Trial Outcomes & Findings for Web-Enhanced Guideline Implementation for Post MI CBOC Patients (NCT NCT00126750)

NCT ID: NCT00126750

Last Updated: 2015-07-23

Results Overview

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%).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

847 participants

Primary outcome timeframe

1/1/02 - 12/31/08

Results posted on

2015-07-23

Participant Flow

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)

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

Participant milestones

Participant milestones
Measure
Intervention Group
The intervention included a multicomponent Web site and pushed e-mail cues with educational content.
Control Group
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.
Overall Study
STARTED
385
462
Overall Study
COMPLETED
205
196
Overall Study
NOT COMPLETED
180
266

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Web-Enhanced Guideline Implementation for Post MI CBOC Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Arm/Group
n=385 Participants
Providers from eligible clinics that were allocated to the intervention arm.
Control Arm/Group
n=462 Participants
Providers from eligible clinics that were allocated to the control arm.
Total
n=847 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 (NUMBER)
n=5 Participants
0 (NUMBER)
n=7 Participants
0 (NUMBER)
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 (NUMBER)
n=5 Participants
0 (NUMBER)
n=7 Participants
0 (NUMBER)
n=5 Participants
Age, Categorical
>=65 years
0 (NUMBER)
n=5 Participants
0 (NUMBER)
n=7 Participants
0 (NUMBER)
n=5 Participants
Sex/Gender, Customized
Gender
0 (NUMBER)
n=5 Participants
0 (NUMBER)
n=7 Participants
0 (NUMBER)
n=5 Participants

PRIMARY outcome

Timeframe: 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%).

Outcome measures

Outcome measures
Measure
Intervention
n=385 Participants
Intervention Providers received an interactive, educational website and motivational reminders.
Control
n=462 Participants
Control Providers received a link to VA practice guidelines.
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
2.1 percentage of provider's patients
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
9.5 percentage of provider's patients
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
12.1 percentage of provider's patients
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
7.5 percentage of provider's patients
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
2.9 percentage of provider's patients
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
15.2 percentage of provider's patients
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
.7 percentage of provider's patients

Adverse Events

Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Houston II

VA Bedford CHOIR

Phone: 781-687-2884

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place