Trial Outcomes & Findings for Multi-arm Intervention Diabetes Adherence Study (NCT NCT00754741)
NCT ID: NCT00754741
Last Updated: 2015-05-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1692 participants
Primary outcome timeframe
at 18 months post randomization
Results posted on
2015-05-08
Participant Flow
Participant milestones
| Measure |
Usual Care
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Overall Study
STARTED
|
567
|
569
|
556
|
|
Overall Study
COMPLETED
|
510
|
500
|
502
|
|
Overall Study
NOT COMPLETED
|
57
|
69
|
54
|
Reasons for withdrawal
| Measure |
Usual Care
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Overall Study
Died or disenrolled
|
57
|
69
|
54
|
Baseline Characteristics
Multi-arm Intervention Diabetes Adherence Study
Baseline characteristics by cohort
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
Total
n=1692 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
63.3 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
64.5 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
64.3 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
302 Participants
n=99 Participants
|
270 Participants
n=107 Participants
|
266 Participants
n=206 Participants
|
838 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
265 Participants
n=99 Participants
|
299 Participants
n=107 Participants
|
290 Participants
n=206 Participants
|
854 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
224 Participants
n=99 Participants
|
237 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
699 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
297 Participants
n=99 Participants
|
294 Participants
n=107 Participants
|
281 Participants
n=206 Participants
|
872 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
46 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
HbA1c
|
8.0 %
STANDARD_DEVIATION 1.4 • n=99 Participants
|
8.2 %
STANDARD_DEVIATION 1.4 • n=107 Participants
|
8.0 %
STANDARD_DEVIATION 1.3 • n=206 Participants
|
8.0 %
STANDARD_DEVIATION 1.4 • n=7 Participants
|
|
LDL-C
|
99.9 mg/dL
STANDARD_DEVIATION 31.4 • n=99 Participants
|
98.5 mg/dL
STANDARD_DEVIATION 33.8 • n=107 Participants
|
97.1 mg/dL
STANDARD_DEVIATION 31.5 • n=206 Participants
|
98.5 mg/dL
STANDARD_DEVIATION 32.2 • n=7 Participants
|
|
Serum creatinine
|
1.1 mg/dL
STANDARD_DEVIATION 0.4 • n=99 Participants
|
1.1 mg/dL
STANDARD_DEVIATION 0.3 • n=107 Participants
|
1.2 mg/dL
STANDARD_DEVIATION 0.9 • n=206 Participants
|
1.1 mg/dL
STANDARD_DEVIATION 0.6 • n=7 Participants
|
|
Systolic blood pressure
|
133.6 mmHg
STANDARD_DEVIATION 15.4 • n=99 Participants
|
132.3 mmHg
STANDARD_DEVIATION 15.3 • n=107 Participants
|
133.2 mmHg
STANDARD_DEVIATION 15.8 • n=206 Participants
|
133.0 mmHg
STANDARD_DEVIATION 15.5 • n=7 Participants
|
|
Diastolic blood pressure
|
74.8 mmHg
STANDARD_DEVIATION 10.0 • n=99 Participants
|
75.6 mmHg
STANDARD_DEVIATION 9.3 • n=107 Participants
|
75.0 mmHg
STANDARD_DEVIATION 9.2 • n=206 Participants
|
75.1 mmHg
STANDARD_DEVIATION 9.5 • n=7 Participants
|
|
Insulin use
|
187 participants
n=99 Participants
|
191 participants
n=107 Participants
|
192 participants
n=206 Participants
|
570 participants
n=7 Participants
|
|
Biguanide use
|
335 participants
n=99 Participants
|
364 participants
n=107 Participants
|
347 participants
n=206 Participants
|
1046 participants
n=7 Participants
|
|
Thiazolidinedione use
|
78 participants
n=99 Participants
|
85 participants
n=107 Participants
|
73 participants
n=206 Participants
|
236 participants
n=7 Participants
|
|
Sulfonylurea use
|
327 participants
n=99 Participants
|
341 participants
n=107 Participants
|
337 participants
n=206 Participants
|
1005 participants
n=7 Participants
|
|
Alpha-glucosidase inhibitor use
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
Meglitinide use
|
8 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
13 participants
n=7 Participants
|
|
Statin use
|
446 participants
n=99 Participants
|
452 participants
n=107 Participants
|
443 participants
n=206 Participants
|
1341 participants
n=7 Participants
|
|
Ezetimibe use
|
73 participants
n=99 Participants
|
77 participants
n=107 Participants
|
90 participants
n=206 Participants
|
240 participants
n=7 Participants
|
|
Fibrate use
|
59 participants
n=99 Participants
|
51 participants
n=107 Participants
|
50 participants
n=206 Participants
|
160 participants
n=7 Participants
|
|
Niacin use
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Bile acid sequestrant use
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Oral diabetes medication adherence
|
0.76 Adherence - proportion
STANDARD_DEVIATION 0.35 • n=99 Participants
|
0.76 Adherence - proportion
STANDARD_DEVIATION 0.35 • n=107 Participants
|
0.75 Adherence - proportion
STANDARD_DEVIATION 0.36 • n=206 Participants
|
0.75 Adherence - proportion
STANDARD_DEVIATION 0.36 • n=7 Participants
|
|
Lipid-lowering medication adherence
|
0.71 Adherence - proportion
STANDARD_DEVIATION 0.37 • n=99 Participants
|
0.70 Adherence - proportion
STANDARD_DEVIATION 0.37 • n=107 Participants
|
0.69 Adherence - proportion
STANDARD_DEVIATION 0.37 • n=206 Participants
|
0.70 Adherence - proportion
STANDARD_DEVIATION 0.37 • n=7 Participants
|
PRIMARY outcome
