Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries. (INCA)

December 27, 2023 updated by: Changi General Hospital

Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized, Pragmatic Clinical Trial and Economic Evaluation.

Objective:

To evaluate the impact of an individualized nutrition intervention package on pressure injury healing rates, prevention of new pressure injuries, complications, quality of life, and cost-effectiveness in adult on home nursing care with pressure injuries staged II and above in Singapore.

Study Design:

A two-group, non-blinded, randomized, pragmatic clinical trial with a cost-effectiveness analysis.

Location/ Setting:

Community

Participants:

Adults (aged 21 years and above) receiving home nursing care with at least one pressure injury (Stage II, III, IV, or Unstageable).

190 subjects per arm

Intervention:

The intervention group will receive an individualized nutrition intervention package consisting of individualized nutritional supplementation, specialized nutritional education pamphlets, regular dietetic support via home visits or telehealth, and home nursing care by nurses trained in nutrition care.

The control group will receive specialized nutritional educational pamphlets, and home nursing care by nurses trained in nutrition care, with or without nutritional supplementation.

Outcome Measures:

Main outcomes of wound area reduction, and proportion of participants with >40% area reduction at 30 days, 60 days and 90 days. Secondary outcomes include proportion of participants and wounds with increasing severity of PI stages (e.g., stage II to stage III), improvement in Health-Related Quality of Life (HRQOL) and nutritional status, and incidence of wound infections at 30 days, 60 days and 90 days, proportion of participants with complete healing, mortality and unplanned hospital admissions.

Economic Evaluation:

The primary economic outcome will be the incremental cost-effectiveness ratio (ICER) per pressure injury prevented, with a time horizon of 1 year for intervention versus control during the period of intervention (3-months) and up to a year.

Statistical Analyses:

Individual patient level analysis will be performed as per our primary analysis, and we will also perform cluster level analysis. Hazard ratios (HR) will be determined using Cox proportional hazards models and their corresponding 95% Confidence Intervals (95%CI). Imbalances in individual level data will be accounted for using statistical adjustment in a Mixed-Effects Cox Regression model.

Hypothesis:

This study aims to provide evidence on the effectiveness and cost-effectiveness of a individualized and protocolized nutrition intervention package for pressure injury management in home care patients. The findings could inform the development of evidence-based guidelines and recommendations for nutritional care and education in this vulnerable population, ultimately leading to improved patient outcomes and reduced healthcare costs associated with pressure injuries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intervention:

  • Individualized nutritional intervention
  • receive an educational pamphlet on nutritional and wound care for patient/family based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline", with an in-depth explanation by trained nursing staff and research dietitian.
  • reinforcement of nutritional education (adequate calories/ protein/fluid intake, and compliance to consumption of supplements) by nurses on visits without dietitian.
  • A dietetic consultation at baseline, 30 days, 60 days and 90 days of the intervention will be done by an experienced and trained dietitian on optimizing nutritional intake to meet energy/protein requirements. The dietetic consultation will be done via face-to-face home visits and/or teleconsultation (depending on patient and caregiver preference).
  • additional high protein high energy (HPHE) supplementation (commercial ready-to-drink oral nutritional supplements, which are available in hospitals, pharmacies and retail outlets) prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d).
  • a specialized nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding for 12 weeks (14 serves per week).
  • adjustment of enteral feeding regimen will be made for those patients who have not seen a dietitian previously in their last hospital admission.
  • Compliance to supplementation will be determined by recording the amount of leftover products by individuals / caregivers and confirmation of intake with the caregiver / family member during the dietitian or nursing visit at 30-day, 60-day and 90-day period.

Control:

  • protocolized nutritional intervention
  • receive an educational pamphlet on nutritional and wound care for patient/family based on the latest nursing and nutritional guidelines, with an in-depth explanation by trained nursing staff. The trained nurses will provide reinforcement of nutritional education on planned visits as per usual practice over the 90 days.
  • Standard care and follow-up as per hospital care plans with dietitian/home nursing foundation calling hospital dietitian-in-charge of subject if necessary, for verbal advice as per usual practice.
  • HPHE supplementation (commercial standard ready-to-drink oral nutritional supplements available in pharmacy) / dietary advice to meet nutritional requirements will be based on previous recommendations from hospital dietitian-in-charge/clinician review of subject.

Primary Outcome Measurements

  1. Change in Pressure Injury Area from Baseline: Measurement of the alteration in the surface area of the identified pressure injury (PI) at time points of 30, 60, 90 days, 6 months and 1 year post-intervention.
  2. Proportion of Participants with 40% or Greater Area Reduction: Calculation of the percentage of participants who exhibit a reduction in the PI area by at least 40% at the same time points.

Secondary Outcome Measurements

  1. Proportion with Increased Severity in Pressure Injury Stages
  2. Proportion with Complete Pressure Injury Healing
  3. Proportion with Improvement in Health-Related Quality of Life (HRQOL)
  4. Proportion with Nutritional Status Improvement
  5. Change in HRQOL (EQ-5D-5L Utility Values and VAS)
  6. Incidence of New Pressure Injury
  7. Incidence of Pressure Injury Wound Infections
  8. Mortality Rate
  9. Unplanned Hospital Admissions and Length of Stay

Study Type

Interventional

Enrollment (Estimated)

380

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Home Nursing Foundation
        • Contact:
          • Precilla Lai

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

Description

Inclusion Criteria:

  1. Adult (age more than or equal to 21 years, any gender).
  2. Stage II, III, IV, and unstageable pressure injuries. For patients with multiple wounds, we will include all the pressure injuries (stages II and above) in the investigation.
  3. Able to provide written informed consent (patient or legal guardian).
  4. Be on oral and/or enteral nutritional support.

Exclusion Criteria:

  1. Known palliative care individuals with a lifespan of </= 3 months,
  2. Known septicaemia,
  3. Poorly controlled diabetes (glycated haemoglobin level > 8.5%17),

  4. Individuals on strict fluid restriction if the provision of additional oral or enteral nutrition supplements leads to excess intake, for the following conditions:

    1. Advanced renal disease not on dialysis (KDIGO [21, 22] Stage G4 with an estimared Glomerular Filtration Rate (eGFR) of 15-29 ml/min/1.73m2 and Stage G5 with an eGFR less than 15 ml/min/1.73m2
    2. Advanced decompensated alcoholic and non-alcoholic liver cirrhosis
    3. Heart failure with reduced ejection fraction requiring fluid restriction less than 800ml per day,

6. Previous (last chemotherapy or radiotherapy less than one year ago) or current neoplastic disease 7. Currently on immunosuppressive therapy, 8. Known allergy reaction to L-arginine, phenylketonuria 9. Presence of an infected wound (if it is the only pressure injury present on the participant) 10. Presence of untreated diagnosed osteomyelitis.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Individualized and Protocolized Nutrition Care Bundle with Nutritional Supplementation, Education and Support by Nurses trained in Nutritional Management and Dietitians.
Other: Individualized and Protocolized Nutritional Care Bundle
Education on nutritional and wound care for patient/family based on the latest guidelines based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline". A dietetic consultation at baseline, week 4 and week 8 on optimizing nutritional intake to meet caloric/protein requirements, along with additional high protein high energy (HPHE) supplementation prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d). The dietetic consultation will be done via face-to-face home visits and/or telehealth. A specialised nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding (mixed in 100ml water) for 12 weeks.
Experimental: Control
Nursing Care by Nurses trained in Nutritional Management, with or without Supplements.
Other: Optimized Standard Care
Only receiving education and management from specialized nurses trained in nutritional management , with or without supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the area of pressure injury from baseline
Time Frame: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Assessed by the change in wound area from baseline to the follow-up timepoints, measured with a 3D wound imaging device at the time of follow-up.
Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Percentage (%) of participants at time of follow-up with pressure injury wound area reduction of >/=40%
Time Frame: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Percentage (%) of participants at time of follow-up with wound area reduction >/= 40%, at time of follow-up versus baseline, where the number of patients with wound area reduction >/= 40% at follow-up timeframe will be determined as a percentage of total number of participants in the study group.
Baseline, 30 days, 60 days, 90 days, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with complete wound healing of the main wound
Time Frame: 30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with complete wound healing of the main wound. Assessed by the number of participants with complete healing of a wound, determined by clinical assessment and pressure injury staging.
30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with increased severity of pressure injury (PI stage)
Time Frame: 30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with increased severity of pressure injury (PI stage). Assessed by the number of participants with increased severity of wound at follow-up. Severity of pressure injury determined by the increase in pressure injury staging, or increase in area of wound if pressure injury staging remains the same at the follow-up time points
30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with new wound infection
Time Frame: 30 days, 60 days, 90 days, 6 months and 1 year
Proportion of participants with New wound infection. Assessed by the number of participants with a new wound infection(s) at follow-up, that is clinically diagnosed with confirmation from blood tests (e.g., C-Reactive Protein (CRP), renal and liver function tests).
30 days, 60 days, 90 days, 6 months and 1 year
Change in Health-Related Quality of Life (HRQOL) utility scores from baseline to time of follow-up.
Time Frame: 90 days, 6 months and 1 year
Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) utility scores at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences.
90 days, 6 months and 1 year
Change in Health-Related Quality of Life (HRQOL) Visual Analogue Scale (VAS) scores from baseline to time of follow-up.
Time Frame: 90 days, 6 months and 1 year
Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) Visual Analogue Scale (VAS) at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences.
90 days, 6 months and 1 year
Change in Nutritional status.
Time Frame: 30 days, 60 days, 90 days and 1 year
Change in Nutritional status. Assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria, to determine the severity of malnutrition. Change in the nutritional status determined by direction of nutritional status shift from baseline to follow-up.
30 days, 60 days, 90 days and 1 year
Change in Nutritional Intake.
Time Frame: 30 days and 60 days
Change in Nutritional Intake. Assessed by the change in average of energy, protein and selected micronutrient intake derived from 3day food records.
30 days and 60 days
Mortality
Time Frame: 30 days, 60 days, 90 days, 6 months and 1 year
Mortality assessed by the occurrence and time-to-event of all-cause mortality during the study period.
30 days, 60 days, 90 days, 6 months and 1 year
Unplanned Hospital Admission
Time Frame: 30 days, 60 days, 90 days, 6 months and 1 year
Unplanned hospital admission assessed by the occurrence and time-to-event of one or more admissions during the study period.
30 days, 60 days, 90 days, 6 months and 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Nutrition Supplementation Intake
Time Frame: 30 days, 60 days and 90 days
Adherence to nutrition supplementation assessed by the number of participants with >75% consumption of oral nutritional supplements and Arginaid, where the servings of products consumed are counted w confirmation of intake during follow-up.
30 days, 60 days and 90 days
Hospital Length of Stay
Time Frame: 1 year
Hospital Length of Stay assessed by the number of days for each unplanned hospital admission.
1 year
Wound Depth
Time Frame: 30 days, 60 days, 90 days, 6 months and 1 year
Wound Depth measured (millimeters) using sterile forceps and ruler at follow-up.
30 days, 60 days, 90 days, 6 months and 1 year
Wound Duration
Time Frame: 1 year
Measured by days to complete heal for participants with complete wound healing.
1 year

Collaborators and Investigators

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

Sponsor

Changi General Hospital

Collaborators

Duke-NUS Graduate Medical School
Home Nursing Foundation (HNF)
Temasek Foundation

Investigators

  • Principal Investigator: Alvin Wong, MSc, SingHealth Duke NUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 23, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA

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.

Clinical Trials on Wounds and Injuries

Clinical Trials on Individualized and Protocolized Nutritional Care Bundle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe