VA MI Plus: Web-Enhanced Guideline Implementation for Post MI CBOC Patients

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00126750
• Collaborator: (none)
• Enrollment: 847
• Locations: 41
• Arm: 1
• Duration (Months): 81
• Patients Per Site: 20.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Comorbidity	Behavioral: VA MI Plus Interactive	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 847 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1	Behavioral: VA 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.

Outcome Measures

Primary Outcome Measures

1. 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%).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Birmingham	Birmingham	Alabama	United States	35233
2	Carl T. Hayden VA Medical Center	Phoenix	Arizona	United States	85012
3	Fayetteville, AR	Fayetteville	Arkansas	United States	72703
4	Long Beach	Long Beach	California	United States	90822
5	VA Medical Center	San Francisco	California	United States	94121
6	VA Connecticut Health Care System (West Haven)	West Haven	Connecticut	United States	06516
7	Bay Pines VA Healthcare System, Pay Pines, FL	Bay Pines	Florida	United States	33708
8	VA Medical Center, Miami	Miami	Florida	United States	33125
9	VA Medical Center, Decatur	Decatur	Georgia	United States	30033
10	Jesse Brown VAMC (WestSide Division)	Chicago	Illinois	United States	60612
11	VA Illiana Health Care System	Danville	Illinois	United States	61832
12	VA Medical Center Iowa City	Iowa City	Iowa	United States	52246
13	VA Eastern Kansas Health Care System - Topeka	Topeka	Kansas	United States	66622
14	Robert J. Dole VAMC & ROC	Wichita	Kansas	United States	67218
15	VA Medical Center, Louisville	Louisville	Kentucky	United States	40206
16	Overton Brooks VA Medical Center, Shreveport, LA	Shreveport	Louisiana	United States	71101
17	Edith Nourse Rogers Memorial Veterans Hospital	Bedford	Massachusetts	United States	01730
18	VA Boston Health Care System, Jamaica Plain	Boston	Massachusetts	United States	02130
19	VA Ann Arbor Healthcare System	Ann Arbor	Michigan	United States	48105
20	Battle Creek, MI	Battle Creek	Michigan	United States	49015
21	VA Gulf Coast Veterans Health Care System	Biloxi	Mississippi	United States	39531
22	Harry S. Truman Memorial VA Medical Center	Columbia	Missouri	United States	65201-5297
23	Kansas City VA Medical Center	Kansas City	Missouri	United States	64128
24	VA Medical Center, St Louis	St Louis	Missouri	United States	63106
25	VA New Jersey Health Care System, East Orange	East Orange	New Jersey	United States	07018
26	Albany VA Medical Center: Samuel S. Stratton	Albany	New York	United States	12208
27	No Longer Valid, Use 528A8	Albany	New York	United States	12208
28	Franklin Delano Roosevelt Campus of VAHVHCS	Montrose	New York	United States	10548
29	New York, NY	New York	New York	United States	10010
30	VA Medical Center, Cincinnati	Cincinnati	Ohio	United States	45220
31	VA Medical Center, Cleveland	Cleveland	Ohio	United States	44106-3800
32	Coatesville, PA	Coatesville	Pennsylvania	United States	19320
33	Lebanon, PA	Lebanon	Pennsylvania	United States	17042
34	VA Medical Center, Providence	Providence	Rhode Island	United States	02908-4799
35	Ralph H Johnson VA Medical Center, Charleston	Charleston	South Carolina	United States	29401-5799
36	VA Medical Center	Nashville	Tennessee	United States	37212-2637
37	VA Salt Lake City Health Care System, Salt Lake City	Salt Lake City	Utah	United States	84148
38	VA Medical & Regional Office Center, White River	White River Junction	Vermont	United States	05009-0001
39	William S. Middleton Memorial Veterans Hospital	Madison	Wisconsin	United States	53705
40	Clement J. Zablocki VAMC	Milwaukee	Wisconsin	United States	53295-1000
41	San Juan VAMC	San Juan		Puerto Rico	00921-3201

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Thomas K Houston, MD MPH, Edith Nourse Rogers Memorial Veterans Hospital, Bedford
• Principal Investigator: Ellen Funkhouser, DrPH MS BS, VA Medical Center, Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00126750
• Other Study ID Numbers: SDR 03-090
• First Posted: Aug 4, 2005
• Last Update Posted: Jul 23, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by US Department of Veterans Affairs: Myocardial Infarction; Comorbidities; Guidelines; Computer Assisted Instruction; Physician Practice Instruction; Online Systems
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

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 Detail	Clinics were randomized when first eligible provider at that clinic logged on to the Web site.

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	The intervention included a multicomponent Web site and pushed e-mail cues with educational content.	Providers in control clinics were sent a link to an existing VA Web site that contained links to a wide range of clinical guidelines for various medical conditions.
Period Title: Overall Study
STARTED	385	462
COMPLETED	205	196
NOT COMPLETED	180	266

Baseline Characteristics

Arm/Group Title	Intervention Arm/Group	Control Arm/Group	Total
Arm/Group Description	Providers from eligible clinics that were allocated to the intervention arm.	Providers from eligible clinics that were allocated to the control arm.	Total of all reporting groups
Overall Participants	385	462	847
Age () [Number]
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Sex/Gender, Customized () [Number]
Gender	0	0	0

Outcome Measures

1. Primary Outcome

Title	Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Intervention Providers received an interactive, educational website and motivational reminders.	Control Providers received a link to VA practice guidelines.
Measure Participants	385	462
Change in % of patients w/ improvement in LDL	2.8	2.1
Change in % of patients w/ improvement in HbA1c	11.5	9.5
Change in % of patients prescribed B-Blockers	15.5	12.1
Change in % patients prescribed Statins	8.5	7.5
Change in % of patients prescribed ACEI or ARB	4.9	2.9
Change in % of patients reaching target LDL	19.9	15.2
Change in % of patients reaching target HbA1c	6	.7

Adverse Events

Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.		Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.