A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
The goal of this clinical trial is to learn whether a new way of organising hospital nutrition care can improve outcomes for adults who are admitted to medical wards and are at risk of malnutrition.
The main questions it aims to answer are:
- Does having clinical dietitians take primary responsibility for nutrition care shorten hospital stay?
- Does this approach improve nutritional intake, nutritional status, quality of life, and patient satisfaction?
- Does this approach lower healthcare costs compared with current practice?
Researchers will compare the new nutrition care model with current practice. In current practice, nursing staff are mainly responsible for nutrition screening and nutrition care planning, while clinical dietitians are involved only when requested. In the new model, clinical dietitians are part of the ward team and take primary responsibility for identifying patients at nutritional risk, planning nutritional care, and providing nutritional treatment.
Participants will:
- Receive either the current nutrition care approach or the new dietitian-led nutrition care approach, depending on when they are admitted to the ward
- Complete questionnaires about their nutritional status, quality of life, and daily activities during their hospital stay and about 30 days later
- Have information collected during their hospital stay and from their medical records, including nutritional intake, body weight, length of hospital stay, hospital readmissions, and other health outcomes
The study will be conducted on three medical wards at Gødstrup Hospital. All wards will start with current practice and will gradually change to the new nutrition care model during the study period. Researchers will compare outcomes before and after the new model is introduced.
详细描述
Disease-related malnutrition is common among hospitalised medical patients and is associated with prolonged hospital stay, poorer clinical outcomes, reduced quality of life, and increased healthcare costs. Although evidence-based guidelines recommend systematic nutritional risk screening and nutritional treatment, implementation in routine clinical practice remains inconsistent. In many healthcare systems, including Denmark, responsibility for nutritional risk screening and nutritional care planning is primarily assigned to nursing staff, while clinical dietitians are typically involved only following referral.
The ADDUCE trial (A Dietitian-Driven Unified Nutritional Care Model) evaluates an alternative organisational model for delivering hospital nutritional care. The intervention is based on systematic integration of clinical dietitians into ward teams, with dietitians assuming primary responsibility for nutritional risk screening, nutritional assessment, nutritional care planning, and individualised nutritional treatment in close collaboration with nursing staff. Dietitians are present on the wards daily, participate in routine ward activities, and proactively identify patients requiring nutritional care rather than relying solely on referrals.
The study uses a stepped-wedge cluster-randomised controlled design conducted across three medical wards at Gødstrup Hospital, Denmark. All participating wards begin in the control condition, representing current clinical practice. The intervention is then introduced sequentially across wards in a randomised order until all wards have implemented the dietitian-driven model. This design allows each ward to contribute data under both control and intervention conditions while facilitating implementation at ward level.
Approximately 216 participants will be prospectively recruited and enrolled for detailed data collection, including nutritional intake, body weight, nutritional status, quality of life, patient satisfaction, and other clinical and patient-reported outcomes. In addition, routinely collected hospital data from all eligible patients admitted to participating wards during the study period will be used to evaluate length of hospital stay and hospital readmissions. The enrolled cohort will provide detailed clinical information that supports adjusted analyses of secondary outcomes.
The purpose of the study is to determine whether a dietitian-driven model of nutritional care can improve patient outcomes and healthcare efficiency compared with current practice. The study also aims to evaluate whether earlier identification and treatment of patients at nutritional risk can contribute to more systematic nutritional care in hospital settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
This is an open-label study. Owing to the organisational nature of the intervention, participants and clinicians cannot be blinded. Statistical analyses will be performed using masked group allocation, and interpretation of the primary results will occur before unblinding.
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
- •For routinely collected hospital data:
- •Inclusion Criteria:
- •Age 18 years or older
- •Admitted to a participating medical ward during the study period
- •First eligible admission during the study period
- •For the prospectively enrolled cohort:
- •Inclusion Criteria:
- •Age 18 years or older
- •Newly admitted
- •Expected hospital stay until at least day 3 after admission
- •Able to speak and understand Danish
- •Able to provide written informed consent
排除标准
- •Terminally ill patients with short expected survival
- •Patients admitted to an isolation room at the time of recruitment
研究组 & 干预措施
Dietitian-driven nutritional care model
Clinical dietitians are integrated into the ward team and assume primary responsibility for nutritional risk screening, nutritional care planning, follow-up, and nutritional treatment. Nutritional care is delivered in close collaboration with nursing staff according to a predefined model of care.
干预措施: Dietitian-driven nutritional care model (Behavioral)
Current practice
Nutritional risk screening and nutritional care are delivered according to existing ward procedures. Nursing staff are primarily responsible for nutritional risk screening and nutritional care, while clinical dietitians are involved following referral or consultation as needed.
干预措施: Current practice nutritional care (Other)
结局指标
主要结局
Length of hospital stay
时间窗: Through study completion, an average of 5 days
Length of hospital stay, defined as the time from hospital admission to hospital discharge. Length of stay will be calculated in hours from electronic health record time stamps and expressed in days (hours/24). Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Hospital re-admissions
时间窗: 30 days, 90 days
Number of hospital readmissions after discharge from the index admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
次要结局
- Days alive and out of hospital(30 days, 90 days)
- Mortality(30 days, 90 days)
- Daily energy intake(Day 1-4, day 30)
- Daily protein intake(Day 1-4, day 30)
- Health-related quality of life (EQ-5D-5L)(Day 1, day 30)
- Nutritional risk(Day 1, day 30)
- Functional independence(Day 1, day 30)
- Nutritional risk screening completed(Throughout study completion, an average of 5 days)
- Nutritional care plan documented(Throughout study completion, an average of 5 days)
- Clinical dietitian involvement(Throughout study completion, an average of 5 days)
- Daily energy intake(Day 1-3)
- Daily protein intake(Day 1-3)
- Health-related quality of life (EQ-5D-5L)(Day 2, day 30)
- Nutritional risk(Day 2, day 30)