Clinical trial NCT06078488: Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries.
Official title: Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized, Pragmatic Clinical Trial and Economic Evaluation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wounds and Injuries
Malnutrition
Nutritional Deficiency
Wound Healing Delayed
Nurse's Role
Keywords: Pressure Injury
Nutritional Support
Community Nursing
Clinical Nutrition
Malnutrition
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Home Nursing Foundation (HNF)
name: Duke-NUS Graduate Medical School
name: Temasek Foundation
First posted: 2023-10-11
Enrollment: 380
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the area of pressure injury from baseline
timeFrame: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
measure: Percentage (%) of participants at time of follow-up with pressure injury wound area reduction of >/=40%
timeFrame: Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Secondary outcomes:
measure: Proportion of participants with complete wound healing of the main wound
timeFrame: 30 days, 60 days, 90 days, 6 months and 1 year
measure: Proportion of participants with increased severity of pressure injury (PI stage)
timeFrame: 30 days, 60 days, 90 days, 6 months and 1 year
measure: Proportion of participants with new wound infection
timeFrame: 30 days, 60 days, 90 days, 6 months and 1 year
measure: Change in Health-Related Quality of Life (HRQOL) utility scores from baseline to time of follow-up.
timeFrame: 90 days, 6 months and 1 year
measure: Change in Health-Related Quality of Life (HRQOL) Visual Analogue Scale (VAS) scores from baseline to time of follow-up.
timeFrame: 90 days, 6 months and 1 year
measure: Change in Nutritional status.
timeFrame: 30 days, 60 days, 90 days and 1 year
measure: Change in Nutritional Intake.
timeFrame: 30 days and 60 days
measure: Mortality
timeFrame: 30 days, 60 days, 90 days, 6 months and 1 year
measure: Unplanned Hospital Admission
timeFrame: 30 days, 60 days, 90 days, 6 months and 1 year
Other outcomes:
measure: Adherence to Nutrition Supplementation Intake
timeFrame: 30 days, 60 days and 90 days
measure: Hospital Length of Stay
timeFrame: 1 year
measure: Wound Depth
timeFrame: 30 days, 60 days, 90 days, 6 months and 1 year
measure: Wound Duration
timeFrame: 1 year
Locations:
city: Singapore
country: Singapore
facility: Home Nursing Foundation
Study officials:
affiliation: SingHealth Duke NUS
name: Alvin Wong, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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