Optimisation of Nutrition and Medication for Acutely Admitted Older Medical Patients (OptiNAM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malnutrition; Aging; Drug Prescribing
• Intervention / Treatment: Other: Optimisation of nutrition and medication

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:

As malnutrition among older patients has multifactorial etiology sub-study 1 investigates the effects of a multimodal transitional intervention on quality of life in acutely admitted older patients with malnutrition or risk of malnutrition (according to the Mini Nutritional Assessment - Short Form) from baseline (admission day) and 16 weeks after discharge compared to standard care. The intervention includes a medication review (cf. sub-study 2), a dietetic intervention and if clinical relevant physiotherapeutic-, occupational-, geriatric- and/or odontological intervention. It is secondary hypothesised that a multimodal intervention compared to standard care may improve the quality of life, nutritional status, energy- and protein intake, symptoms which compromise nutritional intake, physical performance, cognitive function, frailty, re-admissions, inflammation and biomarkers. A cost-benefit analysis will be conducted.

Dietetic intervention: The study subjects receives a personal diet plan during admission. The diet plan is reviewed at discharge by a dietician. To ensure optimal energy- and protein intake after discharge, a community-based dietician visit the participants for one hour in week 1, 2, 4 and 8.

Physiotherapeutic intervention: Participants with low ability to perform groceries shopping, cooking and/or eating are offered a community-based strength, balance and endurance training after discharge if they also have low muscle strength in the lower extremities. The training sessions are based on algorithms, have a duration of one hour, and are offered twice a week for 16 weeks after discharge.

Occupational intervention, Dysphagia: If relevant (EAT-10 score >=3), a hospital-based occupational therapist review and treat the dysphagia based on the Facial Oral Tract Therapy (FOTT) principle during admission. During the first week after discharge a community-based occupational therapist continues with the treatment. A maximum of two weekly visits of one hour throughout the interventions period is offered.

Occupational Intervention, low Ability to perform Activities of Daily Living (ADL): If the participant has low ability to perform grocery shopping, cooking and eating (evaluated by Functional Recovery Score <=2) then a community-based occupational therapist visit the participant during the first two weeks after discharge to evaluate the quality of activities of daily living. If relevant, and if there is a rehabilitation potential, seven visits of one hour is offered during the 16 weeks after discharge.

Geriatric intervention: If relevant (a Mini Geriatric Depression Score >=2), a geriatric physician conducts a clinical assessment of depression during admission and initiate treatment if necessary.

Odontological intervention: If relevant (participant reported pain in mouth, difficulties chewing or xerostomia), a dentist evaluate the dental status and oral health during admission, and if necessary encourage the participant to consult a dentist after discharge. If a participant shows insufficient oral hygiene a dental hygienist visits the participant after discharge twice during after discharge.

Sub-study 2, Medication optimisation:

Medication prescription for older patients is challenging and may be attributed to marked inter-individual variations in general health, comorbidities, organ function, pharmacokinetic and pharmacodynamic properties, biological age and physical performance. Thus, the "one size fits all" approach is probably inappropriate in older patients. The aim of sub-study 2 is to investigate the investigate the effect of an inter-professional conducted medication review during admission in an acute care department regardless of the nutritional status in the study participant, thus all subjects in the intervention group receive a medication review. It is hypothesized that inter-professional conducted medication reviews reduce the Medication Appropriateness Index score (MAI score) in the intervention group eight weeks after discharge compared to the control group. It is secondary hypothesized that inter-professional conducted medication reviews improve: lack of medication prescribing for a condition/disease, inappropriate polypharmacy and suboptimal medication prescribing of high risk medications.

Sub-study 3, Accuracy of renal function estimates and the consequence for prescribing recommendations guidelines:

Accuracy in renal function estimates is essential for optimization of medication prescribing since 40 % of all medication or their active metabolites is renally excreted. Lack of medication prescribing and dose adjustment according to the renal function is common in older patients with renal impairment and can result in overdosing, adverse drug reactions, hospital admissions, reduced quality of life and mortality. The gold standard for measuring glomerular filtration rate (GFR) is an exogenous filtration marker. However, this method is costly, time consuming and thus impractical in a clinical setting. Therefore, GFR is often estimated on serum concentrations of an endogen biomarker. Sub-study 3 aim to investigate which biomarker(s) and equation most accurately estimate the GFR in older medical patients who have been acutely admitted.

