Trial Outcomes & Findings for Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence (NCT NCT02690649)

NCT ID: NCT02690649

Last Updated: 2021-10-28

Results Overview

AdhereTech smart pill bottles used to collect medication dosing = percentage of allotted doses that were recorded as taken

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: 6 months during study
• Results posted on: 2021-10-28

Participant Flow

Participant milestones

Measure	Health Messaging (Non-Procedural) PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Overall Study STARTED	80	80
Overall Study COMPLETED	79	76
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Health Messaging (Non-Procedural) PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Health Messaging (Non-Procedural) n=80 Participants PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging n=80 Participants No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.	Total n=160 Participants Total of all reporting groups
Age, Continuous	70.78 years STANDARD_DEVIATION 8.65 • n=80 Participants	71.51 years STANDARD_DEVIATION 8.21 • n=80 Participants	71.14 years STANDARD_DEVIATION 8.41 • n=160 Participants
Sex: Female, Male Female	31 Participants n=80 Participants	29 Participants n=80 Participants	60 Participants n=160 Participants
Sex: Female, Male Male	49 Participants n=80 Participants	51 Participants n=80 Participants	100 Participants n=160 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Atrial Fibrillation Knowledge	6.94 units on a scale STANDARD_DEVIATION 1.93 • n=80 Participants	6.59 units on a scale STANDARD_DEVIATION 2.13 • n=80 Participants	6.76 units on a scale STANDARD_DEVIATION 2.04 • n=160 Participants
Pre-intervention Patient Portal Logins	17.80 logins STANDARD_DEVIATION 18.83 • n=80 Participants	18.60 logins STANDARD_DEVIATION 20.85 • n=80 Participants	18.20 logins STANDARD_DEVIATION 19.80 • n=160 Participants
Medication Type Warfarin	40 Participants n=80 Participants	40 Participants n=80 Participants	80 Participants n=160 Participants
Medication Type Xarelto	17 Participants n=80 Participants	12 Participants n=80 Participants	29 Participants n=160 Participants
Medication Type Eliquis	23 Participants n=80 Participants	28 Participants n=80 Participants	51 Participants n=160 Participants
Atrial fibrillation diagnosis in previous 12 months Yes	17 Participants n=80 Participants	7 Participants n=80 Participants	24 Participants n=160 Participants
Atrial fibrillation diagnosis in previous 12 months No	63 Participants n=80 Participants	73 Participants n=80 Participants	136 Participants n=160 Participants

PRIMARY outcome

Timeframe: 6 months during study

AdhereTech smart pill bottles used to collect medication dosing = percentage of allotted doses that were recorded as taken

Outcome measures

Measure	Health Messaging (Non-Procedural) n=79 Participants PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging n=76 Participants No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Medication Adherence	93.08 percentage of doses recorded as taken Standard Deviation 0.01	89.52 percentage of doses recorded as taken Standard Deviation 0.01

SECONDARY outcome

Timeframe: 6 months during study

The number of times participants logged into their patient portal (Epic's MyChart) during the study period was used as a proxy for patient engagement.

Outcome measures

Measure	Health Messaging (Non-Procedural) n=80 Participants PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging n=80 Participants No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Patient Portal Login	42.7 Count of MyChart patient portal logins Standard Deviation 37.0	15.9 Count of MyChart patient portal logins Standard Deviation 16.0

SECONDARY outcome

Timeframe: 6 months

End of study score on Atrial Fibrillation Knowledge scale (min:0 is no knowledge, max: 11 is high knowledge), adjusted for age, baseline knowledge, gender and education level.

Outcome measures

Measure	Health Messaging (Non-Procedural) n=77 Participants PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging n=72 Participants No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Atrial Fibrillation Knowledge	7.31 score on a scale Standard Deviation 1.92	6.64 score on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: 6 months during study

Adverse events include death, stroke, any embolic event, and/or major bleeding.

Outcome measures

Measure	Health Messaging (Non-Procedural) n=80 Participants PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging n=80 Participants No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Number of Patients With Incidence of Adverse Events	11 Participants	6 Participants

Adverse Events

Health Messaging (Non-Procedural)

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

No Health Messaging

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Health Messaging (Non-Procedural) n=80 participants at risk PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging n=80 participants at risk No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Infections and infestations Influenza A	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Gastrointestinal disorders GI Bleed	2.5% 2/80 • Number of events 2 • 6 months time of study The intervention was education only; not clinical.	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.
Infections and infestations Urinary Tract Infection	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.
Cardiac disorders Chest Pain	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Nervous system disorders Vascular Parkinsonism with dementia	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.

Other adverse events

Measure	Health Messaging (Non-Procedural) n=80 participants at risk PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.	No Health Messaging n=80 participants at risk No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Cardiac disorders Worsening Dyspnea	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Ear and labyrinth disorders Vestibular Schwannoma	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Musculoskeletal and connective tissue disorders Ankle pain, arthritis	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.
Cardiac disorders Palpitations	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Gastrointestinal disorders Abdominal pain	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.
General disorders Penile and Scrotal Rash	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.
General disorders Hematuria	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Cardiac disorders Chest Pain	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Cardiac disorders Atrial Fibrillation	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
General disorders Gout	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.
Endocrine disorders Diabetes Type 2	0.00% 0/80 • 6 months time of study The intervention was education only; not clinical.	1.2% 1/80 • Number of events 1 • 6 months time of study The intervention was education only; not clinical.

Additional Information

Julie Hughbanks

Parkview Health

Phone: 260-266-1444

Email: julie.hughbanks@parkview.com

Results disclosure agreements

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