A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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.
• Other 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.

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

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 of at least 48 hours
• Able to speak and understand Danish
• Able to provide written informed consent

Exclusion criteria

• Terminally ill patients with short expected survival

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07730996 · ADDUCE-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