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The Dietetic Consultation: an Illuminative Evaluation

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ClinicalTrials.gov Identifier: NCT03509116
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief Summary:

This study aims to understand the experience of the dietetic consultation from the perspective of nutritionally vulnerable older patients receiving oral nutrition support and dietitians, as well as other key stakeholders involved in the process of such a consultation.

Malnutrition is prevalent and increases the risk of health complications and socioeconomic burden. Patients with malnutrition are often older patients with complex needs and therefore may require specialist knowledge and skills to provide nutritional support. Dietitians are uniquely skilled to assess the multiple factors that underpin diet and to tailor nutritional support, which could help improve outcomes. Although the causes of malnutrition are complicated, its treatment typically involves oral nutritional supplements, dietary advice or food-based interventions, either separately or in combination.

Effectiveness of the various oral nutritional support interventions has been studied, with the findings on food-based interventions suggesting more research is needed and the widespread research on ONS suggesting contradictory results and interpretations. Despite this, the factors responsible for these inconsistencies have not been identified. There are no studies so far that have examined the patient experience of the consultation with the dietitian in the context of nutritional support. Although the patient experience of consultations is increasingly being recognised as an important part of investigating their effectiveness in healthcare, to date, there are a number of limitations in this literature, leaving the role of the patient experience in dietetic consultations for the management of malnutrition, poorly understood. It's probable that this is one contributing factor to the variation observed in the literature.

A review of the literature indicates a need for exploration of the patient experience and its possible impact on the success or failure of the dietetic encounter. This study aims to address some of the knowledge gaps. The use of qualitative interviews will allow an in-depth understanding of the experience of the dietetic consultation for the provision of nutrition support and will utilise an overall illuminative evaluation approach to broaden that understanding by considering data from various sources. Participants will include older patients who are considered nutritionally vulnerable, their consulting dietitians and patient-nominated key stakeholders. Four clinical settings within the Trust where dietitians would often see patients for nutritional support will be included.


Condition or disease Intervention/treatment
Malnutrition Other: Observations Other: Interviews, key stakeholders, documents

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
Official Title: Understanding the Experience of the Dietetic Consultation and the Perceptions of Its Value From the Perspective of Nutritionally Vulnerable Older Patients, Dietitians and Other Key Stakeholders: an Illuminative Evaluation
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : December 28, 2019
Estimated Study Completion Date : December 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort Intervention/treatment
Patient group 1
Observations only
Other: Observations
Consultation observations

Patient group 2
Qualitative interview, key stakeholders, documentary analysis
Other: Interviews, key stakeholders, documents
Qualitative interviews, key stakeholders, documentary analysis




Primary Outcome Measures :
  1. The experience of the dietetic consultation (Qualitative Outcome) [ Time Frame: 23 months ]
    Themes and sub-themes generated from qualitative data collected from direct observations of dietetic consultations, semi-structured qualitative interviews, analysis of relevant documents pertaining to the dietetic consultation.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients:

Older patients malnourished or at risk of malnutrition requiring oral nutritional support from a dietitian in a range of clinical settings.

Dietitians:

Consulting registered dietitian providing the nutritional advice to patient above

Key Stakeholders:

Up to 2 optional patient-nominated key stakeholders who are involved in the dietetic consultation and success of the dietetic intervention e.g. other HCP, carer or family member.

Criteria

Inclusion Criteria:

Patients:

  • Adults (aged > 60 years)
  • National Health Service (NHS) number
  • Capable of giving informed consent
  • Able to communicate well in English
  • Nutritionally vulnerable according to the Nutrition Screening Tool in use at the NHS Trust prompting referral to a dietitian
  • Likely to receive a form of oral nutrition support in the management of malnutrition
  • A variety of the patient characteristics detailed earlier will be included where possible
  • Consents to having their qualitative interview audio-recorded (Group 2)

Dietitians:

  • Consulting dietitian providing the nutritional advice to patient above
  • Employee of the NHS Trust and member of the Nutrition & Dietetic team
  • Minimum of three different dietitians across the healthcare settings to be included
  • Consents to having their qualitative interview audio-recorded

Key Stakeholders:

Up to 2 optional patient-nominated key stakeholders who are involved in the dietetic consultation and success of the dietetic intervention e.g. other HCP, family member, carer or friend. Their criteria for inclusion will include:

  • Nominated by the patient (from Group 2) participating in the study
  • Involved in some aspect of the implementation of goals agreed between the patient and dietitian during the consultation i.e. the nutritional intervention
  • Available for separate interview at a mutually agreed location
  • Capable of giving informed consent
  • Able to communicate well in English
  • Consents to having their qualitative interview audio-recorded

Exclusion Criteria:

Patients:

  • Participated or due to participate in another aspect of the study i.e. a patient will not be recruited to participate in consultation observations if they have already been or due to be recruited to take part in the qualitative interviews and vice versa.
  • Outside of stated age range for inclusion
  • Incapable of giving informed consent
  • No National Health Service (NHS) number
  • Unable to communicate well in English
  • Not considered nutritionally vulnerable according to Nutrition Screening Tool
  • Not referred to a dietitian for nutrition support
  • Patients receiving artificial nutrition support
  • Does not wish to have their qualitative interview audio-recorded (Group 2)

Participants with visual or hearing impairment or other physical disabilities will NOT be excluded from the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509116


Contacts
Contact: Michelle Gibbs, PhD student +44 7376555247 michelle.gibbs@kcl.ac.uk

Locations
United Kingdom
King's College London Recruiting
London, United Kingdom, SE1 9NH
Contact: Michelle Gibbs, PhD student       michelle.gibbs@kcl.ac.uk   
Principal Investigator: Christine Baldwin, PhD         
Sub-Investigator: Peter Emery, PhD         
Sub-Investigator: Elizabeth Weekes, PhD         
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Christine Baldwin King's College London

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03509116     History of Changes
Other Study ID Numbers: 184290
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King's College London:
patient experience
disease-related malnutrition
nutritional care
dietetic consultation
older adults
oral nutritional support

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders