The Impact of Nurse Practitioner-Led Multidisciplinary Team Intervention on the Implementation of Guideline-Directed Medical Therapy and Clinical Outcomes in Adults With Multimorbidity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 178
- 主要终点
- GDMT Implementation Rate at Hospital Discharge
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a nurse practitioner-led multidisciplinary team (NP-led MDT) intervention can improve the use of guideline-directed medical therapy (GDMT) and short-term clinical outcomes in hospitalized adults with multimorbidity in a multidisciplinary medicine ward.
The main questions it aims to answer are:
Does NP-led MDT intervention increase the proportion of patients achieving GDMT at hospital discharge?
Does NP-led MDT intervention reduce 30-, 60-, and 90-day readmission, emergency department visits, and mortality?
Researchers will compare the NP-led MDT intervention group with the usual care group to see if the intervention improves GDMT implementation and clinical outcomes.
Participants will:
Be randomly assigned to NP-led MDT care or usual care.
Have their medications reviewed according to the latest guidelines (intervention group only).
Be followed for 90 days after discharge to collect outcomes through medical record review and telephone follow-up.
详细描述
This is a prospective, single-center, randomized controlled trial designed to evaluate whether a nurse practitioner-led multidisciplinary team (NP-led MDT) intervention can improve the implementation rate of guideline-directed medical therapy (GDMT) and short-term clinical outcomes in hospitalized adults with multimorbidity. Multimorbidity is defined as the coexistence of two or more chronic conditions, including heart failure, hypertension, diabetes mellitus, chronic kidney disease, ischemic heart disease, and chronic obstructive pulmonary disease. Suboptimal use of GDMT is common in this population, contributing to poor clinical outcomes.
Eligible patients admitted from the emergency department to the multidisciplinary medicine ward of a tertiary medical center will be screened within 72 hours of admission. Participants will be randomly assigned in a 1:1 ratio to either the NP-led MDT intervention group or the usual care group.
In the intervention group, the NP-led MDT-comprising a nurse practitioner, physicians, and clinical pharmacists-will review each patient's diagnoses, comorbidities, baseline medications, and relevant laboratory or imaging results. Based on the latest international guidelines, the team will formulate individualized GDMT recommendations, which will be communicated to the patient's primary inpatient care team. The NP will also provide patient and caregiver education on medication adherence, potential side effects, and follow-up requirements. All final prescribing decisions will be made by the primary physician.
In the usual care group, patients will receive standard inpatient management from their primary care team without additional structured NP-led MDT intervention.
The primary outcome is the GDMT implementation rate at hospital discharge, calculated as the number of GDMT drugs prescribed divided by the number indicated according to guidelines. Secondary outcomes include all-cause readmission, emergency department visits, and mortality at 30, 60, and 90 days post-discharge, as well as selected disease-specific clinical indicators when available (e.g., left ventricular ejection fraction, HbA1c, blood pressure, LDL-C, eGFR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age: 18 years or older
- •Admitted to the multidisciplinary ward through the emergency department for inpatient care
- •Diagnosed with at least one of the following six chronic conditions and concurrently having one or more additional chronic diseases:
- •Congestive Heart Failure (CHF)
- •Diabetes Mellitus (DM)
- •Hypertension (HTN)
- •Dyslipidemia (DLP)
- •Atrial Fibrillation (AF)
- •Chronic Kidney Disease (CKD)
排除标准
- •End-of-life (EOL) patients: Refers to patients receiving palliative care or those assessed by the medical team as unlikely to survive to discharge during the current hospitalization.
- •Patients expected to be transferred to other departments: For example, patients anticipated to be transferred to oncology, intensive care unit (ICU), surgery, or other departments where full MDT intervention cannot be implemented.
- •Unwilling to participate.
- •Patients under the care of the study team physician on the day of hospitalization.
- •Patients known to be economically or educationally disadvantaged
研究组 & 干预措施
NP-led MDT Intervention Group
Participants receive care from a nurse practitioner-led multidisciplinary team providing individualized, guideline-based medication recommendations.
干预措施: NP-led MDT (Behavioral)
Usual Care Group
Participants receive usual inpatient care from the primary care team without additional NP-led MDT intervention.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
GDMT Implementation Rate at Hospital Discharge
时间窗: On the day of hospital discharge
The proportion of guideline-directed medical therapy (GDMT) drugs prescribed at hospital discharge, calculated as the number of GDMT drug classes prescribed divided by the number of drug classes indicated.
次要结局
未报告次要终点
研究者
National Taiwan University Clinical Trial Center
Principal Investigator
National Taiwan University Hospital
