Basic Care Revisited: Early Nutrition Intervention for Outpatients

Malnutrition Clinical Trial

— BCR_N  

Official title:

Basic Care Revisited: an Early Nursing Nutrition Intervention for Outpatients in Need of Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02440165
• Other study ID #: 2014-1353
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2015
• Last updated: May 6, 2015
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2015
• Source: Radboud University
• Contact: Getty Huisman - de Waal, PhD
• Phone: +31 243619750
• Email: getty.huisman-dewaal[@]radboudumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and DevelopmentNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dietary Modification
• Malnutrition

Intervention

Behavioral:
• Nursing nutrition intervention
The early nursing nutrition intervention will include malnutrition screening (during outpatient clinic visit) with the MUST. If patients are ´at risk for malnutrition´ or ´malnourished´, a standardized nutrition care plan will be discussed with the patient by the nurse. This nutrition care plan will include: Information and advice; Examples of energy and protein rich meals; patients will be asked to register their nutritional intake for two days at home; after a week, the nurse will call the patients to answer questions and to give advice. This nutrition care plan will be tailored to the individual patient requirements. Furthermore, if patients are 'malnourished', a visit to the dietician is always suggested, because this is usual care.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland
Netherlands	Sint Maartenskliniek	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI	body mass index: at 3 points in time; 1) at the outpatient clinic, 2) at hospitalisation, and 3) at discharge. Average time frame for each patient is 5 weeks.	Up to 6 months	No
Secondary	LOS	Length of hospital stay: at discharge	Up to 6 months	No
Secondary	Health related QoL	Health related Quality of life: at discharge	Up to 6 months	No
Secondary	CQ satisfaction	after outpatient clinic visit, and at hospitalisation: Satisfaction in general for 'Nursing care' and specified for nutritional care. This question is derived from the Consumer Quality Index (http://www.centrumklantervaringzorg.nl/publicaties/publicaties-cq-index.html)	Up to 6 months	No
Secondary	Costs	To evaluate costs of the intervention, the reach and delivery data collected for the purpose of process evaluation will be used, and combined with cost estimates for both the intervention and usual care, from the perspective of direct healthcare costs. In the analysis the outcomes of the intervention and care as usual (specific and generic outcomes) will be matched with the costs of implementation, costs of nursing care performed (in euros per hour, observed in 30 patients per group) and costs of training and materials. In this way a first exploration of cost effectiveness will be available.	Up to 6 months	No
Secondary	Process	An adapted version of the Linnan and Steckler framework for conducting process evaluation studies will be used (Linnan and Steckler, 2002, Saunders et al., 2005).	Up to 6 months	No