Trial Outcomes & Findings for Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (NCT NCT03973931)
NCT ID: NCT03973931
Last Updated: 2025-04-02
Results Overview
The primary outcome was medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data adjusted difference from usual care.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9501 participants
Primary outcome timeframe
12 months after intervention
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
Generic Nudge
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2377
|
2373
|
2375
|
2376
|
|
Overall Study
COMPLETED
|
2324
|
2305
|
2319
|
2321
|
|
Overall Study
NOT COMPLETED
|
53
|
68
|
56
|
55
|
Reasons for withdrawal
| Measure |
Generic Nudge
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
47
|
63
|
51
|
54
|
|
Overall Study
opted out
|
6
|
5
|
5
|
1
|
Baseline Characteristics
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
Baseline characteristics by cohort
| Measure |
Generic Nudge
n=2324 Participants
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
n=2321 Participants
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
Total
n=9269 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Medical History
Prior Myocardial Infarction
|
95 participants
n=5 Participants
|
109 participants
n=7 Participants
|
121 participants
n=5 Participants
|
98 participants
n=4 Participants
|
423 participants
n=21 Participants
|
|
Qualifying Condition
Hypertension
|
1837 participants
n=5 Participants
|
1829 participants
n=7 Participants
|
1821 participants
n=5 Participants
|
1864 participants
n=4 Participants
|
7351 participants
n=21 Participants
|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
60 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
60.0 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1087 Participants
n=5 Participants
|
1075 Participants
n=7 Participants
|
1101 Participants
n=5 Participants
|
1088 Participants
n=4 Participants
|
4351 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1237 Participants
n=5 Participants
|
1230 Participants
n=7 Participants
|
1218 Participants
n=5 Participants
|
1233 Participants
n=4 Participants
|
4918 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1100 Participants
n=5 Participants
|
1147 Participants
n=7 Participants
|
1168 Participants
n=5 Participants
|
1149 Participants
n=4 Participants
|
4564 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1204 Participants
n=5 Participants
|
1141 Participants
n=7 Participants
|
1134 Participants
n=5 Participants
|
1150 Participants
n=4 Participants
|
4629 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
391 Participants
n=5 Participants
|
378 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
1517 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1601 Participants
n=5 Participants
|
1615 Participants
n=7 Participants
|
1646 Participants
n=5 Participants
|
1598 Participants
n=4 Participants
|
6460 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
268 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
255 Participants
n=4 Participants
|
1012 Participants
n=21 Participants
|
|
Marital Status
Married Married
|
994 Participants
n=5 Participants
|
940 Participants
n=7 Participants
|
980 Participants
n=5 Participants
|
950 Participants
n=4 Participants
|
3864 Participants
n=21 Participants
|
|
Marital Status
Single
|
883 Participants
n=5 Participants
|
883 Participants
n=7 Participants
|
870 Participants
n=5 Participants
|
874 Participants
n=4 Participants
|
3510 Participants
n=21 Participants
|
|
Marital Status
Divorced/Widowed
|
434 Participants
n=5 Participants
|
464 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
483 Participants
n=4 Participants
|
1833 Participants
n=21 Participants
|
|
Marital Status
Unknown
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Insurance
Medicare
|
853 Participants
n=5 Participants
|
878 Participants
n=7 Participants
|
860 Participants
n=5 Participants
|
889 Participants
n=4 Participants
|
3480 Participants
n=21 Participants
|
|
Insurance
Medicaid
|
659 Participants
n=5 Participants
|
632 Participants
n=7 Participants
|
629 Participants
n=5 Participants
|
665 Participants
n=4 Participants
|
2585 Participants
n=21 Participants
|
|
Insurance
Commercial
|
463 Participants
n=5 Participants
|
471 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
441 Participants
n=4 Participants
|
1875 Participants
n=21 Participants
|
|
Insurance
Unknown
|
123 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
461 Participants
n=21 Participants
|
|
Insurance
VHA
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Insurance
None
|
218 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
833 Participants
n=21 Participants
|
|
Medical History
Depression
|
421 participants
n=5 Participants
|
463 participants
n=7 Participants
|
442 participants
n=5 Participants
|
416 participants
n=4 Participants
|
