NCT Number: NCT07730996
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For routinely collected hospital data:
Inclusion criteria
For the prospectively enrolled cohort:
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days, 90 days
Days alive and out of hospital after index admission. Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Time frame: 30 days, 90 days
Assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Time frame: Day 1-4, day 30
Energy intake (kJ/day) expressed as a percentage of estimated energy requirements, assessed in the prospectively recruited cohort of approximately 216 enrolled participants. Energy intake will be estimated using a 24-hour dietary recall conducted as a structured interview with the participant, supported by data from the hospital electronic meal ordering system and the electronic administration records for enteral and parenteral nutrition.
Time frame: Day 1-4, day 30
Protein intake (g/day) expressed as a percentage of estimated protein requirements, assessed in the prospectively recruited cohort of approximately 216 enrolled participants. Protein intake will be estimated using a 24-hour dietary recall conducted as a structured interview with the participant, supported by data from the hospital electronic meal ordering system and the electronic administration records for enteral and parenteral nutrition.
Time frame: Day 1, day 30
Health-related quality of life assessed using the EQ-5D-5L in the prospectively recruited cohort of approximately 216 enrolled participants. The EQ-5D-5L is a self-administered questionnaire that measures health status across five dimensions and includes a health utility index score. Participants may receive assistance from the data collector if needed. Higher index scores indicate better health-related quality of life.
Time frame: Day 1, day 30
Nutritional risk assessed using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) in the prospectively recruited cohort of approximately 216 enrolled participants. The PG-SGA SF is completed by the participant as a self-administered questionnaire, with assistance from the data collector if required to facilitate completion. The questionnaire assesses weight history, food intake, nutrition impact symptoms, and functional capacity. Higher scores indicate greater nutritional risk.
Time frame: Day 1, day 30
Functional independence assessed using the Barthel Index in the prospectively recruited cohort of approximately 216 enrolled participants. The Barthel Index measures independence in activities of daily living, including mobility, transfers, personal hygiene, feeding, dressing, toileting, bathing, and stair climbing with higher scores indicating greater functional independence. Information will be obtained from the electronic patient record or determined by the data collector if not routinely documented.
Time frame: Throughout study completion, an average of 5 days
Proportion of eligible patients who undergo nutritional risk screening during hospital admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Time frame: Throughout study completion, an average of 5 days
Proportion of eligible patients with a documented nutritional care plan during hospital admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Time frame: Throughout study completion, an average of 5 days
Proportion of eligible patients with documented involvement of a clinical dietitian during hospital admission, assessed using routinely collected hospital data from all eligible patients admitted to participating wards during the study period.
Contact information is provided by the study sponsor or research team.
Lone Viggers, RD, MSc.
CONTACT
Marianne Boll Kristensen, RD, PhD
CONTACT
Gødstrup Hospital
Other
Acronym: ADDUCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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