Timeframe: at 18 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Glycated Hemoglobin Levels
|
7.88 Percent
Standard Deviation 1.53
|
7.91 Percent
Standard Deviation 1.53
|
7.79 Percent
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: at 18 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
LDL-cholesterol Levels
|
89.02 mg/dL
Standard Deviation 32.11
|
87.27 mg/dL
Standard Deviation 35.67
|
85.56 mg/dL
Standard Deviation 32.86
|
SECONDARY outcome
Timeframe: at 6 months post randomizationAdherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "6 months post randomization" represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Outcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Adherence to Oral Anti-diabetic Medications
|
0.75 Adherence - proportion
Standard Deviation 0.35
|
0.74 Adherence - proportion
Standard Deviation 0.36
|
0.74 Adherence - proportion
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: at 6 months post randomizationAdherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "6 months post randomization" represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Outcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Adherence to Lipid-lowering Drugs
|
0.70 Adherence - proportion
Standard Deviation 0.37
|
0.69 Adherence - proportion
Standard Deviation 0.36
|
0.69 Adherence - proportion
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: at 24 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=568 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Cardiovascular Morbidity and Mortality (Exploratory)
|
63 participants
|
80 participants
|
58 participants
|
SECONDARY outcome
Timeframe: at 6 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Glycated Hemoglobin Levels
|
7.81 Percent
Standard Deviation 1.42
|
7.90 Percent
Standard Deviation 1.44
|
7.81 Percent
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: at 6 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=568 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
LDL Cholesterol Levels
|
92.92 mg/dL
Standard Deviation 32.33
|
92.07 mg/dL
Standard Deviation 36.68
|
91.23 mg/dL
Standard Deviation 31.17
|
SECONDARY outcome
Timeframe: at 12 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Glycated Hemoglobin Levels
|
7.94 Percent
Standard Deviation 1.60
|
7.96 Percent
Standard Deviation 1.54
|
7.84 Percent
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: at 12 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
LDL Cholesterol Levels
|
90.63 mg/dL
Standard Deviation 32.41
|
90.70 mg/dL
Standard Deviation 36.90
|
87.43 mg/dL
Standard Deviation 32.43
|
SECONDARY outcome
Timeframe: at 12 months post randomizationAdherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "12 months post randomization" represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Outcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Adherence to Oral Anti-diabetic Medications
|
0.75 Adherence - proportion
Standard Deviation 0.35
|
0.74 Adherence - proportion
Standard Deviation 0.36
|
0.74 Adherence - proportion
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: at 18 months post randomizationAdherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "18 months post randomization" represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Outcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=567 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Adherence to Oral Anti-diabetic Medications
|
0.75 Adherence - proportion
Standard Deviation 0.36
|
0.73 Adherence - proportion
Standard Deviation 0.37
|
0.73 Adherence - proportion
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: at 12 months post randomizationAdherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "12 months post randomization" represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Outcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Adherence to Lipid-lowering Drugs
|
0.70 Adherence - proportion
Standard Deviation 0.36
|
0.69 Adherence - proportion
Standard Deviation 0.37
|
0.69 Adherence - proportion
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: at 18 months post randomizationAdherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "18 months post randomization" represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Outcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Adherence to Lipid-lowering Drugs
|
0.70 Adherence - proportion
Standard Deviation 0.37
|
0.70 Adherence - proportion
Standard Deviation 0.37
|
0.70 Adherence - proportion
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: at 36 months post randomizationOutcome measures
| Measure |
Usual Care
n=567 Participants
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
|
Adherence Information
n=569 Participants
Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
|
Adherence Information Plus Motivational Interviewing
n=556 Participants
Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
|
|---|---|---|---|
|
Cardiovascular Morbidity and Mortality (Exploratory)
|
101 participants
|
112 participants
|
99 participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adherence Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adherence Information Plus Motivational Interviewing
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place