1742 participants
n=21 Participants
|
|
Medical History
Chronic Kidney Disease
|
191 participants
n=5 Participants
|
202 participants
n=7 Participants
|
203 participants
n=5 Participants
|
189 participants
n=4 Participants
|
785 participants
n=21 Participants
|
|
Medical History
Heart Failure
|
160 participants
n=5 Participants
|
199 participants
n=7 Participants
|
163 participants
n=5 Participants
|
171 participants
n=4 Participants
|
693 participants
n=21 Participants
|
|
Medical History
Cerebrovascular Disease
|
142 participants
n=5 Participants
|
145 participants
n=7 Participants
|
125 participants
n=5 Participants
|
134 participants
n=4 Participants
|
546 participants
n=21 Participants
|
|
Medical History
Posttraumatic Stress Disorder
|
118 participants
n=5 Participants
|
114 participants
n=7 Participants
|
102 participants
n=5 Participants
|
108 participants
n=4 Participants
|
442 participants
n=21 Participants
|
|
Medical History
Substance Abuse
|
89 participants
n=5 Participants
|
101 participants
n=7 Participants
|
116 participants
n=5 Participants
|
88 participants
n=4 Participants
|
394 participants
n=21 Participants
|
|
Medical History
Prior Coronary Revascularization
|
63 participants
n=5 Participants
|
56 participants
n=7 Participants
|
70 participants
n=5 Participants
|
58 participants
n=4 Participants
|
247 participants
n=21 Participants
|
|
Qualifying Condition
Diabetes
|
1148 participants
n=5 Participants
|
1164 participants
n=7 Participants
|
1162 participants
n=5 Participants
|
1149 participants
n=4 Participants
|
4623 participants
n=21 Participants
|
|
Qualifying Condition
Hyperlipidemia
|
1072 participants
n=5 Participants
|
1052 participants
n=7 Participants
|
1089 participants
n=5 Participants
|
1054 participants
n=4 Participants
|
4267 participants
n=21 Participants
|
|
Qualifying Condition
Coronary Artery Disease
|
305 participants
n=5 Participants
|
325 participants
n=7 Participants
|
352 participants
n=5 Participants
|
328 participants
n=4 Participants
|
1310 participants
n=21 Participants
|
|
Qualifying Condition
Atrial Fibrillation
|
132 participants
n=5 Participants
|
152 participants
n=7 Participants
|
130 participants
n=5 Participants
|
134 participants
n=4 Participants
|
548 participants
n=21 Participants
|
|
Qualifying Condition
>1 Qualifying Condition
|
1406 participants
n=5 Participants
|
1390 participants
n=7 Participants
|
1410 participants
n=5 Participants
|
1438 participants
n=4 Participants
|
5644 participants
n=21 Participants
|
|
Baseline Medication Classes
1 Active Class
|
597 Participants
n=5 Participants
|
564 Participants
n=7 Participants
|
567 Participants
n=5 Participants
|
557 Participants
n=4 Participants
|
2285 Participants
n=21 Participants
|
|
Baseline Medication Classes
2 Active Classes
|
551 Participants
n=5 Participants
|
572 Participants
n=7 Participants
|
584 Participants
n=5 Participants
|
591 Participants
n=4 Participants
|
2298 Participants
n=21 Participants
|
|
Baseline Medication Classes
>=3 Active Classes
|
1176 Participants
n=5 Participants
|
1169 Participants
n=7 Participants
|
1168 Participants
n=5 Participants
|
1173 Participants
n=4 Participants
|
4686 Participants
n=21 Participants
|
|
Intervention Delivery
Text Messages
|
2126 Participants
n=5 Participants
|
2089 Participants
n=7 Participants
|
2117 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6332 Participants
n=21 Participants
|
|
Intervention Delivery
Interactive Voice Response Telephone Messages
|
198 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
616 Participants
n=21 Participants
|
|
Intervention Delivery
No Text or IVR
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2321 Participants
n=4 Participants
|
2321 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 months after interventionPopulation: mean pdc at 12 months
The primary outcome was medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data adjusted difference from usual care.
Outcome measures
| Measure |
Generic Nudge
n=2324 Participants
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
n=2321 Participants
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
Medication Adherence
|
.606 mean PDC
Interval 0.594 to 0.618
|
.620 mean PDC
Interval 0.609 to 0.633
|
.623 mean PDC
Interval 0.612 to 0.635
|
.630 mean PDC
Interval 0.618 to 0.64
|
PRIMARY outcome
Timeframe: 12 monthsWe analyzed this longitudinal data (up to 12 observations per patient) and estimated absolute differences in PDC between treatment arms and usual care using a Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations .A multistage gatekeeper approach was used to account for multiple treatment comparisons by comparing each of the 3 treatment arms to the control in stage 1 using significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm method was used for the 3 pairwise comparisons, where R is the number of significant stage 1 tests.
