Clinical trial NCT02440165: Basic Care Revisited: Early Nutrition Intervention for Outpatients
Official title: Basic Care Revisited: an Early Nursing Nutrition Intervention for Outpatients in Need of Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Dietary Modification
Keywords: nutrition
nurse
intervention
malnutrition
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Sint Maartenskliniek
First posted: 2015-05-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Early nursing nutrition intervention for outpatients in need of surgery

* Objective - To investigate the feasibility and effectiveness of screening and an early nursing intervention on malnutrition in outpatients in need for surgery.
* Design - Multi-centre cluster-randomised controlled early trial design (n=150 patients)
* Intervention - Malnutrition screening (during outpatient clinic visit) and (in case of patients being ´at risk for malnutrition´ or being ´malnourished´), a nutrition care plan (including nutritional drinks and energy and protein rich meals) tailored to individual patient requirements
* Comparison - Usual care (no nutritional care plan)

Detailed description: Early screening and treatment of malnutrition is vital. The prevalence of malnutrition at hospital admission has only slightly decreased over the last few years. (Halfens, 2007) This indicates that screening and intervention early in the course of developing disease, e.g. at the outpatient clinic, can prevent severe malnutrition and decrease the amount and complexity of care. (Jonkers-Schuitema et al., 2011; Leistra et al., 2009). Screening for malnutrition and nutrition interventions at the outpatient clinic however, is no daily practice. Leistra et al. (2009) showed that only 17% of the severely undernourished patients and 4% of the moderately undernourished patients received some form of dietetic treatment at the outpatient clinic. Early nursing nutrition interventions have not been studies well before.

Aim: To investigate the feasibility and effectiveness of screening and an early nursing intervention on malnutrition in outpatients in need for surgery.

Design: Multicentre cluster randomized controlled trial design in surgical outpatient clinics in two hospitals (one academic and one non-academic). The intervention is randomly assigned to half of the outpatient clinics, and patients clustered with these nurses, working at the outpatient clinics. The remaining nurses and their patients will serve as a control group. Nursing teams with nurses working in multiple teams will be excluded. Nurses will be trained in the use of the MUST-Screening and nutrition care plans. Study population: Patients visiting the outpatient clinic, planned for operation, of one academic and one non-academic hospital (n=150).

Description of the intervention: The early nursing nutrition intervention will include malnutrition screening (during outpatient clinic visit) with the MUST. If patients in the intervention group are being ´at risk for malnutrition´ or being ´malnourished´, a standardised nutrition care plan (including nutritional drinks and energy and protein rich meals, tailored to individual patient requirements) will be discussed with the patient by nurses. Control patients will receive usual care (no nutrition care plan). The intervention period will be 6 months.

Outcome: Primary: Up to 6 months, BMI will be measured at three point in time: 1) at the outpatient clinic, 2) at hospitalisation, and 3) at discharge. Also, intake of nutrients will be measured for 2 days after the outpatient clinic visit. Average time frame for each patient is 5 weeks, for both intervention and control group.

Secondary: Up to 6 months, Length of Stay (LOS) and health-related quality of life (EQ-5D) will be measured at discharge, and CQ satisfaction with nutritional care \& care in general will be measured at the outpatient clinic and at hospitalisation. Average time frame for each patient is 5 weeks, for both intervention and control group.

To evaluate costs of the intervention, nurses time investment with patients at risk will be observed in 30 patients per group and combined with average costs to arrive at a preliminary cost of usual care and the early nutrition intervention. To evaluate the process, nurses will be interviewed (n=6) to collect data on the manner in which the intervention changes the nursing care.

Statistical analysis: Data will be analysed on an intention-to-treat basis. Results are clustered at ward level. In this study with the same subjects at baseline and follow-up, we will therefore use a linear mixed model for repeated measurements, with ''nurse'' as random effect, BMI as main outcome, and group, time and the group x time interaction as fixed effects.

Eligibility criteria: Inclusion Criteria:

* Patients planned for surgery within 6 weeks after the outpatient clinic visit;
* Patients with an age of 18 years or older;
* Patients with the ability to speak and read the Dutch language.

Exclusion Criteria:

* Hospital admission within one week after the outpatient clinic visit;
* Expected hospital admission \< 5 days.

Primary outcomes:
measure: Change in BMI
timeFrame: Up to 6 months
Secondary outcomes:
measure: LOS
timeFrame: Up to 6 months
measure: Health related QoL
timeFrame: Up to 6 months
measure: CQ satisfaction
timeFrame: Up to 6 months
measure: Costs
timeFrame: Up to 6 months
measure: Process
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Ria Nijhuis- van der Sanden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Noort HHJ, Witteman BJM, Vermeulen H, Huisman-de Waal G; Basic Care Revisited research group. An outpatient nursing nutritional intervention to prehabilitate undernourished patients planned for surgery: A multicentre, cluster-randomised pilot study. Clin Nutr. 2020 Aug;39(8):2420-2427. doi: 10.1016/j.clnu.2019.11.038. Epub 2019 Dec 2.