Diabetes MellitusNCT00262197
Patient Based Strategy to Reduce Errors in Diabetes Care
A study testing Customized Physician Intervention and Customized Patient Intervention in people with Diabetes Mellitus, run by HealthPartners Institute.
Trial summary
This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Customized Physician Intervention and Customized Patient Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Aug 2005
- 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
- For physician intervention inclusion criteria included; 1)primary care (general internist or family) physician in HealthPartners Medical Group. 2)Provided ongoing care to 20 or more adult patients with diabetes.
- For patients inclusion criteria included; An established diagnosis of diabetes based on either (a) two or more ICD-9 diagnosis codes for diabetes in a 12-month period of time, or (b) a filled prescription for a diabetes-specific drug within a 12-month period of time.
- In addition, participating patients met all of the following criteria: (a) age less than 75 years, (b) Charlson comorbidity score of 3 or less, (c) linked to the a primary care physician who was participating in the study in two consecutive calendar years, (d) had pharmacy coverage at the time of the intervention and for the previous 12-month period, and (e) had either HBA1c > 7% or LDL > 130 mg/dl (or LDL > 100 mg/dl if the patient also had CHD).
Who cannot join
- none
About this study
This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.
Read the detailed description
The project, Patient-Based Strategy to Reduce Errors in Diabetes Care (referred to as MOVES), addresses issues of overuse, under use, or misuse of care for adults with diabetes. This combination research and translation project has been developed as a component of the Pursuing Perfection initiative of HealthPartners Medical Group, with the close collaboration of HPMG leadership. HealthPartners Medical Group is widely regarded as a national leader in diabetes care, with dramatic improvements in both glucose control and cholesterol control over the past 8 years [Graphs].
The MOVES study is attempting to activate patients with diabetes to be more involved in their care. To help patients do this, HPMG sends patients a customized summary of their care. The summary includes a graph of recent glucose and cholesterol test results and specific suggestions that may improve care. In many cases, a visit with the patient's personal physician is encouraged to assure ongoing progress towards important evidence-based goals in diabetes care.
Physicians also receive a matched communication that indicates areas for potential improvement and makes technical suggestions for care based on the Staged Diabetes Management © protocols. The project tries to ally expert judgment with the physician's personal knowledge of a patient. It is felt that this approach is critical to assessing what the best improvement strategy may be in each individual case.
This inexpensive customized intervention has potential to be widely disseminated and can be seamlessly integrated with other interventions to further achievement of clinical goals. The results are relevant to patients, clinicians, payers, and policymakers.
- Conditions
- Diabetes Mellitus
- Being tested
- Customized Physician Intervention, Customized Patient Intervention
- Keywords
- Diabetes mellitus, Medical error rates, Pharmacotherapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized Physician InterventionBehavioural
Customized Patient InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The following dependant variables were measured in this study;
Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and
LDL-cholesterol levels and test rates in the 12 months post-intervention.
Secondary outcomes (3)
Age
Gender
Charlson comorbidity score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startDec 2001
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 10,000 participants
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Patrick J O'Connor, MD, MPH, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262197
- Sponsor's protocol ID
- 0105300
- Other IDs
- U18HS011919
- Status last verified
- Sep 2012
- First submitted
- 5 Dec 2005
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sperl-Hillen JM, O'Connor PJ. Factors driving diabetes care improvement in a large medical group: ten years of progress. Am J Manag Care. 2005 Aug;11(5 Suppl):S177-85.
PubMed 16111440O'Connor PJ, Gray RJ, Maciosek MV, Fillbrandt KM, DeFor TA, Alexander CM, Weiss TW, Teutsch SM. Cholesterol levels and statin use in patients with coronary heart disease treated in primary care settings. Prev Chronic Dis. 2005 Jul;2(3):A05. Epub 2005 Jun 15.
PubMed 15963307Gilmer TP, O'Connor PJ, Rush WA, Crain AL, Whitebird RR, Hanson AM, Solberg LI. Predictors of health care costs in adults with diabetes. Diabetes Care. 2005 Jan;28(1):59-64. doi: 10.2337/diacare.28.1.59.
PubMed 15616234O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Biltz G. Clinical Inertia and Outpatient Medical Errors. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20513/
PubMed 21249838O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA. Identification, Classification, and Frequency of Medical Errors in Outpatient Diabetes Care. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20464/
PubMed 21249801O'Connor PJ, Sperl-Hillen J, Johnson PE, Rush WA, Crain AL. Customized feedback to patients and providers failed to improve safety or quality of diabetes care: a randomized trial. Diabetes Care. 2009 Jul;32(7):1158-63. doi: 10.2337/dc08-2247. Epub 2009 Apr 14.
