NCT03509116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

April 16, 2018

Results QC Date

August 1, 2023

Last Update Submit

January 3, 2025

Conditions

Keywords

patient experiencedisease-related malnutritionnutritional caredietetic consultationolder adultsoral nutritional support

Outcome Measures

Primary Outcomes (1)

  • Experience of the Dietetic Consultation (Number of Participants With Dietetic Consultation Experience That Relate to Each Theme)

    Themes and sub-themes related to the patient experience, dietitian experience and key stakeholder experience of the consultation. These were derived from qualitative thematic analysis of triangulated data from interviews, consultation observations and consultation documents derived from ALL study participants (n=39). Final themes included: 1. Building a therapeutic alliance 2. Navigating changes beyond the consultation 3. Dynamics of expectations, power and satisfaction 4. Influences and realities of professional practice. Please note that ALL study participants (n=39) from all 4 groups (Patient Group 1, Patient Group 2, Dietitians, and Key Stakeholders) contributed to all 4 final constructed themes noted above as all data were qualitatively triangulated. These 4 themes represent how the dietetic consultation was experienced from multiple perspectives, in different contexts and highlighted key areas of the dietetic encounter that mattered to participants.

    Through study completion, an average of 2 months

Other Outcomes (6)

  • Dietitian AfC Banding

    At enrollment.

  • Dietitian Speciality

    At enrollment

  • Type of Intervention

    At enrollment.

  • +3 more other outcomes

Study Arms (4)

Patient group 1

Consultation observation, documentary analysis

Other: Observations, documents

Patient group 2

Qualitative interview, key stakeholders, documentary analysis

Other: Interviews, key stakeholders, documents

Dietitians

Consulting Dietitians

Other: Observations, documentsOther: Interviews, key stakeholders, documents

Key Stakeholders

Patient-Nominated Key Stakeholders (Relatives/Carers)

Other: Interviews, key stakeholders, documents

Interventions

Consultation observations, documentary analysis

DietitiansPatient group 1

Qualitative interviews, key stakeholders, documentary analysis

DietitiansKey StakeholdersPatient group 2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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:
  • +6 more criteria

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Watchful WaitingInterviews as Topic

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr Alastair Duncan
Organization
Guy's & St Thomas' NHS Foundation Trust

Study Officials

  • Alastair Duncan, PhD

    King's College London

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 26, 2018

Study Start

March 16, 2018

Primary Completion

December 12, 2019

Study Completion

July 31, 2022

Last Updated

January 9, 2025

Results First Posted

January 9, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations