DiabetesNCT01113099
Improving Adherence to Prescribing Guidelines for Cholesterol Lowering in Hospitalized Diabetic Patients
A study testing Academic detailing in people with Diabetes and Dyslipidemia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
We hypothesize that when compared to usual care a greater proportion of hospitalized diabetic patients who are candidates for cholesterol lowering will be discharged with a prescription for a statin if their physicians are contacted by a pharmacist to discuss treatment guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Dyslipidemia
- What is being tested?
- Academic detailing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2007
- 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
- Hospitalized patients with diabetes
- LDL >= 100
Who cannot join
- Terminal illness
- Pregnancy
- Intolerance or contraindication to statin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assisted Detailing to Improve Guideline Adherence
We hypothesize that when compared to usual care a greater proportion of hospitalized diabetic patients who are candidates for cholesterol lowering will be discharged with a prescription for a statin if their physicians are contacted by a pharmacist to discuss treatment guidelines.
- Conditions
- Diabetes, Dyslipidemia
- Being tested
- Academic detailing
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic detailingOther
Education of physicians by pharmacists regarding indications for statins in diabetic patients
| Study group | Role | What they receive |
|---|---|---|
| Academic detailing of physicians | Experimental | Not described Receives: Other: Academic detailing |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin prescription at hospital discharge
Measured: Hospital discharge (avg = 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Thomas C Bailey, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113099
- Sponsor's protocol ID
- 02-1072
- Other IDs
- R01HL070790
- Status last verified
- Apr 2010
- First submitted
- 22 Apr 2010
- Last updated
- 29 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
McKinnon PS, Seaton T, Noirot LA, Reichley RM, Heard KM, Shannon WD, Goldberg AC, Dunagan WC, Bailey TC. Improving adherence to dyslipidemia medication guidelines in hospitalized diabetic patients using a technology-assisted pharmacist intervention. AMIA Annu Symp Proc. 2008 Nov 6:868.
PubMed 18999065Reichley R, McKinnon PS, Seaton T, Noirot L, Dunagan WC, Bailey TC. Adherence to dyslipidemia treatment guidelines in diabetic patients. AMIA Annu Symp Proc. 2006;2006:1071.
PubMed 17238690Reichley R, Rachmiel E, Seaton T, Noirot L, Longyhore D, Dunagan WC, Bailey TC. Intervention to improve dyslipidemia screening in hospitalized diabetics. AMIA Annu Symp Proc. 2005;2005:1093.
PubMed 16779380McKinnon PS, Reichley RM, Noirot LA, Dunagan WC, Bailey TC. Prospective validation of an algorithm to identify hospitalized diabetic patients using administrative data. AMIA Annu Symp Proc. 2006;2006:1029.
PubMed 17238648
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Detailing to Improve Guideline Adherence
- ClinicalTrials.gov ID
- NCT01113099
- Acronym / sponsor ID
- 02-1072
- Conditions
- Diabetes, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 29 Apr 2010 (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.
We hypothesize that when compared to usual care a greater proportion of hospitalized diabetic patients who are candidates for cholesterol lowering will be discharged with a prescription for a statin if their physicians are contacted by a pharmacist to discuss treatment guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Academic detailing of physicians | Experimental | Other: Academic detailing |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized patients with diabetes
- LDL >= 100
Key exclusion criteria (3 listed)
- Terminal illness
- Pregnancy
- Intolerance or contraindication to statin
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 |
|---|---|---|
| Academic detailingEducation of physicians by pharmacists regarding indications for statins in diabetic patients | Other | Academic detailing of physicians |
Primary outcome
Statin prescription at hospital discharge
Time frame: Hospital discharge (avg = 3 days)
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 29 Apr 2010.
- Results publication: PubMed 18999065McKinnon PS, Seaton T, Noirot LA, Reichley RM, Heard KM, Shannon WD, Goldberg AC, Dunagan WC, Bailey TC. Improving adherence to dyslipidemia medication guidelines in hospitalized diabetic patients using a technology-assisted pharmacist intervention. AMIA Annu Symp Proc. 2008 Nov 6:868.
- Results publication: PubMed 17238690Reichley R, McKinnon PS, Seaton T, Noirot L, Dunagan WC, Bailey TC. Adherence to dyslipidemia treatment guidelines in diabetic patients. AMIA Annu Symp Proc. 2006;2006:1071.
- Results publication: PubMed 16779380Reichley R, Rachmiel E, Seaton T, Noirot L, Longyhore D, Dunagan WC, Bailey TC. Intervention to improve dyslipidemia screening in hospitalized diabetics. AMIA Annu Symp Proc. 2005;2005:1093.
- Results publication: PubMed 17238648McKinnon PS, Reichley RM, Noirot LA, Dunagan WC, Bailey TC. Prospective validation of an algorithm to identify hospitalized diabetic patients using administrative data. AMIA Annu Symp Proc. 2006;2006:1029.
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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.
Thomas C Bailey, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Academic detailing in people with Diabetes and Dyslipidemia, run by Washington University School of Medicine 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 3 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 29 Apr 2010. 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?
Statin prescription at hospital discharge (time frame: Hospital discharge (avg = 3 days)). 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 NCT01113099, which also lists 4 linked publications.
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 29 Apr 2010.