Trial Outcomes & Findings for Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study) (NCT NCT00632021)
NCT ID: NCT00632021
Last Updated: 2017-09-01
Results Overview
Number of clinically important medication errors per patient
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
862 participants
Primary outcome timeframe
Measured at Day 30
Results posted on
2017-09-01
Participant Flow
Adults admitted to Vanderbilt University Hospital or Brigham and Women's Hospital for acute coronary syndromes or acute decompensated heart failure were enrolled between May 2008 and September 2009. We enrolled and randomized 862 patients. Eleven patients withdrew consent or died in the hospital, leaving 851 patients in the analysis.
This was a randomized, controlled trial with concealed allocation and blinded outcome assessors. We enrolled and randomized 862 patients (430 intervention and 432 usual care). Eleven patients (7 intervention and 4 usual care) withdrew consent or died in the hospital, leaving 851 patients in the intention-to-treat analysis.
Participant milestones
| Measure |
Control (Usual Care)
Control (usual care) arm
|
Intervention
Intervention arm
|
|---|---|---|
|
Overall Study
STARTED
|
432
|
430
|
|
Overall Study
COMPLETED
|
428
|
423
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Control (Usual Care)
Control (usual care) arm
|
Intervention
Intervention arm
|
|---|---|---|
|
Overall Study
Withdrawal/death
|
4
|
7
|
Baseline Characteristics
Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study)
Baseline characteristics by cohort
| Measure |
Control (Usual Care)
n=428 Participants
Control (usual care) arm
|
Intervention
n=423 Participants
Intervention arm
|
Total
n=851 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 14 • n=5 Participants
|
61 years
STANDARD_DEVIATION 14 • n=7 Participants
|
60 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
249 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
499 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
335 Participants
n=5 Participants
|
319 Participants
n=7 Participants
|
654 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
428 Number of participants
n=5 Participants
|
423 Number of participants
n=7 Participants
|
851 Number of participants
n=5 Participants
|
|
Study Site
Vanderbilt University Hospital
|
200 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Study Site
Brigham and Women's Hospital
|
228 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Health literacy (sTOFHLA score)
Inadequate
|
39 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Health literacy (sTOFHLA score)
Marginal
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Health literacy (sTOFHLA score)
Adequate
|
340 Participants
n=5 Participants
|
331 Participants
n=7 Participants
|
671 Participants
n=5 Participants
|
|
Health literacy (sTOFHLA score)
Missing
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Language
English
|
425 Participants
n=5 Participants
|
414 Participants
n=7 Participants
|
839 Participants
n=5 Participants
|
|
Language
Spanish
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
|
14 years
n=5 Participants
|
14 years
n=7 Participants
|
14 years
n=5 Participants
|
|
Income
<10K
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Income
10K to <15K
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Income
15K to <20K
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Income
20K to <25K
|
47 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Income
25K to <35K
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Income
35K to <50K
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Income
50K to <75K
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Income
75K+
|
119 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Income
Missing
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Cognition (Mini cog score)
Impaired
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Cognition (Mini cog score)
Not impaired
|
380 Participants
n=5 Participants
|
371 Participants
n=7 Participants
|
751 Participants
n=5 Participants
|
|
Cognition (Mini cog score)
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Has primary care provider
Yes
|
392 Participants
n=5 Participants
|
386 Participants
n=7 Participants
|
778 Participants
n=5 Participants
|
|
Has primary care provider
No
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Number of pre-admission medications
|
7 Medications
n=5 Participants
|
8 Medications
n=7 Participants
|
8 Medications
n=5 Participants
|
|
Comorbidities
Diabetes
|
195 participants
n=5 Participants
|
140 participants
n=7 Participants
|
335 participants
n=5 Participants
|
|
Comorbidities
Hypertension
|
296 participants
n=5 Participants
|
306 participants
n=7 Participants
|
602 participants
n=5 Participants
|
|
Comorbidities
Hypercholesterolemia
|
236 participants
n=5 Participants
|
234 participants
n=7 Participants
|
470 participants
n=5 Participants
|
|
Comorbidities
Coronary artery disease
|
211 participants
n=5 Participants
|
225 participants
n=7 Participants
|
436 participants
n=5 Participants
|
|
Comorbidities
Prior myocardial infarction
|
73 participants
n=5 Participants
|
100 participants
n=7 Participants
|
173 participants
n=5 Participants
|
|
Comorbidities
Prior stroke or cerebrovascular event
|
41 participants
n=5 Participants
|
30 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Comorbidities
Prior coronary revascularization procedure
|
195 participants
n=5 Participants
|
203 participants
n=7 Participants
|
398 participants
n=5 Participants
|
|
Marital status
Married/cohabitating
|
256 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
482 Participants
n=5 Participants
|
|
Marital status
Single/living alone
|
172 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
|
Insurance status
Medicare
|
162 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
|
Insurance status
Medicaid
|
37 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Insurance status
Commercial
|
203 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
370 Participants
n=5 Participants
|
|
Insurance status
Self-pay/other
|
26 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 30Number of clinically important medication errors per patient
Outcome measures
| Measure |
Control
n=428 Participants
Control (usual care) arm
|
Intervention
n=423 Participants
Intervention arm
|
|---|---|---|
|
Number of Serious Medication Errors as Determined by Interview and Medical Chart Review
|
0.95 serious medication errors
Standard Deviation 1.36
|
0.87 serious medication errors
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Measured at Day 30Unplanned hospitalizations and Emergency Department visits
Outcome measures
| Measure |
Control
n=428 Participants
Control (usual care) arm
|
Intervention
n=423 Participants
Intervention arm
|
|---|---|---|
|
Number of Participants With Unplanned Hospitalizations and Emergency Department Visits
Hospital readmission
|
66 Participants
|
61 Participants
|
|
Number of Participants With Unplanned Hospitalizations and Emergency Department Visits
No readmission
|
362 Participants
|
362 Participants
|
Adverse Events
Control (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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
Research Coordinator
Vanderbilt University Medical Center
Phone: 6159364819
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place