- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509116
The Dietetic Consultation: an Illuminative Evaluation
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, SE1 9NH
- King's College London
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient group 2
Qualitative interview, key stakeholders, documentary analysis
|
Qualitative interviews, key stakeholders, documentary analysis
|
|
Patient group 1
Consultation observation, documentary analysis
|
Consultation observations, documentary analysis
|
|
Dietitians
Consulting Dietitians
|
Qualitative interviews, key stakeholders, documentary analysis
Consultation observations, documentary analysis
|
|
Key Stakeholders
Patient-Nominated Key Stakeholders (Relatives/Carers)
|
Qualitative interviews, key stakeholders, documentary analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of 2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietitian AfC Banding
Time Frame: At enrollment.
|
The NHS AfC Banding for consulting dietitians included.
NHS Band 5 = entry level dietitian, NHS Band 6 = more experienced and specialised dietitian, NHS Band 7 = more advanced level dietitian.
Data were collected on the NHS Banding (determined by their employer) for each dietitian included to understand how their experiences differed by seniority.
Data collected for dietitians only.
|
At enrollment.
|
|
Dietitian Speciality
Time Frame: At enrollment
|
Clinical speciality of consulting dietitians included.
Data collected for dietitians only.
|
At enrollment
|
|
Type of Intervention
Time Frame: At enrollment.
|
Type of nutritional support intervention the patient received during dietetic consultation.
Data collected for patients only.
|
At enrollment.
|
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Consultation Type
Time Frame: At enrollment.
|
New (i.e.
new episode of dietetic care) or review/follow-up (had previous consultation in current episode of care) re the dietetic consultation.
Data collected for patients only.
|
At enrollment.
|
|
Family Support
Time Frame: At enrollment.
|
Whether the patient had family support or not at the time of study enrollment.
Data collected for patients only.
|
At enrollment.
|
|
Relationship to Patient
Time Frame: At enrollment.
|
Relationship of key stakeholder to patient.
Data collected for key stakeholders only.
|
At enrollment.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alastair Duncan, PhD, King's College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 184290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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