[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656861":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":56,"studyPopulation":50,"armGroups":57,"interventions":68,"overallOfficials":50,"centralContacts":50,"locations":73,"responsibleParty":87,"collaborators":50,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":50,"enrollmentInfo":99,"targetDuration":50,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":125,"whyStopped":50,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Kaiser Permanente","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Within 14 days after outreach",[14,18,22,26,29,31,34,37,40,43,47],{"measure":15,"description":16,"timeFrame":17},"Composite of heart failure hospitalization or all-cause death","Time to first occurrence of heart failure hospitalization or death from any cause.","Up to 12 months after randomization",{"measure":19,"description":20,"timeFrame":21},"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.","Up to 28 days after outreach",{"measure":23,"description":24,"timeFrame":25},"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.","Within 28 days after outreach",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":28,"timeFrame":25},"Proportion of overdue GDMT medications refilled (within 28 days)",{"measure":32,"description":33,"timeFrame":17},"Heart failure hospitalization","Time to first heart failure hospitalization.",{"measure":35,"description":36,"timeFrame":17},"All-cause death","Time to death from any cause",{"measure":38,"description":39,"timeFrame":17},"Recurrent heart failure hospitalizations","Total number of heart failure hospitalizations occurring during follow-up.",{"measure":41,"description":42,"timeFrame":12},"Mail-order fulfillment","Proportion of participants who receive a mail-order dispense for at least one GDMT medication that was overdue at randomization.",{"measure":44,"description":45,"timeFrame":46},"GDMT adherence (proportion of days covered)","Adherence to GDMT measured as proportion of days covered (PDC). PDC will be calculated separately by GDMT class and overall across prescribed classes.","At 6 months and 12 months after randomization",{"measure":48,"description":49,"timeFrame":46},"GDMT persistence","Persistence with GDMT therapy, defined as time to the first gap in medication supply exceeding 60 days. Persistence will be evaluated separately by GDMT class prescribed.",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":6,"observationalModel":50,"timePerspective":50,"maskingInfo":54},"RANDOMIZED","PARALLEL",{"masking":55,"maskingDescription":50,"whoMasked":50},"NONE","Heart failure is a common chronic condition associated with hospitalization, impaired quality of life, and premature death. Guideline-directed medical therapy (GDMT) can reduce the risk of cardiovascular death and worsening heart failure, but patients must continue to refill and take these medications to receive their full benefit. Medication nonadherence remains common and contributes to a gap between the benefits observed in clinical trials and those achieved in routine care. The ADHERE-HF study is a pragmatic, prospective, open-label, individual-level randomized clinical trial designed to evaluate whether digital outreach improves refill of overdue GDMT medications among adults with heart failure. The study will compare a text-first digital outreach strategy with usual care and will be conducted through existing health system pharmacy operations.\n\nEligible members will be randomized in a 1:1 ratio to operationally conducted digital outreach or usual care. Randomization will be stratified by ejection fraction category and by whether the member has opted in to pharmacy text outreach at the time of randomization. Members assigned to digital outreach who have opted in to pharmacy text messaging will receive interactive two-way text messages. These messages notify members that they may be due for a medication refill and provide options to request mail-order delivery or pharmacy pickup. Responses indicating medication, cost, dosing, or other concerns may be referred to pharmacy staff for follow-up. Members assigned to digital outreach who have not opted in to pharmacy text messaging will receive an interactive automated telephone call. The call allows members to select among refill options using the telephone keypad. Members may request refill at their usual pharmacy, use or establish mail-order delivery, or transfer to a pharmacy representative for assistance. Members assigned to usual care will receive no additional outreach. All members will continue to receive routine pharmacy refill communications and other standard health system services. Members will remain assigned to their randomized strategy for 12 months. If any eligible GDMT medication becomes overdue during follow-up, members in the digital outreach group may receive additional outreach. Outreach modality will be based on each member's pharmacy text opt-in status at the time of each contact.\n\nThe primary outcome is refill, within 14 days of the outreach date, of at least one GDMT medication that was overdue at randomization. Secondary outcomes include refill within 28 days, the proportion of overdue medications refilled, time to first refill, mail-order fulfillment, medication adherence and persistence at 6 and 12 months, heart failure hospitalization, and all-cause mortality. All outcomes will be obtained from routinely collected, operationally available pharmacy dispensing, electronic health record, administrative, and digital communication data.\n\nThe study has no study-specific visits or any direct contact by the study team. This study is designed to generate care-embedded, actionable evidence within a learning health system by determining whether scalable digital outreach improves refill and adherence to guideline-directed heart failure medications and whether the strategy should be implemented more broadly.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Digital Outreach","EXPERIMENTAL","Participants will receive interactive text messages or automated phone calls encouraging refill of overdue heart failure medications.",[63],"Behavioral: Digital Outreach",{"label":65,"type":66,"description":67,"interventionNames":50},"Usual Care","NO_INTERVENTION","Participants in this arm will receive usual care with no proactive outreach during the study period.",[69],{"type":70,"name":59,"description":71,"armGroupLabels":72,"otherNames":50},"BEHAVIORAL","Participants 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.",[59],[74],{"facility":75,"status":50,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":50},"Kaiser Permanente Division of Research","Pleasanton","California","94588","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-121.87468,37.66243,{"lat":85,"lon":84},{"type":88,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100656861","digital-outreach-for-heart-failure-adherence-100656861",false,"NCT07831538","Digital Outreach for Heart Failure Adherence","Adherence Through Digital Health: Evaluating Randomized Engagement in Heart Failure","ADHERE-HF","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Active KPNC membership\n3. Heart failure diagnosis documented at least 6 months before the index date, with a documented EF\n4. Prescribed at least one eligible GDMT medication for ≥6 months:\n\n   1. HFpEF (EF≥50%): ARNI (sacubitril\u002Fvalsartan); MRA; SGLT2i\n   2. HFrEF or HFmrEF (EF \\\u003C50%): ARNI (sacubitril\u002Fvalsartan), ACEi, or ARB; Beta-blocker (bisoprolol, carvedilol, or sustained-release metoprolol succinate); MRA; SGLT2i\n5. At least one unfilled refill for an eligible GDMT medication that is 7-13 days overdue at index\n\nExclusion Criteria:\n\n1. Documented allergy or intolerance to all eligible GDMT medications for which the patient is overdue\n2. Receiving hospice or comfort-focused care\n3. Skilled nursing facility stay within prior 12 months\n4. No valid telephone number on file through which the patient could be reached by text message or automated telephone call\n5. Opted out of receiving pharmacy medication adherence outreach from Kaiser Permanente\n6. Other conditions that prevent outreach","ALL","18 Years",{"count":100,"type":101},13714,"ESTIMATED","INTERVENTIONAL",[104],"NA","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.\n\nThe 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?\n\nThe 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.",[107],"CHF - Congestive Heart Failure",[109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"Heart failure","Heart failure management","Guideline-directed medical therapy","GDMT","Medication adherence","Medication nonadherence","Medication refill","Digital outreach","Patient outreach","Text messaging","SMS","Automated telephone calls","Interactive voice response","Pharmacy outreach","Pragmatic randomized trial","Learning health system","NOT_YET_RECRUITING","2026-09-28",{"date":128,"type":129},"2026-10-01","ACTUAL",{"date":131,"type":101},"2026-09-21",{"date":133,"type":101},"2028-03",{"name":5,"class":6},1]