Trial Outcomes & Findings for Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (NCT NCT02846779)
NCT ID: NCT02846779
Last Updated: 2019-08-07
Results Overview
Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6000 participants
Primary outcome timeframe
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Results posted on
2019-08-07
Participant Flow
Participant milestones
| Measure |
Low Intensity
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Overall Study
STARTED
|
2000
|
2000
|
2000
|
|
Overall Study
COMPLETED
|
1861
|
1873
|
1862
|
|
Overall Study
NOT COMPLETED
|
139
|
127
|
138
|
Reasons for withdrawal
| Measure |
Low Intensity
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Overall Study
Lost Enrollment
|
83
|
82
|
86
|
|
Overall Study
Less than 31 days of follow-up
|
56
|
45
|
52
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Intensity
n=1861 Participants
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
n=1873 Participants
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
n=1862 Participants
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
Total
n=5596 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 11.0 • n=1861 Participants
|
55.6 years
STANDARD_DEVIATION 11.3 • n=1873 Participants
|
55.9 years
STANDARD_DEVIATION 10.7 • n=1862 Participants
|
55.9 years
STANDARD_DEVIATION 11.0 • n=5596 Participants
|
|
Sex: Female, Male
Female
|
751 Participants
n=1861 Participants
|
738 Participants
n=1873 Participants
|
763 Participants
n=1862 Participants
|
2252 Participants
n=5596 Participants
|
|
Sex: Female, Male
Male
|
1110 Participants
n=1861 Participants
|
1135 Participants
n=1873 Participants
|
1099 Participants
n=1862 Participants
|
3344 Participants
n=5596 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1861 participants
n=1861 Participants
|
1873 participants
n=1873 Participants
|
1862 participants
n=1862 Participants
|
5596 participants
n=5596 Participants
|
|
Hemoglobin A1c
|
8.5 % of glycated hemoglobin (A1c)
STANDARD_DEVIATION 1.8 • n=1861 Participants
|
8.5 % of glycated hemoglobin (A1c)
STANDARD_DEVIATION 1.8 • n=1873 Participants
|
8.6 % of glycated hemoglobin (A1c)
STANDARD_DEVIATION 1.8 • n=1862 Participants
|
8.5 % of glycated hemoglobin (A1c)
STANDARD_DEVIATION 1.9 • n=5596 Participants
|
|
At least 1 HbA1c value available
|
663 Participants
n=1861 Participants
|
640 Participants
n=1873 Participants
|
642 Participants
n=1862 Participants
|
1945 Participants
n=5596 Participants
|
|
Short or rapid-acting insulin use
|
954 Participants
n=1861 Participants
|
930 Participants
n=1873 Participants
|
965 Participants
n=1862 Participants
|
2849 Participants
n=5596 Participants
|
|
Number of basal insulin claims
|
2.6 Basal insulin claims
STANDARD_DEVIATION 1.9 • n=1861 Participants
|
2.6 Basal insulin claims
STANDARD_DEVIATION 1.8 • n=1873 Participants
|
2.6 Basal insulin claims
STANDARD_DEVIATION 1.9 • n=1862 Participants
|
2.6 Basal insulin claims
STANDARD_DEVIATION 1.9 • n=5596 Participants
|
|
Use of adjunct oral hypoglycemic
|
1220 Participants
n=1861 Participants
|
1242 Participants
n=1873 Participants
|
1227 Participants
n=1862 Participants
|
3689 Participants
n=5596 Participants
|
|
Hypoglycemia
|
86 Participants
n=1861 Participants
|
88 Participants
n=1873 Participants
|
87 Participants
n=1862 Participants
|
261 Participants
n=5596 Participants
|
|
Ketoacidosis
|
48 Participants
n=1861 Participants
|
54 Participants
n=1873 Participants
|
41 Participants
n=1862 Participants
|
143 Participants
n=5596 Participants
|
|
Retinopathy
|
184 Participants
n=1861 Participants
|
156 Participants
n=1873 Participants
|
170 Participants
n=1862 Participants
|
510 Participants
n=5596 Participants
|
|
Nephropathy
|
46 Participants
n=1861 Participants
|
47 Participants
n=1873 Participants
|
28 Participants
n=1862 Participants
|
121 Participants
n=5596 Participants
|
|
Neuropathy
|
431 Participants
n=1861 Participants
|
419 Participants
n=1873 Participants
|
412 Participants
n=1862 Participants
|
1262 Participants
n=5596 Participants
|
|
Coronary artery disease
|
391 Participants
n=1861 Participants
|
405 Participants
n=1873 Participants
|
382 Participants
n=1862 Participants
|
1178 Participants
n=5596 Participants
|
|
Hypertension
|
1381 Participants
n=1861 Participants
|
1409 Participants
n=1873 Participants
|
1429 Participants
n=1862 Participants
|
4219 Participants
n=5596 Participants
|
|
Hyperlipidemia
|
1278 Participants
n=1861 Participants
|
1248 Participants
n=1873 Participants
|
1275 Participants
n=1862 Participants
|
3801 Participants
n=5596 Participants
|
|
Congestive heart failure
|
129 Participants
n=1861 Participants
|
147 Participants
n=1873 Participants
|
136 Participants
n=1862 Participants
|
412 Participants
n=5596 Participants
|
|
Stroke/Transient ischemic attack
|
95 Participants
n=1861 Participants
|
102 Participants
n=1873 Participants
|
103 Participants
n=1862 Participants
|
300 Participants
n=5596 Participants
|
|
Obesity
|
461 Participants
n=1861 Participants
|
472 Participants
n=1873 Participants
|
497 Participants
n=1862 Participants
|
1430 Participants
n=5596 Participants
|
|
Asthma/COPD
|
254 Participants
n=1861 Participants
|
244 Participants
n=1873 Participants
|
226 Participants
n=1862 Participants
|
724 Participants
n=5596 Participants
|
|
Cancer
|
235 Participants
n=1861 Participants
|
221 Participants
n=1873 Participants
|
220 Participants
n=1862 Participants
|
676 Participants
n=5596 Participants
|
|
Liver Disease
|
130 Participants
n=1861 Participants
|
142 Participants
n=1873 Participants
|
138 Participants
n=1862 Participants
|
410 Participants
n=5596 Participants
|
|
