Digital Outreach for Heart Failure Adherence
ConditionCHF - Congestive Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Permanente
About this trial
The goal of the ADHERE-HF study is to evaluate whether care-embedded, operationally delivered digital outreach improves medication refill, adherence, and clinical outcomes among adults with heart failure who are overdue for a refill of an eligible guideline-directed medical therapy (GDMT) medication.
The main question it aims to answer is: Does digital outreach using interactive text messages or automated telephone calls increase short-term refill of overdue heart failure medications compared with usual care?
The study will evaluate the effectiveness of a digital outreach strategy delivered through existing health system communication channels. Members who have opted in to pharmacy text messaging will receive interactive text messages, while those who have not opted in will receive an interactive automated telephone call. The comparison group will receive usual care with no additional outreach.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Active KPNC membership
Heart failure diagnosis documented at least 6 months before the index date, with a documented EF
HFpEF (EF≥50%): ARNI (sacubitril/valsartan); MRA; SGLT2i
Disqualifiers
Documented allergy or intolerance to all eligible GDMT medications for which the patient is overdue
Receiving hospice or comfort-focused care
Skilled nursing facility stay within prior 12 months
No valid telephone number on file through which the patient could be reached by text message or automated telephone call
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Outreach
BehavioralParticipants assigned to this arm will receive digital outreach encouraging refill of overdue guideline-directed medical therapy (GDMT) medications for heart failure. Participants who have opted in to pharmacy text messaging at the time of outreach will receive interactive text messages. Participants who have not opted in to pharmacy text messaging will receive an interactive automated telephone call. Participants may receive additional outreach during the 12-month intervention period if another eligible GDMT medication becomes overdue.
Treatment groups
13,714 Participants
are divided into 2 treatment groupsGroup A: Digital OutreachExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Refill of at least one overdue GDMT medication (within 14 days)
Proportion of participants who refill at least one guideline-directed medical therapy (GDMT) medication for which they were overdue at randomization (index) based on pharmacy dispensing records.
Time frame
Within 14 days after outreachSecondary outcomes
1
Composite of heart failure hospitalization or all-cause death
Time to first occurrence of heart failure hospitalization or death from any cause.
Time frame
Up to 12 months after randomization2
Time to first refill of an overdue GDMT medication
Time from outreach to refill of any GDMT medication for which the participant was overdue at randomization, measured using pharmacy dispensing records. Participants who do not refill will be censored at disenrollment, death, or 28 days after outreach.
Time frame
Up to 28 days after outreach3
Refill of at least one overdue GDMT medication (within 28 days)
Proportion of participants who refill at least one GDMT medication for which they were overdue at randomization, based on pharmacy dispensing records.
Time frame
Within 28 days after outreach4
Proportion of overdue GDMT medications refilled (within 14 days)
For each participant, the proportion of GDMT medications overdue at randomization that are refilled, determined from pharmacy dispensing records.
Time frame
Within 14 days after outreachSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: