Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078488
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-07-31
Brief Title:
Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized Pragmatic Clinical Trial and Economic Evaluation
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCA
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 eg 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 95CI 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
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 eg 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 95CI 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 patientfamily 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 UlcersInjuries 2019 Clinical Practice Guideline with an in-depth explanation by trained nursing staff and research dietitian
reinforcement of nutritional education adequate calories proteinfluid 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 energyprotein requirements The dietetic consultation will be done via face-to-face home visits andor 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 25-35kcalkgd and 12-20g proteinkgd
a specialized nutritional supplement containing 45 g Arginine 156 mg Vitamin C 409 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 patientfamily 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 dietitianhome 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-chargeclinician 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
Individualized nutritional intervention
receive an educational pamphlet on nutritional and wound care for patientfamily 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 UlcersInjuries 2019 Clinical Practice Guideline with an in-depth explanation by trained nursing staff and research dietitian
reinforcement of nutritional education adequate calories proteinfluid 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 energyprotein requirements The dietetic consultation will be done via face-to-face home visits andor 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 25-35kcalkgd and 12-20g proteinkgd
a specialized nutritional supplement containing 45 g Arginine 156 mg Vitamin C 409 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 patientfamily 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 dietitianhome 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-chargeclinician 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None