Outcome measures
| Measure |
Generic Nudge
n=2324 Participants
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
Mean Proportion of Days Covered Relative to Usual Care
|
0.022 proportion of days covered
Interval 0.003 to 0.042
|
0.020 proportion of days covered
Interval 0.001 to 0.039
|
0.023 proportion of days covered
Interval 0.004 to 0.042
|
—
|
SECONDARY outcome
Timeframe: one yearPopulation: 1-year Kaplan-Meier rate estimates with 95% confidence intervals.
estimated probability of hospitalization at one year
Outcome measures
| Measure |
Generic Nudge
n=2324 Participants
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
n=2321 Participants
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
Hospitalization
|
.13 estimated probability of hospitalization
Interval 0.115 to 0.144
|
.136 estimated probability of hospitalization
Interval 0.121 to 0.151
|
.136 estimated probability of hospitalization
Interval 0.121 to 0.151
|
.143 estimated probability of hospitalization
Interval 0.128 to 0.158
|
SECONDARY outcome
Timeframe: one yearPopulation: 1-year Kaplan-Meier rate estimates with 95% confidence intervals.
estimated probability of death at one year
Outcome measures
| Measure |
Generic Nudge
n=2324 Participants
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
n=2321 Participants
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
Death
|
.031 estimated probability of death
Interval 0.03 to 0.039
|
.026 estimated probability of death
Interval 0.019 to 0.033
|
.027 estimated probability of death
Interval 0.02 to 0.034
|
.033 estimated probability of death
Interval 0.025 to 0.041
|
SECONDARY outcome
Timeframe: one yearPopulation: 1-year Kaplan-Meier rate estimates with 95% confidence intervals.
estimated probability of emergency department visit at one year
Outcome measures
| Measure |
Generic Nudge
n=2324 Participants
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 Participants
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
n=2321 Participants
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
Emergency Department Visit
|
.292 estimated probability of ED visit
Interval 0.272 to 0.311
|
.285 estimated probability of ED visit
Interval 0.265 to 0.305
|
.294 estimated probability of ED visit
Interval 0.274 to 0.313
|
.301 estimated probability of ED visit
Interval 0.281 to 0.321
|
Adverse Events
Generic Nudge
Serious events: 267 serious events
Other events: 612 other events
Deaths: 63 deaths
Optimized Nudge
Serious events: 283 serious events
Other events: 594 other events
Deaths: 53 deaths
Optimized Nudge Plus AI Chat Bot
Serious events: 283 serious events
Other events: 616 other events
Deaths: 55 deaths
Usual Care
Serious events: 303 serious events
Other events: 639 other events
Deaths: 68 deaths
Serious adverse events
| Measure |
Generic Nudge
n=2324 participants at risk
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 participants at risk
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 participants at risk
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
n=2321 participants at risk
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
General disorders
Number with All Cause Hospitalization in 12 months
|
11.5%
267/2324 • Number of events 267 • 12 months
All-Cause Mortality
|
12.3%
283/2305 • Number of events 283 • 12 months
All-Cause Mortality
|
12.2%
283/2319 • Number of events 283 • 12 months
All-Cause Mortality
|
13.1%
303/2321 • Number of events 303 • 12 months
All-Cause Mortality
|
Other adverse events
| Measure |
Generic Nudge
n=2324 participants at risk
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge
n=2305 participants at risk
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Optimized Nudge Plus AI Chat Bot
n=2319 participants at risk
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge: Interventions will include a variety of text messages aimed at improving medication adherence.
|
Usual Care
n=2321 participants at risk
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
|
|---|---|---|---|---|
|
General disorders
Number with Emergency Department visits in 12 months
|
26.3%
612/2324 • Number of events 612 • 12 months
All-Cause Mortality
|
25.8%
594/2305 • Number of events 594 • 12 months
All-Cause Mortality
|
26.6%
616/2319 • Number of events 616 • 12 months
All-Cause Mortality
|
27.5%
639/2321 • Number of events 639 • 12 months
All-Cause Mortality
|
Additional Information
Dr. Michael Ho
University of Colorado
Phone: 303-590-5969
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place