MalnutritionNCT03509116
The Dietetic Consultation: an Illuminative Evaluation
An observational study of Malnutrition, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Observations, documents and Interviews, key stakeholders, documents
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2018to 31 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Malnutrition
- Being tested
- Observations, documents, Interviews, key stakeholders, documents
- Keywords
- patient experience, disease-related malnutrition, nutritional care, dietetic consultation, older adults, oral nutritional support
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observations, documentsOther
Consultation observations, documentary analysis
Interviews, key stakeholders, documentsOther
Qualitative interviews, key stakeholders, documentary analysis
| Study group | Role | What they receive |
|---|---|---|
| Patient group 1 | Consultation observation, documentary analysis Receives: Other: Observations, documents | |
| Patient group 2 | Qualitative interview, key stakeholders, documentary analysis Receives: Other: Interviews, key stakeholders, documents | |
| Dietitians | Consulting Dietitians Receives: Other: Observations, documents; Other: Interviews, key stakeholders, documents | |
| Key Stakeholders | Patient-Nominated Key Stakeholders (Relatives/Carers) Receives: Other: Interviews, key stakeholders, documents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start16 Mar 2018
- Primary completion12 Dec 2019
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alastair Duncan, PhD, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509116
- Sponsor's protocol ID
- 184290
- Status last verified
- Dec 2024
- First submitted
- 16 Apr 2018
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03509116
- Acronym / sponsor ID
- 184290
- Conditions
- Malnutrition
- Keywords
- patient experience, disease-related malnutrition, nutritional care, dietetic consultation, older adults, oral nutritional support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient group 1 | – | Other: Observations, documentsConsultation observation, documentary analysis |
| Patient group 2 | – | Other: Interviews, key stakeholders, documentsQualitative interview, key stakeholders, documentary analysis |
| Dietitians | – | Other: Observations, documents, Other: Interviews, key stakeholders, documentsConsulting Dietitians |
| Key Stakeholders | – | Other: Interviews, key stakeholders, documentsPatient-Nominated Key Stakeholders (Relatives/Carers) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observations, documentsConsultation observations, documentary analysis | Other | Dietitians, Patient group 1 |
| Interviews, key stakeholders, documentsQualitative interviews, key stakeholders, documentary analysis | Other | Dietitians, Key Stakeholders, Patient group 2 |
Primary outcome
Experience of the Dietetic Consultation (Number of Participants With Dietetic Consultation Experience That Relate to Each Theme)
Time frame: Through study completion, an average of 2 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alastair Duncan, PhD study chair
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by King's College London at 1 site in United Kingdom.
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 22 inclusion and 11 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: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of the Dietetic Consultation (Number of Participants With Dietetic Consultation Experience That Relate to Each Theme) (time frame: Through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2025.