Postoperative Dietary Intake of Hip Fracture Patients

June 24, 2024 updated by: Helen Lloyd, Teesside University

An Observation Study of Postoperative Dietary Intake of Older Adult Hip Fracture Patients: a Weighed Food Diary

The goal of this observational study is to observe the postoperative dietary intake in older adult hip fracture patients from their day of surgery (day zero) until day three inclusive. The aims of this study are:

Primary aim:

To observe if the postoperative dietary energy intake (kJ/kcal) of older adult hip fracture patients meets Resting Energy Expenditure (REE) needs.

Secondary aims:

To explore if there is a correlation between postoperative dietary intake and length of hospital stay.

To explore the relationship between comorbidity (where reported) and postoperative dietary intake, according to dietary intake.

To explore (if) in the development of postoperative complications (infection, pressure ulcer and VTE), there is a correlation with postoperative dietary intake.

Study Overview

Detailed Description

A hip fracture is one of the most serious injuries that an older adult can sustain and with the current projections from the NHS Long Term Workforce plan of an increase in >85yrs by 55% and a current estimation of over 75,000 hip fractures per year in England, Northern Ireland and Wales with a 6-8% mortality rate at 1 year, this warrants further research to improve outcomes and look at methods beyond the National Hip Fracture Database (NHFD) to ascertain what more can be done to optimise and improve this patient group. Whilst ONS supplementation is used on an ad-hoc basis for patients with a high-risk malnutrition screening score of 2 using the MUST screening method, such tools can lack sensitivity and accuracy and are also not developed to identify the development of malnutrition in-hospital.

The proposed study for this protocol is an observation study of the dietary intake of older adult hip fracture patients. The study will comprise of a weighed food diary, commencing on day zero after surgery. Potential participants that will be invited will be older adult hip fracture patients (>60yrs) with a confirmed hip fracture diagnosis that requires surgical repair. The diary will consist of the researcher weighing the plate of food before and after the participant's meal as this is regarded as a more accurate measure than relying on participant recall and does not place the participant under any additional stress.

The researcher will not handle any food, and plates will be placed on a digital scale. Should a food have a specified weight - for example a yoghurt, the weight on the product will be recorded. Fluid intake will be recorded according to drinks served with meals and jugs of water per day. After each meal the researcher will weigh the plate; if it is a multiple item meal (for example meat, potatoes, and vegetables), the researcher will weigh the leftover components individually to ensure the validity of the weighed food method and to achieve the highest degree of accuracy possible. The researcher will not be present nor disrupt the participant during their meal. After their meal, the researcher will ask the participant if they have had any additional snacks and observe if they have had any assistance with their meal. Data will also be obtained regarding the times of meals, the ratio of staff to patients and if any complications have developed.

The aim of this study is to explore the postoperative dietary intake of older adult hip fracture patients until day three after surgery. This builds on research where data on hip fracture patients was taken in relation to diet, anthropometry, and biochemical indices during inpatient stays. Whilst the study was commenced in the second week post-surgery and compared against values at the week 1 admission as a baseline, the researchers observed a longer length of stay, drops in energy intake that coincided with a low BMI on admission and additionally, referrals for high-risk patients that were not actioned.

Subsequent studies have used varied interventions to explore postoperative nutrition, however a weighed food diary has yet to be used in the immediate postoperative period, which justifies the need for this study to explore nutritional intake as accurately as possible.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Middlesbrough, United Kingdom, TS1 3BX
        • Recruiting
        • Teesside University
        • Contact:
        • Principal Investigator:
          • Helen Lloyd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prospective older adult hip fracture patients aged 60 and over at the point of admission.

Description

Inclusion Criteria:

  • Adults >60yrs with a confirmed diagnosis of a hip fracture requiring surgical repair.

Exclusion Criteria:

  • Pathological hip fractures
  • Traumatic hip fractures - such as a road traffic collision injury.
  • Patients that cannot speak English due to the need for informed consent.
  • Patients undergoing oncologic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative dietary energy intake (kJ/kcal) of older adult hip fracture patients meets Resting Energy Expenditure (REE) needs.
Time Frame: 3 days
REE in kJ/kcal
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Correlation between comorbidity (where reported) and postoperative dietary intake, according to dietary intake.
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Correlation between comorbidity and dietary intake
From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Correlation between Postoperative complications (infection, pressure ulcer and VTE), and postoperative dietary intake.
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Link between complications and dietary intake
From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Postoperative dietary intake
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
From day of surgery until discharge from acute hospital stay, assessed up to 3 months
The length of hospital stay.
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
From day of surgery until discharge from acute hospital stay, assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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