Chronic Kidney Disease
|
1227 Participants
n=1861 Participants
|
1222 Participants
n=1873 Participants
|
1204 Participants
n=1862 Participants
|
3653 Participants
n=5596 Participants
|
|
Depression
|
143 Participants
n=1861 Participants
|
135 Participants
n=1873 Participants
|
134 Participants
n=1862 Participants
|
412 Participants
n=5596 Participants
|
|
Dementia
|
40 Participants
n=1861 Participants
|
34 Participants
n=1873 Participants
|
36 Participants
n=1862 Participants
|
110 Participants
n=5596 Participants
|
|
Acute Stress
|
68 Participants
n=1861 Participants
|
62 Participants
n=1873 Participants
|
57 Participants
n=1862 Participants
|
187 Participants
n=5596 Participants
|
|
Days hospitalized
|
2.17 Days
STANDARD_DEVIATION 11.1 • n=1861 Participants
|
2.2 Days
STANDARD_DEVIATION 10.1 • n=1873 Participants
|
2.0 Days
STANDARD_DEVIATION 7.6 • n=1862 Participants
|
2.1 Days
STANDARD_DEVIATION 11.0 • n=5596 Participants
|
|
Number of Hospitalizations
|
0.3 Hospitalizations
STANDARD_DEVIATION 0.9 • n=1861 Participants
|
0.3 Hospitalizations
STANDARD_DEVIATION 1.3 • n=1873 Participants
|
0.3 Hospitalizations
STANDARD_DEVIATION 0.8 • n=1862 Participants
|
0.3 Hospitalizations
STANDARD_DEVIATION 1.4 • n=5596 Participants
|
|
Number of Office visits
|
9.5 Office Visits
STANDARD_DEVIATION 8.0 • n=1861 Participants
|
9.3 Office Visits
STANDARD_DEVIATION 7.6 • n=1873 Participants
|
9.3 Office Visits
STANDARD_DEVIATION 7.7 • n=1862 Participants
|
9.3 Office Visits
STANDARD_DEVIATION 7.7 • n=5596 Participants
|
PRIMARY outcome
Timeframe: From 1 month (30 days) after randomization through 12 months (365 days) after randomizationPercentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period
Outcome measures
| Measure |
Low Intensity
n=1861 Participants
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
n=1873 Participants
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
n=1862 Participants
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Insulin Persistence
|
5.4 Percentage of participants
|
4.7 Percentage of participants
|
4.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From 1 month (30 days) after randomization through 12 months (365 days) after randomizationThe percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available.
Outcome measures
| Measure |
Low Intensity
n=663 Participants
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
n=640 Participants
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
n=642 Participants
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Change in Glycated Hemoglobin Level (HbA1c)
|
-0.06 Percent change
Standard Deviation 1.48
|
-0.21 Percent change
Standard Deviation 1.37
|
-0.31 Percent change
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: From 1 month (30 days) after randomization through 12 months (365 days) after randomizationHealth care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period
Outcome measures
| Measure |
Low Intensity
n=1861 Participants
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
n=1873 Participants
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
n=1862 Participants
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Health Care Spending
|
22616 Dollars
Standard Deviation 49250
|
23284 Dollars
Standard Deviation 49094
|
22545 Dollars
Standard Deviation 44448
|
SECONDARY outcome
Timeframe: From 1 month (30 days) after randomization through 12 months (365 days) after randomizationNumber of all-cause physician office visits over the entire follow-up period
Outcome measures
| Measure |
Low Intensity
n=1861 Participants
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
n=1873 Participants
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
n=1862 Participants
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Number of Physician Office Visits
|
7.66 Physician office visits
Standard Deviation 7.29
|
7.62 Physician office visits
Standard Deviation 7.17
|
7.50 Physician office visits
Standard Deviation 7.27
|
SECONDARY outcome
Timeframe: From 1 month (30 days) after randomization through 12 months (365 days) after randomizationNumber of all-cause emergency room visits over the entire follow-up period
Outcome measures
| Measure |
Low Intensity
n=1861 Participants
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
n=1873 Participants
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
n=1862 Participants
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Number of Emergency Room Visits
|
0.31 ER visits
Standard Deviation 1.00
|
0.43 ER visits
Standard Deviation 4.40
|
0.30 ER visits
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: From 1 month (30 days) after randomization through 12 months (365 days) after randomizationNumber of All-cause hospitalizations over the entire follow-up period
Outcome measures
| Measure |
Low Intensity
n=1861 Participants
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach
|
Moderate Intensity
n=1873 Participants
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach
|
High Intensity
n=1862 Participants
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach
|
|---|---|---|---|
|
Number of Hospitalizations
|
0.19 Hospitalizations
Standard Deviation 0.63
|
0.23 Hospitalizations
Standard Deviation 0.72
|
0.21 Hospitalizations
Standard Deviation 0.65
|
Adverse Events
Low Intensity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Intensity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Intensity
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
Niteesh K. Choudhry, MD, PhD
Brigham and Women's Hospital
Phone: 617-278-0930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place