Nutrition is an important factor for general health and poor nutritional status leads to impaired immune system, also increases the risk for loss of muscle and bone mass, in turn increases the risk for falls and fractures, ultimately lower the capacity for independent living. Malnutrition affects the older and sickest individuals living in the community most. Nutritional interventions such as oral nutritional supplements (ONS) have been found to be effective in addressing the needs of at-risk or malnourished adults by increasing energy, protein intakes and body weight and reducing hospital readmissions and healthcare costs in older adults, thereby reducing the clinical and economic burden. In addition to protein intake as one of the key factors for muscle protein synthesis to support muscle health, β-hydroxy-β-methylbutyrate (HMB) is another important nutrient promoting metabolic activity to counteract muscle loss for older adults and various diseases states.
Given the limited evidence on the effects of HMB supplementation in community-dwelling adults, we aim to conduct a retrospective analysis of adults 18 years and older at-risk or malnourished and assess the utilisation rate and characteristics of individuals with and without various ONS interventions.
Therefore, the study aims to highlight that managing malnutrition could significantly reduce healthcare use, with a positive budget impact, in older malnourished patients in primary care. Nutrition care can also reduce visits to healthcare providers, lower the frequency of emergency department (ED) visits, and shorten the length of stay when hospitalisation is needed.
This is a retrospective cohort study using primary care records (Clinical Practice Research Datalink ) linked with secondary care data (Hospital Episode Statistics) in England. Adults 18 years and older at-risk of malnutrition or malnourished will be included with the utilisation rate and characteristics of individuals that use 1) high protein (HP) oral nutritional supplements (ONS) with β-hydroxy-β-methylbutyrate (HMB), 2) use HP ONS without HMB, 3) use standard ONS and 4) those that don’t use ONS. The study period will be from 1st January 2015 until the most recent linked data available.
The study includes analyses of the incidence of malnutrition or at risk of malnutrition, patients’ demographics and clinical characteristics, healthcare resource use (HCRU) and associated costs over three intervals at 3, 6, 12 months before and after initial diagnosis of malnutrition or being at risk of malnutrition.
Patient demographics and clinical characteristics of interest will be assessed and reported on. Healthcare resource utilisation rates and costs of interest are primary care visits, poly-medication prescriptions, (re)hospital visits (inpatient and outpatient), length of elective inpatient admissions, length of non-elective inpatient admissions and emergency department visits. HCRU and associated costs will be calculated using NHS reference tariffs for secondary care events and GP consultation cost data for primary visits. For each of the three intervals, the propensity-adjusted average treatment effect (ATE) will be calculated. A multiple propensity score will be used to account for baseline differences between treatment groups. The ATE will be the difference-in-differences (DID) between each treatment of interest relative to HP ONS with HMB with statistically significant DIDs.
This study aims to highlight that managing malnutrition could benefit patients of malnutrition through improved health care outcomes reducing visits to healthcare providers, lower the frequency of emergency department visits, and shorten the length of stay when hospitalisation is needed.
Age at index date; gender; ethnicity; geographical region; smoking history; alcohol use; Body Mass Index (BMI); comorbidities of interest (stroke, depression, colorectal cancer, breast cancer, dementia, musculoskeletal disorders and menopause); Charlson Comorbidity Index (CCI); Index of Multiple Deprivation (IMD);
Utilisation rates of primary care visits (GP and nurse visits); utilisation rates of poly-medication prescriptions; utilisation rates of (re)hospital visits (inpatient and outpatient); length of elective inpatient admissions; length of non-elective inpatient admissions; utilisation rates of emergency department (A&E) visits; costs of primary care visits (GP and nurse visits); costs of (re)hospital visits (inpatient and outpatient); costs of emergency department (A&E) visits.
Following analysis Primary objective 3 and Secondary objective 1 have been updated to reflect that propensity adjusted difference in difference will be replaced with exact matched difference in difference.
4. To compare absolute and exact matched difference-in-differences associated with all-cause healthcare utilization (HCRU) in 0-3, 0-6, 0-12 months before compared to 0-3, 0-6, and 0-12 months after index event, among community-dwelling adults at malnutrition risk or malnourished in the following settings:
a. Primary care visits (GP and nurse visits)
b. Poly-medication prescriptions
c. (Re)Hospital visits
o Inpatient admissions (including length of stay)
o Outpatient visits
d. Emergency department (A&E) visits
For the following treatment groups:
• HP ONS with HMB vs HP ONS without HMB
• HP ONS with HMB vs standard ONS
• HP ONS with HMB vs no ONS
• Any ONS (HP ONS with HMB, HP ONS without HMB, standard ONS) vs no ONS
Secondary objectives:
2. To estimate the absolute costs and exact matched difference-in-differences associated with all-cause HCRU in 0-3, 0-6, 0-12 months before compared to 0-3, 0-6, and 0-12 months after index event, among community-dwelling adults at malnutrition risk or malnourished in the following settings:
a. Primary care visits (GP and nurse visits)
b. (Re)Hospital visits
o Inpatient admissions
o Outpatient visits
c. Emergency department (A&E) visits
For the following treatment groups:
• HP ONS with HMB vs HP ONS without HMB
• HP ONS with HMB vs standard ONS
• HP ONS with HMB vs no ONS
• Any ONS (HP ONS with HMB, HP ONS without HMB, standard ONS) vs no ONS
Sophia Fleming - Chief Investigator - IQVIA Ltd ( UK )
Maedeh Yakhchi Beykloo - Corresponding Applicant - IQVIA Ltd ( UK )
Briana Coles - Collaborator - IQVIA Ltd ( UK )
GIANLUCA LUCREZI - Collaborator - IQVIA Solutions Italy S.r.l
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )
Rachel Armstrong - Collaborator - IQVIA - UK
Tarana Mehdikhanova - Collaborator - IQVIA Ltd ( UK )
Xiaohui Sun - Collaborator - IQVIA Ltd ( UK )
GIANLUCA LUCREZI - Collaborator - IQVIA Solutions Italy S.r.l
Gianluca Lucrezi - Collaborator - IQVIA AG (Switzerland)
Quratul Ann - Collaborator - IQVIA Ltd ( UK )
Quratul Ann - Collaborator - IQVIA
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation