Basic Care Revisited: Early Nutrition Intervention for Outpatients

NCT ID: NCT02440165

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Malnutrition; Dietary Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental

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.

Group Type: EXPERIMENTAL

Nursing nutrition intervention

Intervention Type: BEHAVIORAL

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.

Usual care

All participants, both in the intervention group and the control group, receive usual care containing a regular visit to a nurse who will perform a malnutrition screening with the MUST (Malnutrition Universal Screening Tool). If patients are 'malnourished', a visit to the dietician is suggested.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sint Maartenskliniek

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ria Nijhuis- van der Sanden, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Sint Maartenskliniek

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status: COMPLETED

Countries

Netherlands

Central Contacts

Getty Huisman - de Waal, PhD

Role: CONTACT

getty.huisman-dewaal@radboudumc.nl

+31 243619750

Maud Heinen, PhD

Role: CONTACT

maud.heinen@radboudumc.nl

+31 24 3619750

Facility Contacts

Petra Heesterbeek, PhD

Role: primary

p.heesterbeek@maartenskliniek.nl

+31 24 3659628

References

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.

Reference Type: DERIVED

PMID: 31879076 (View on PubMed)

Other Identifiers

2014-1353

Identifier Type: -

Identifier Source: org_study_id