A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Dietitian-driven nutritional care model
  Clinical dietitians are integrated into the ward team and assume primary responsibility for systematic nutritional risk screening, nutritional assessment, nutritional care planning, follow-up, and nutritional treatment. Dietitians identify patients requiring nutritional care without waiting for referral and collaborate with nursing staff and other clinicians to provide coordinated nutritional care during hospital admission.
• Другое Current practice nutritional care
  Nutritional care delivered according to existing ward procedures, with nursing staff primarily responsible for nutritional risk screening and nutritional care planning and clinical dietitians involved following referral or consultation.

Первичные конечные точки

• Length of hospital stay [Срок оценки: Through study completion, an average of 5 days]
• Hospital re-admissions [Срок оценки: 30 days, 90 days]

Вторичные конечные точки (10)

• Days alive and out of hospital [Срок оценки: 30 days, 90 days]
• Mortality [Срок оценки: 30 days, 90 days]
• Daily energy intake [Срок оценки: Day 1-4, day 30]
• Daily protein intake [Срок оценки: Day 1-4, day 30]
• Health-related quality of life (EQ-5D-5L) [Срок оценки: Day 1, day 30]
• Nutritional risk [Срок оценки: Day 1, day 30]
• Functional independence [Срок оценки: Day 1, day 30]
• Nutritional risk screening completed [Срок оценки: Throughout study completion, an average of 5 days]
• Nutritional care plan documented [Срок оценки: Throughout study completion, an average of 5 days]
• Clinical dietitian involvement [Срок оценки: Throughout study completion, an average of 5 days]

Критерии участия

For routinely collected hospital data:

Критерии включения

• 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:

Критерии включения

• Age 18 years or older
• Newly admitted
• Expected hospital stay of at least 48 hours
• Able to speak and understand Danish
• Able to provide written informed consent

Критерии исключения

• Terminally ill patients with short expected survival

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07730996 · ADDUCE-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