Developing a Heart Failure Polypill to Improve Outcomes at a Safety Net Hospital: A Pilot Crossover Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Measured Adherence to GDMT by Pill Count
研究概览
简要总结
A novel four-drug regimen for heart failure with reduced ejection fraction (HFrEF) extends patients' life expectancy by an average of 6 years compared to traditional therapies, in addition to improving quality of life. Unfortunately, uptake of this complex multi-drug regimen has been low, especially among underserved communities with barriers to medication adherence. Although combination tablets have transformed access to care for conditions such as HIV and tuberculosis, no combination pill is available for HFrEF.
In the proposed study, the investigators will utilize inexpensive over-encapsulation techniques to develop a novel combination pill ("polypill") for patients with HFrEF. In Aim 1, the investigators will conduct stakeholder interviews with patients, providers, and pharmacists to inform the design of a HFrEF polypill. In Aim 2, the investigators will conduct a pilot, single-center, crossover randomized clinical trial to investigate whether, compared to usual care, a HFrEF polypill increases medication adherence among 20-40 adults with HFrEF. Given the high daily pill burden among patients with HIV and HFrEF, the investigators aim to recruit a subgroup of patients with HIV (~10-20 participants) in addition to a subgroup of patients without HIV (~10-20 participants).
详细描述
Hypothesis: Compared with usual care, a HFrEF polypill implementation strategy will increase adherence to GDMT 4 weeks and reduce total daily pill burden among patients with HFrEF.
Rationale:HFrEF among PWH is associated with a high pill burden, which adversely impacts adherence. Over-encapsulation is an inexpensive and replicable method to co-package several tablets into a single capsule at the level of the pharmacy. However, the role of over-encapsulation to reduce pill burden among adults with HIV and HFrEF is unknown.
Design: Pilot phase II open-label randomized trial with a 2x2 crossover design (AB/BA)
Intervention: The intervention will be pharmacy-level over-encapsulation of once-daily heart failure medications (beta-blocker, SGLT2 inhibitor, spironolactone, and ACE/ARB/ARNI) into a single capsule. For some patients, other once-daily cardiovascular medications, such as a diuretic, may be included if capsule size allows (otherwise, these medications will continued to be filled separate to the polypill, as individual tablets). If the patient uses a twice-daily ARNI medication, the morning dose may be included in the polypill and the PM dose will continue to be dispensed separately. The investigators will partner with Daniel's Pharmacy, a local community pharmacy with proficiency in over-encapsulation and over 20 years' experience working with ZSFG to deliver adherence interventions.
Polypill Description: For patients in the polypill arm, heart failure medications will be filled as usual, but rather than dispensing each medication separately, the pharmacy technician will hand-pack all once-daily heart failure medications into a small plastic capsule. The doses will be individualized to the patient based on their physician's prescription. Thus, the polypill will be a late-stage implementation intervention to reduce pill burden, without restricting dose possibilities or interfering with medication titration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GDMT delivered in a heart failure polypill
The polypill intervention will be pharmacy-level over-encapsulation of heart failure medications (beta-blocker, SGLT2 inhibitor, mineralocorticoid receptor antagonist, and ACE/ARB/ARNI) into a single capsule. For patients on twice-daily sacubitril/valsartan, one dose will be included in the polypill and the second dose will be dispensed separately. The investigators will partner with a local community pharmacy with proficiency in over-encapsulation. For patients in the polypill arm, heart failure medications will be filled as usual, but rather than dispensing each medication separately, the pharmacy technician will hand-pack all once-daily heart failure medications into a small vegan capsule.
干预措施: Heart failure polypill (Drug)
GDMT delivered as individual tablets
As described above, participants who are not already prescribed a beta blocker, SGLT2i, ACE/ARB/ARNI, and MRA will be initiated on these medications prior to randomization if no contraindications exist. Participants randomized to usual care will receive their heart failure medications as individual pills. They will have the option to receive medications by mail, clinic pick-up, or pharmacy pick-up.
干预措施: Control Rx (Drug)
结局指标
主要结局
Measured Adherence to GDMT by Pill Count
时间窗: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
The primary outcome will be overall adherence to GDMT, as determined by pill count. We will first calculate the % adherence ratio for each prescribed class of GDMT (# pills missing / # pills supposed to be missing). The adherence ratio for each prescribed class of GDMT will then be averaged to derive the overall adherence ratio to GDMT. Pill count may be performed in-office or over videoconferencing.
次要结局
- Morisky Medication Adherence-8 (MMAS-8) Questionnaire(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM 9)(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Heart Failure Admission Rate(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) 12(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Adherence Ratio to Individual Components of GDMT by Pill Count(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Blood Pressure (mmHg)(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Heart Rate(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Weight(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- NT-ProBNP(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Adverse Events(0, 2, 4, 6, and 8 weeks)
- Total Daily Pill Burden of the Patient(The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.)
- Number of GDMT Pillars Prescribed(The outcome will be measured 1) at the start of the polypill intervention, and 2) at the start of the individual tablet intervention.)
- HFrEF Polypill Patient Satisfaction Exit Survey(After study completion)
- Number of Participants Completing a Qualitative Exit Interview(After study completion (between 8 and 12 weeks))
- Implementation Outcome: Time Required to Manufacture the HFrEF Polypill at Our Community Pharmacy Partner(Assessed at week 0 or week 4)
- Implementation Outcome: Cost of HFrEF Polypill Manufacturing at Our Community Pharmacy Partner(Assessed at week 0 or week 4)
- Number of Days Off of GDMT(Assessed at weeks 4 and 8)