Comorbidity, Myocardial Infarction
Conditions
Keywords
Myocardial Infarction, Comorbidities, Guidelines, Computer Assisted Instruction, Physician Practice Instruction, Online Systems
Brief summary
To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in managing complex patients by providing a single, interactive, and personalized source of information regarding applicable guidelines for post-MI patients. Specifically, 1) the investigators will identify barriers to provider adherence to guidelines within VHA clinics; 2) Apply guideline-based performance measures to electronic medical records (CPRS) and associated administrative data; 3) Implement the interactive Internet intervention developed by the NHLBI study, after inclusion of VA-specific components, including performance feedback for CBOC clinicians; and 4) Test hypotheses on the intervention's effectiveness, sustainability, and cost-effectiveness in both the VA and Medicare populations. This will include a randomized controlled trial with the CBOC as a unit of randomization.
Detailed description
Some 7.1 million Americans and an estimated 250,000 Veterans actively using VHA are Myocardial Infarction (MI) survivors. To date, most guideline interventions focus on a single patient condition, but ambulatory post-MI patients are frequently more complex, multiple comorbidities, and conflicting guidelines applicable to them. For example, whereas JNC-6 guidelines for the treatment of hypertension suggest pharmacological treatment at blood pressures above 140/80 mm Hg, to be initiated with diuretics or beta-blockers as first line agents, other guidance suggests that for post-MI patients with diabetes, treatment cut-offs should be lower and ACE-inhibitors may be considered as optimal first-line agents. On October 1, 2002, the University of Alabama at Birmingham (UAB) began a study funded by the National Heart, Lung, and Blood institute (NHLBI) as an RO1 (Kiefe, PI (25%), Weissman, co-PI (20%)) to conduct a randomized trial, MI-plus to increase provider adherence to guidelines for post-MI patients. That NHLBI-funded study targets Medicare beneficiaries and their primary care providers in Alabama. Its primary goal is to develop and test with a randomized controlled trial, an Internet-based multimodal guideline implementation strategy. The investigators propose, herewith, to extend and adapt this study to a nationwide sample of VA post-MI patients and their primary care providers in the VA.
Interventions
BEHAVIORALVA MI Plus Interactive
The experimental intervention, customized to the individual clinician in real-time consists of Internet learning modules integrating case-based education with audit, feedback, and benchmarking of practice profiles.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Potential subjects are defined as any VA-employed physician, PA, or CRNP who is a CBOC provider. All such providers will be offered the opportunity to participate and will have the option to agree to participate or not. Performance measure data from records of post-MI patients of the above providers will be extracted to test the experimental intervention. (Note: No individually identifying patient information will be extracted.) All VA-employed CBOC providers (physicians, PAs, CRNPs) will be offered the opportunity to participate in this study. Any subject may refuse to participate or to discontinue participation at will at any point in the study without consequence.
Exclusion criteria
Potential subjects must be VA-employed physician, PA, or CRNP who is a CBOC provider. No such healthcare providers will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | 1/1/02 - 12/31/08 | The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level \< previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level \< previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (\<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (\<8%). |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Among 66 eligible medical centers, the investigators recruited 48 affiliated with 219 clinics, including 957 providers in 26 states, the VIrgin Islands, and Puerto Rico; of these, 168 clinics were randomized (ie, had \>1 provider enroll)
Pre-assignment details
Clinics were randomized when first eligible provider at that clinic logged on to the Web site.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm/Group Providers from eligible clinics that were allocated to the intervention arm. | 385 |
| Control Arm/Group Providers from eligible clinics that were allocated to the control arm. | 462 |
| Total | 847 |
Baseline characteristics
| Characteristic | Intervention Arm/Group | Control Arm/Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 | 0 | 0 |
| Age, Categorical >=65 years | 0 | 0 | 0 |
| Age, Categorical Between 18 and 65 years | 0 | 0 | 0 |
| Sex/Gender, Customized Gender | 0 | 0 | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators
The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level \< previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level \< previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (\<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (\<8%).
Time frame: 1/1/02 - 12/31/08
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients prescribed B-Blockers | 15.5 percentage of provider's patients |
| Intervention | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients prescribed ACEI or ARB | 4.9 percentage of provider's patients |
| Intervention | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients w/ improvement in HbA1c | 11.5 percentage of provider's patients |
| Intervention | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients reaching target LDL | 19.9 percentage of provider's patients |
| Intervention | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % patients prescribed Statins | 8.5 percentage of provider's patients |
| Intervention | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients reaching target HbA1c | 6 percentage of provider's patients |
| Intervention | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients w/ improvement in LDL | 2.8 percentage of provider's patients |
| Control | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients reaching target HbA1c | .7 percentage of provider's patients |
| Control | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients w/ improvement in LDL | 2.1 percentage of provider's patients |
| Control | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients w/ improvement in HbA1c | 9.5 percentage of provider's patients |
| Control | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients prescribed B-Blockers | 12.1 percentage of provider's patients |
| Control | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % patients prescribed Statins | 7.5 percentage of provider's patients |
| Control | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients prescribed ACEI or ARB | 2.9 percentage of provider's patients |
| Control | Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators | Change in % of patients reaching target LDL | 15.2 percentage of provider's patients |