Sub-study 4, Pharmacogenetic test on cytochrome 450 variations and its potential for optimization of medication prescribing:

Cytochrome 450 enzymes are responsible for metabolism of up to 80% of all medications. The enzyme complex is mainly found in liver but are also present in intestinal mucosa, skin, lungs, brain and kidneys. There are major genetic inter-individual differences in the activity of the CYP 450 complex, resulting in lack of therapeutic effects, lack of effect or adverse drug reactions. Insight into these genetic inter-individual differences via pharmacogenetic tests possess a potential in optimization of medication prescribing with regard to therapeutic effects, compliance and risk of side effects. Thus, sub-study 4 wish to descriptively investigate the potential of pharmacogenetic test on cytochrome 450 variations.

Sub-study 5, Assessment of Frailty:

Frailty is a common clinical syndrome in older adults and defined as state of increased vulnerability resulting from decline in reserve capacity and function across multiple physiologic systems. Frailty affects the person's ability to cope with everyday life and leads to high risk for falls, disability, hospitalization and mortality. The frailty assessment is based on two different frailty scoring systems, Frieds "Frailty Phenotype" and Morley's "Frail Scale", examined at admission and 8 and 16 weeks after discharge. The purpose of the assessment is to evaluate which frailty measure is the best applicable in describing the patients and changes in their functional level. As there is no gold standard we use FI-Outref as an independent measure of frailty. FI-OutRef is a Frailty Index, based on standard admission laboratory test results Outside of the Reference interval.

