Provider performance report cardPatients who did not receive point-of-care report card but who were listed on provider performance report card |
| 4 | No intervention | –Patients who did not receive point of care report card and who did were not listed on provider performance report card |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- icd9 code for diabetes
- primary care visit in the past 18 months
- English or Spanish as primary language
Key exclusion criteria (2 listed)
- age more than 75
- No working address
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 |
|---|---|---|
| point of care patient report cardsgives patient feedback on performance on glycemic, lipid, and blood pressure control relative to expert recommended goals | Behavioural | 1, 2 |
| Provider performance report cardGives provider feedback on performance on their diabetes panel of patients and includes patient level data | Behavioural | 1, 3 |
Primary outcome
Percent of patients with HgA1c < 7
Time frame: january 2009
Percent of patients with LDL < 100 mg/dL
Time frame: january 2009
Percent of patients with BP < 130/80
Time frame: january 2009
3 secondary outcomes
Percent of patients with A1c checked in last 6 months
Time frame: january 2009
Percent of patients with LDL checked in past year
Time frame: january 2009
Percent of patients with BP checked in past year
Time frame: january 2009
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 1 May 2012.
- Derived from this study: PubMed 21329495Fischer HH, Eisert SL, Durfee MJ, Moore SL, Steele AW, McCullen K, Anderson K, Penny L, Mackenzie TD. The impact of tailored diabetes registry report cards on measures of disease control: a nested randomized trial. BMC Med Inform Decis Mak. 2011 Feb 17;11:12. doi: 10.1186/1472-6947-11-12.
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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.
henry h fischer, md principal investigator
Denver Health and Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing point of care patient report cards and Provider performance report card in people with Diabetes, run by Denver Health and Hospital Authority 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 3 inclusion and 2 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 1 May 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?
Percent of patients with HgA1c < 7 (time frame: january 2009). The study lists 3 primary outcomes in all. 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 NCT00827710, 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 1 May 2012.