Optimisation of Nutrition and Medication for Acutely Admitted Older Medical Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 193
- Locations
- 2
- Primary Endpoint
- Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1)
Study Overview
Brief Summary
Malnutrition and inappropriate medication prescribing are highly prevalent among acutely admitted older medical patients leading to re-admissions, frailty, poor physical, performance compromised quality of life and mortality. Thus, the aim of this study is to optimise the nutrition and medication in older medical patients admitted to an acute care department at admission and up to 16 weeks after discharge. Participants in the intervention group receives a medication review and participants with malnutrition or risk of malnutrition additionally receive a transitional multimodal intervention. The control group receives standard care.
Detailed Description
The OptiNAM study is designed as a single-blinded randomised controlled trial starting upon admission and continues till 16 weeks after discharge. The trial has five sub-studies with three independent primary endpoints, all with individual sample size calculations.
The study consists of an intervention group and a control group. The control group receives standard care.
Patients that meet all inclusion criteria and none of the exclusion criteria are invited to participate. After signing a written informed consent, the participants are block randomised to either the intervention or control group.
The intervention group receives a personalised rehabilitation program, which is described below. Outcome measures are performed at baseline, week 8 and week 16 after after discharge, cf. section regarding outcome measures.
Sub study 1, Malnutrition:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥65 years
- •Acutely admitted medical patients
- •Understand and speak Danish
- •Caucasian
- •Resident in Municipality: Brøndby, Hvidovre or Copenhagen
Exclusion Criteria
- •Unable to cooperate cognitively
- •Terminal/suicidal patients
- •Patients in isolation
Outcomes
Primary Outcomes
Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1)
Time Frame: Baseline (admission day), week 8 and week 16.
Patient administered quality of life scoring system with focus on mobility, daily activities, pain and discomfort and depression.
Changes in Medication Appropriateness Index-score" (sub-study 2)
Time Frame: Baseline (admission day), week 8 and week 16.
Medical physician, geriatric or senior pharmacist perform the MAI-scoring to evaluate the appropriateness of the medication prescribing.
Accuracy of renal function estimates (sub-study 3) - cystatin C
Time Frame: Baseline (admission day) or no later than 14 days after admission
Differences between GFR measured by a renally excreted radioactive labeled isotope (chromium 51-Cr-EDTA or 99mTc diethylenetriaminepentaacetic acid) and estimated GFR based on Creatinine and Cystatin C or a combination of the biomarkers.
Secondary Outcomes
- Patient records(Baseline (admission day), week 8 and week 16.)
- Anthropometric measurement to monitor changes in bodyweight(Baseline (admission day), week 8 and week 16.)
- Potentially inappropriate medication to elderly(Baseline (admission day), week 8 and week 16.)
- Accuracy of renal function estimates - all biomarkers(Baseline (admission day) or no later than 14 days after admission.)
- Dosing discrepancies of renal risk medication(Baseline (admission day) or no later than 14 days after admission.)
- Measure of physically active time and number of steps taken(Week 1, week 8 and week 16 after discharge)
- Cognitive test aiming to evaluate cognitive function(Baseline (admission day), week 8 and week 16)
- Intestinal microbiome composition(Baseline (admission day), week 8 and week 16 after discharge.)
- Body composition(Up to three weeks after admission during kidney function measurement)
- Walking speed to evaluate the development in physical performance(Baseline (admission day), week 8 and week 16.)
- Standard admission blood work(Baseline (admission day), week 8 and week 16.)
- Evaluation of medication under-prescribing(Baseline (admission day), week 8 and week 16)
- Inflammatory marker to evaluate the inflammatory state(Baseline (admission day), week 8 and week 16.)
- Nutritional status(Baseline (admission day), week 8 and week 16.)
- Quality of life score, WHO-5(Baseline (admission day), week 8 and week 16)
- Polypharmacy(Baseline (admission day), week 8 and week 16.)
- Acceptance of suggested changes in medications(Baseline (admission day), week 8 and week 16.)
- Assessment of dietary intake after admission(Week 8 and week 16)
- Functional measurement to evaluate the development in physical performance(Baseline (admission day), week 8 and week 16.)
- Frailty assessment(Baseline (admission day), week 8 and week 16.)
- Cognitive performance(Week 8 and week 16)
Investigators
Ove Andersen
Head of Clinical Research Centre
Hvidovre University Hospital