A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)

NCT07730996 | Not Yet Recruiting

• 1 other identifier: ADDUCE-2026
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hospitalized Adult Patients; Inpatient Internal Medicine Patients; Haematologic Disease; Pulmonary Diseases; Infectious Diseases; Gastroenterology; Renal Diseases

Keywords

Disease-related malnutrition; Nutritional risk; Nutritional care; Clinical dietitian; Nutritional risk screening; Medical inpatients; Health services research; Interdisciplinary care; Hospital nutrition; Nutrition; Stepped-wedge cluster randomised trial

Outcome Measures

Primary Outcomes (2)

• Length of hospital stay

  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.

  Through study completion, an average of 5 days

• Hospital re-admissions

  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.

  30 days, 90 days

Secondary Outcomes (10)

• 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

Study Arms (2)

Dietitian-driven nutritional care model

EXPERIMENTAL

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.

Behavioral: Dietitian-driven nutritional care model

Current practice

ACTIVE COMPARATOR

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.

Other: Current practice nutritional care

Interventions

Dietitian-driven nutritional care model BEHAVIORAL

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.

Dietitian-driven nutritional care model

Current practice nutritional care OTHER

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.

Current practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• Terminally ill patients with short expected survival

Sponsors & Collaborators

• Gødstrup Hospital: lead
• The Danish Dietetic Association: collaborator
• NIDO Research Foundation: collaborator
• Health Research Foundation of Central Denmark Region: collaborator

MeSH Terms

Conditions

Hematologic Diseases; Lung Diseases; Communicable Diseases; Kidney Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Respiratory Tract Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marianne Boll Kristensen, RD, PhD

  Department of Nutrition, Gødstrup Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Boll Kristensen, RD, PhD

CONTACT

+4581441015; maboki@rm.dk

Lone Viggers, RD, MSc.

CONTACT

+4578434500; lonvig@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a stepped-wedge cluster-randomised design. Three medical wards are randomised to the order in which they transition from current practice to the intervention. All wards begin in the control condition and sequentially cross over to the intervention condition at predefined time points until all wards have implemented the intervention.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): May 16, 2027
• Study Completion (Estimated): May 16, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share