PubMed 19366977
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Based Strategy to Reduce Errors in Diabetes Care
- ClinicalTrials.gov ID
- NCT00262197
- Acronym / sponsor ID
- 0105300
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Medical error rates, Pharmacotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2001
- Study completion
- Aug 2005 (actual)
- First posted
- 6 Dec 2005 (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 evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.
Detailed description
The project, Patient-Based Strategy to Reduce Errors in Diabetes Care (referred to as MOVES), addresses issues of overuse, under use, or misuse of care for adults with diabetes. This combination research and translation project has been developed as a component of the Pursuing Perfection initiative of HealthPartners Medical Group, with the close collaboration of HPMG leadership. HealthPartners Medical Group is widely regarded as a national leader in diabetes care, with dramatic improvements in both glucose control and cholesterol control over the past 8 years [Graphs].
The MOVES study is attempting to activate patients with diabetes to be more involved in their care. To help patients do this, HPMG sends patients a customized summary of their care. The summary includes a graph of recent glucose and cholesterol test results and specific suggestions that may improve care. In many cases, a visit with the patient's personal physician is encouraged to assure ongoing progress towards important evidence-based goals in diabetes care.
Physicians also receive a matched communication that indicates areas for potential improvement and makes technical suggestions for care based on the Staged Diabetes Management © protocols. The project tries to ally expert judgment with the physician's personal knowledge of a patient. It is felt that this approach is critical to assessing what the best improvement strategy may be in each individual case.
This inexpensive customized intervention has potential to be widely disseminated and can be seamlessly integrated with other interventions to further achievement of clinical goals. The results are relevant to patients, clinicians, payers, and policymakers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For physician intervention inclusion criteria included; 1)primary care (general internist or family) physician in HealthPartners Medical Group. 2)Provided ongoing care to 20 or more adult patients with diabetes.
- For patients inclusion criteria included; An established diagnosis of diabetes based on either (a) two or more ICD-9 diagnosis codes for diabetes in a 12-month period of time, or (b) a filled prescription for a diabetes-specific drug within a 12-month period of time.
- In addition, participating patients met all of the following criteria: (a) age less than 75 years, (b) Charlson comorbidity score of 3 or less, (c) linked to the a primary care physician who was participating in the study in two consecutive calendar years, (d) had pharmacy coverage at the time of the intervention and for the previous 12-month period, and (e) had either HBA1c > 7% or LDL > 130 mg/dl (or LDL > 100 mg/dl if the patient also had CHD).
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Customized Physician Intervention | Behavioural | – |
| Customized Patient Intervention | Behavioural | – |
Primary outcome
The following dependant variables were measured in this study;
Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and
LDL-cholesterol levels and test rates in the 12 months post-intervention.
3 secondary outcomes
Age
Gender
Charlson comorbidity score
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 5 Sep 2012.
- Background: PubMed 16111440Sperl-Hillen JM, O'Connor PJ. Factors driving diabetes care improvement in a large medical group: ten years of progress. Am J Manag Care. 2005 Aug;11(5 Suppl):S177-85.
- Background: PubMed 15963307O'Connor PJ, Gray RJ, Maciosek MV, Fillbrandt KM, DeFor TA, Alexander CM, Weiss TW, Teutsch SM. Cholesterol levels and statin use in patients with coronary heart disease treated in primary care settings. Prev Chronic Dis. 2005 Jul;2(3):A05. Epub 2005 Jun 15.
- Background: PubMed 15616234Gilmer TP, O'Connor PJ, Rush WA, Crain AL, Whitebird RR, Hanson AM, Solberg LI. Predictors of health care costs in adults with diabetes. Diabetes Care. 2005 Jan;28(1):59-64. doi: 10.2337/diacare.28.1.59.
- Background: PubMed 21249838O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Biltz G. Clinical Inertia and Outpatient Medical Errors. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20513/
- Background: PubMed 21249801O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA. Identification, Classification, and Frequency of Medical Errors in Outpatient Diabetes Care. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20464/
- Derived from this study: PubMed 19366977O'Connor PJ, Sperl-Hillen J, Johnson PE, Rush WA, Crain AL. Customized feedback to patients and providers failed to improve safety or quality of diabetes care: a randomized trial. Diabetes Care. 2009 Jul;32(7):1158-63. doi: 10.2337/dc08-2247. Epub 2009 Apr 14.
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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.
Patrick J O'Connor, MD, MPH principal investigator
HealthPartners Institute
Questions about this trial
What is this clinical trial studying?
A study testing Customized Physician Intervention and Customized Patient Intervention in people with Diabetes Mellitus, run by HealthPartners Institute.
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 1 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 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The following dependant variables were measured in this study;. 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 NCT00262197, which also lists 6 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 5 Sep 2012.