DiabetesNCT00503464
"Assessing Barriers to ADA Guideline Adherence"
An observational study of Diabetes, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
This project involves a comprehensive assessment of barriers to diabetes guidelines adherence across 25 practices in the Crozer-Keystone primary care PBRN. A Barrier Assessment Tool (BAT) will be validated to correlate with provider and practice adherence to diabetes care guidelines. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to not given
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Crozer-Keystone Health Network primary care (Internal Medicine and Family Medicine) providers and support staff in the 25 primary care practices.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Crozer-Keystone Health System Practice-Based Research Network
Upland, Pennsylvania, 19013
Anne M. Allie, B.S., 610-579-3491, annemarie.allie@crozer.org
Mitchell A. Kaminski, M.D., M.B.A.
About this study
Official title: "Assessing Barriers to American Diabetes Association Guideline Adherence"
This project involves a comprehensive assessment of barriers to diabetes guidelines adherence across 25 practices in the Crozer-Keystone primary care PBRN. A Barrier Assessment Tool (BAT) will be validated to correlate with provider and practice adherence to diabetes care guidelines. The network is part of the Crozer-Keystone Health System located in Delaware County, Pennsylvania, in the southeast quadrant of the Philadelphia metropolitan region.
Read the detailed description
Study hypothesis: Questionnaire responses about perceived barriers to implementation of diabetes care recommendations, administered to primary care providers and staff, will be shown to correlate with that provider's and practice's success at implementing care guidelines.
Diabetes care in the U.S. consistently fails to meet recommended quality standards. Barriers impede the translation of evidence-based guidelines into sustainable practice. Few studies have considered multiple barriers, and there is a lack of evidence-based strategy in choosing interventions to overcome barriers. This study involves a comprehensive assessment of practice barriers to diabetes guidelines adherence across a primary care network. The BAT based upon a framework proposed by Cabana, et al (1999) will be validated to correlate with provider and practice adherence to diabetes care guidelines. A Diabetes Flow Sheet implemented in our Network to track adherence to guidelines will be assessed and correlated with measured barriers. This organizational strategy will support an evidence-based approach to quality initiative interventions. The BAT will be administered to practice team members: providers, support staff, and practice managers in our Network of 25 primary care practices. Five hypotheses are tested:
A: The BAT measures perceived barriers to adherence to diabetes guidelines, while showing adequate internal consistency and an identifiable subscale structure.
B: The BAT results inversely correlate with practice and provider adherence to ADA guidelines.
C: BAT scores will inversely correlate with use of the Diabetes Flow Sheet.
D: The BAT scores inversely correlate with clinical outcomes (glycemic and lipid control.)
E: Use of the Diabetes Flow Sheet correlates with higher provider and practice adherence to ADA guidelines.
The BAT would then provide the structure for comprehensive assessment of barriers. Study of the Crozer-Keystone PBRN is a real-world laboratory for research in the translation of evidence into diverse practices. The Network is optimally positioned to implement and study this organizational strategy.
- Conditions
- Diabetes
- Keywords
- guideline, adherence
- Medical subject headings
- Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Investigators
- Mitchell A. Kaminski, M.D., M.B.A., Principal investigator, Crozer-Keystone Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503464
- Sponsor's protocol ID
- #R03 HS016065-01
- Other IDs
- PAR-04-041
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2007
- Last updated
- 19 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Assessing Barriers to American Diabetes Association Guideline Adherence"
- ClinicalTrials.gov ID
- NCT00503464
- Acronym / sponsor ID
- #R03 HS016065-01
- Conditions
- Diabetes
- Keywords
- guideline, adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Sep 2006
- First posted
- 18 Jul 2007 (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.
This project involves a comprehensive assessment of barriers to diabetes guidelines adherence across 25 practices in the Crozer-Keystone primary care PBRN. A Barrier Assessment Tool (BAT) will be validated to correlate with provider and practice adherence to diabetes care guidelines. The network is part of the Crozer-Keystone Health System located in Delaware County, Pennsylvania, in the southeast quadrant of the Philadelphia metropolitan region.
Detailed description
Study hypothesis: Questionnaire responses about perceived barriers to implementation of diabetes care recommendations, administered to primary care providers and staff, will be shown to correlate with that provider's and practice's success at implementing care guidelines.
Diabetes care in the U.S. consistently fails to meet recommended quality standards. Barriers impede the translation of evidence-based guidelines into sustainable practice. Few studies have considered multiple barriers, and there is a lack of evidence-based strategy in choosing interventions to overcome barriers. This study involves a comprehensive assessment of practice barriers to diabetes guidelines adherence across a primary care network. The BAT based upon a framework proposed by Cabana, et al (1999) will be validated to correlate with provider and practice adherence to diabetes care guidelines. A Diabetes Flow Sheet implemented in our Network to track adherence to guidelines will be assessed and correlated with measured barriers. This organizational strategy will support an evidence-based approach to quality initiative interventions. The BAT will be administered to practice team members: providers, support staff, and practice managers in our Network of 25 primary care practices. Five hypotheses are tested:
A: The BAT measures perceived barriers to adherence to diabetes guidelines, while showing adequate internal consistency and an identifiable subscale structure.
B: The BAT results inversely correlate with practice and provider adherence to ADA guidelines.
C: BAT scores will inversely correlate with use of the Diabetes Flow Sheet.
D: The BAT scores inversely correlate with clinical outcomes (glycemic and lipid control.)
E: Use of the Diabetes Flow Sheet correlates with higher provider and practice adherence to ADA guidelines.
The BAT would then provide the structure for comprehensive assessment of barriers. Study of the Crozer-Keystone PBRN is a real-world laboratory for research in the translation of evidence into diverse practices. The Network is optimally positioned to implement and study this organizational strategy.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Crozer-Keystone Health Network primary care (Internal Medicine and Family Medicine) providers and support staff in the 25 primary care practices.
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.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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.
Mitchell A. Kaminski, M.D., M.B.A. principal investigator
Crozer-Keystone Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Agency for Healthcare Research and Quality (AHRQ) 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 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: status not confirmed, as of the sponsor's last update on 19 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne M Allie, B.S. (610-579-3491, annemarie.allie@crozer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Jul 2012.