Optimisation of Nutrition and Medication for Acutely Admitted Older Medical Patients

NCT ID: NCT03741283

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2022-07-15

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:

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.

Conditions

Aging; Malnutrition; Drug Prescribing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Optimisation of nutrition and medication

Intervention Type: OTHER

1. 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.

2. 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.

Standard care

N= approx. 65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Optimisation of nutrition and medication

1. 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.

2. 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Centre

UNKNOWN

Sponsor Role: collaborator

Region Hovedstadens Apotek

OTHER_GOV

Sponsor Role: collaborator

Udviklings- og forskningspuljen, Danske Regioner og Sundhedskartellet

UNKNOWN

Sponsor Role: collaborator

Region Capital Denmark

OTHER

Sponsor Role: collaborator

Regionernes Lægemiddelorganisation

UNKNOWN

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ove Andersen

Head of Clinical Research Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ove Andersen, MD, PhD

Role: STUDY_CHAIR

Hvidovre University Hospital

Aino L. Andersen, MSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Amager & Hvidovre Hospital

Hvidovre, Capital Region, Denmark

Countries

Denmark

References

Andersen AL, Houlind MB, Nielsen RL, Jorgensen LM, Bengaard AK, Bornaes O, Juul-Larsen HG, Hansen NM, Brochner LD, Hansen RG, Skovlund CAR, Pedersen AML, Beck AM, Pedersen MM, Petersen J, Andersen O. Effectiveness of a multidisciplinary and transitional nutritional intervention compared with standard care on health-related quality of life among acutely admitted medical patients aged >/=65 years with malnutrition or risk of malnutrition: A randomized controlled trial. Clin Nutr ESPEN. 2024 Jun;61:52-62. doi: 10.1016/j.clnesp.2024.02.031. Epub 2024 Mar 13.

Reference Type: DERIVED

PMID: 38777473 (View on PubMed)

Iversen E, Bengaard AK, Leegaard Andersen A, Tavenier J, Nielsen RL, Juul-Larsen HG, Jorgensen LM, Bornaes O, Jawad BN, Aharaz A, Walls AB, Kallemose T, Dalhoff K, Nehlin JO, Hornum M, Feldt-Rasmussen B, Damgaard M, Andersen O, Houlind MB. Performance of Panel-Estimated GFR Among Hospitalized Older Adults. Am J Kidney Dis. 2023 Dec;82(6):715-724. doi: 10.1053/j.ajkd.2023.05.004. Epub 2023 Jul 28.

Reference Type: DERIVED

PMID: 37516299 (View on PubMed)

Other Identifiers

VD-2018-390 -"optiNAM"

Identifier Type: OTHER

Identifier Source: secondary_id

OptiNAM

Identifier Type: -

Identifier Source: org_study_id