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Hovedstaden
    • Hvidovre, Region Hovedstaden, Denmark, 2650
      • Amager & Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimisation of nutrition and medication; N=approx. 65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.	Other: Optimisation of nutrition and medication; Inter-professional optimisation of medication prescribing:Study participants in the intervention group receives optimisation of medication prescribing at admission day (baseline) regardless of nutritional state. The intervention is performed in cooperation between a clinical pharmacist and a medical physician.; Nutritional intervention: If positive screening for malnutrition or risk of malnutrition a dietetic intervention is initiated and if positive screening below interventions are initiated: Dysphagia: occupational therapy intervention.; Oral cavity problems: odontological intervention.; Depression: geriatric intervention.; Low ADL: occupational therapy intervention and if positive screening for poor muscle strength: physiotherapeutic intervention.
No Intervention: Standard care; N= approx. 65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1)	Patient administered quality of life scoring system with focus on mobility, daily activities, pain and discomfort and depression.	Baseline (admission day), week 8 and week 16.
Changes in Medication Appropriateness Index-score" (sub-study 2)	Medical physician, geriatric or senior pharmacist perform the MAI-scoring to evaluate the appropriateness of the medication prescribing.	Baseline (admission day), week 8 and week 16.
Accuracy of renal function estimates (sub-study 3) - cystatin C	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.	Baseline (admission day) or no later than 14 days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed to evaluate the development in physical performance	4-Meter Walk Test	Baseline (admission day), week 8 and week 16.
Functional measurement to evaluate the development in physical performance	30-second chair stand test	Baseline (admission day), week 8 and week 16.
Functional measurement to evaluate the development in physical performance	handgrip strength test	Baseline (admission day), week 8 and week 16.
Functional measurement to evaluate the development in physical performance	The de morton mobility index	Baseline (admission day), week 8 and week 16.
Measure of physically active time and number of steps taken	Assessed by applying an activPAL chip to the thigh for one week	Week 1, week 8 and week 16 after discharge
Frailty assessment	Fried frailty phenotype	Baseline (admission day), week 8 and week 16.
Frailty assessment	Morleys frail questionnaire	Baseline (admission day), week 8 and week 16.
Anthropometric measurement to monitor changes in bodyweight	Bodyweight	Baseline (admission day), week 8 and week 16.
Cognitive test aiming to evaluate cognitive function	Orientation Memory Concentration test	Baseline (admission day), week 8 and week 16
Patient records	Contacts related to the health care system, medication lists, use of municipal services	Baseline (admission day), week 8 and week 16.
Standard admission blood work	ALAT, albumin, alkaline phosphatase, bilirubin, CO2, CRP, haemoglobin, INR, K+, blood urea nitrogen, coagulation factors, leucocytes, neutrophils, MCH, MCV, Na+, thrombocytes, lactate-dehydrogenases, NGAL, β-trace protein and β-trace microglobulins.	Baseline (admission day), week 8 and week 16.
Quality of life score, WHO-5	Patient administered quality of life scoring system with focus on general well-being on a scale from 0-100.	Baseline (admission day), week 8 and week 16
Cognitive performance	Mini mental state examination	Week 8 and week 16
Cognitive performance	Hopkins verbal learning test	Week 8 and week 16
Cognitive performance	Trail making test	Week 8 and week 16
Cognitive performance	Digit Symbol Substitution test	Week 8 and week 16
Assessment of dietary intake after admission	24 hours dietary recall	Week 8 and week 16
Evaluation of medication under-prescribing	Assessment of underutilization Index (AOU)	Baseline (admission day), week 8 and week 16
Inflammatory marker to evaluate the inflammatory state	SuPAR	Baseline (admission day), week 8 and week 16.
Polypharmacy	The number of patients in polypharmacy	Baseline (admission day), week 8 and week 16.
Potentially inappropriate medication to elderly	The number of potentially inappropriate medication prescriptions	Baseline (admission day), week 8 and week 16.
Acceptance of suggested changes in medications	Frequency of physicians' acceptance of suggested changes in medications	Baseline (admission day), week 8 and week 16.
Accuracy of renal function estimates - all biomarkers	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, Cystatin C, Beta-trace protein, Beta-2 microglobulin or a combination of the biomarkers.	Baseline (admission day) or no later than 14 days after admission.
Dosing discrepancies of renal risk medication	Frequency of renal risk medication prescribed in disagreement to clinical recommendation guidelines based on measured GFR and the choice of eGFR biomarker.	Baseline (admission day) or no later than 14 days after admission.
Nutritional status	Screening scores for undernutrition with Mini Nutritional Assesment - Short Form, Eating validation scheme, Nutritional Risk Screening-2000	Baseline (admission day), week 8 and week 16.
Intestinal microbiome composition	Composition and changes in the intestinal microbiome.	Baseline (admission day), week 8 and week 16 after discharge.
Body composition	Description and changes in body composition, assessed by bioelectric impedance analysis (InBodyS10).	Baseline (admission day), daily through out admission, up to three weeks after admission during kidney function measurement, week 8 and week 16 after discharge.
Body composition	Assessed by dual x-ray absorptiometry (DXA)	Up to three weeks after admission during kidney function measurement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and types of actionable gene variants - Pharmacogenetic test	The number of actionable gene variants identified by the pharmacogenetic test	Baseline (admission day)
Number and types of recommended therapy changes -Pharmacogenetic test	The number of actionable gene variants identified by the pharmacogenetic test	Baseline (admission day)
Health economy related to Sub-study 1	Health care costs will be evaluated in regards to changes in quality of life measured by EURO-Qol-5D-5L.	Baseline (admission day), week 8 and week 16 and 1 year after discharge

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Region Capital Denmark; Region Hovedstadens Apotek; Clinical Research Centre; Udviklings- og forskningspuljen, Danske Regioner og Sundhedskartellet; Regionernes Lægemiddelorganisation
• Investigators: Principal Investigator: Aino L. Andersen, MSc, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Quality of life; Polypharmacy; Pharmacogenetics; Emergency Service, Hospital; Food intake; Renal function; Medicines optimisation; Multimodal interventions
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: OptiNAM; VD-2018-390 -"optiNAM" (Other Identifier: Danish Data Protection Agency)

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