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MalnutritionBCR_NNCT02440165

Basic Care Revisited: Early Nutrition Intervention for Outpatients

A study testing Nursing nutrition intervention in people with Malnutrition and Dietary Modification, run by Radboud University Medical Center at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Malnutrition, Dietary Modification
What is being tested?
Nursing nutrition intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesNetherlands
Study dates
Jan 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Getty Huisman - de Waal, PhD contact

+31 243619750

getty.huisman-dewaal@radboudumc.nl

Netherlands2 sites, 1 recruiting
  • Sint Maartenskliniek

    Nijmegen, Gelderland, 6500 GM

    Petra Heesterbeek, PhD, +31 24 3659628, p.heesterbeek@maartenskliniek.nl

    Recruiting
  • Radboudumc

    Nijmegen, Gelderland, 6500 HB

    Completed

Other trials in Netherlands

About this study

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

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)
Read the 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.

Being tested
Nursing nutrition intervention
Keywords
nutrition, nurse, intervention, malnutrition
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing nutrition interventionBehavioural

    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.

Study groups in NCT02440165
Study groupRoleWhat they receive
ExperimentalExperimentalThe 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.
Receives: Behavioral: Nursing nutrition intervention
Usual careNo interventionAll 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 months

Secondary outcomes (5)
  1. LOS

    Length of hospital stay: at discharge

    Measured: Up to 6 months

  2. Health related QoL

    Health related Quality of life: at discharge

    Measured: Up to 6 months

  3. 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)

    Measured: Up to 6 months

  4. 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.

    Measured: Up to 6 months

  5. 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).

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2015 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440165
Sponsor's protocol ID
2014-1353
Acronym
BCR_N
Status last verified
May 2015
First submitted
11 Mar 2015
Last updated
12 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31879076

Questions about this trial

What is this clinical trial studying?

A study testing Nursing nutrition intervention in people with Malnutrition and Dietary Modification, run by Radboud University Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Getty Huisman - de Waal, PhD (+31 243619750, getty.huisman-dewaal@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BMI (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02440165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.

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