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Study Protocol

A transmural intensive dietetic care-pathway for optimal protein intake and physical functioning in malnourished older patients: A protocol for the randomised ProIntens trial

[version 1; peer review: 2 approved with reservations]
PUBLISHED 14 Jan 2025
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Abstract

Background

Disease-related malnutrition is common among hospitalised and recently discharged older adults. Consequences of malnutrition are physical limitations, negative health outcomes, decreased quality of life and increased healthcare costs. Dietetic care can counteract the effects of malnutrition by increasing protein and energy intake. The ProIntens study aims to evaluate the impact of an intensive dietetic care pathway on dietary protein intake and physical functioning in older adults during hospitalisation and after discharge. Process and economic evaluations will be performed.

Methods

The ProIntens study is a multicentre two-armed parallel individually randomised trial in five hospitals in the Amsterdam region. In total, 250 hospitalised older adults, aged ≥55 years and at risk of malnutrition will be randomised to receive regular care (control) or intensive dietetic care (intervention). The intervention consists of intensive personalised care which involves transmural guidance by trained dietitians, supportive materials on protein intake in a social context and a mobilization program during hospitalisation until three months after discharge. Controls will receive regular care. The primary outcome will be the between-groups difference in the mean change on the Short Physical Performance Battery three months after discharge. Secondary outcomes include dietary protein intake, body composition, physical activity, activities of daily living, quality of life and healthcare costs.

Discussion

The ProIntens trial will study the effects and costs of an intensive dietetic treatment on recovery outcomes in hospitalised older adults at risk of malnutrition. The intervention will result in practical tools for care professionals which aim to improve malnutrition treatment for older patients.

Trial registration

Landelijk Trial Register (NL8041; NL72069.029.19); registered 2019-09-23; covering all WHO Trial Registration Data Set items.

Keywords

Older adults, undernutrition, transmural care, muscle mass, process evaluation, cost-effectiveness, hospitalization, primary health care

Background

For older adults, hospitalization in itself can have major side effects, regardless of the reason for their hospital admission.1 Malnutrition during hospitalization is associated with prolonged hospital stay, more complications and readmissions and increased health care costs.2,3 This combination of a poor nutritional status and loss of physical functioning leads to decreased quality of life and increased mortality.2,4

Major factors in malnutrition and physical functional decline is an inadequate protein intake. Current guidelines suggest an intake of 1.2-1.5 g protein/kg bodyweight/day to support recovery during hospitalisation and after discharge.57 To meet the nutritional guidelines, patients at risk of malnutrition should be provided with a nutritional care plan with guidance of a dietitian. Dietetic treatment focusing on protein and energy intake can improve patients’ physical function, quality of life, and lower all-cause mortality.8,9 However, older patients have difficulties meeting these guidelines. In 2019, Weijzen et al. observed an average protein intake of 0.6 g/kg/d in older patients.10 Also, dietitians stated in recently-held focus groups they perceive barriers (time, money, inter-disciplinary collaboration) in treating older patients according to the guidelines. In addition, these issues are not only faced during hospitalization but also after discharge. The first three months after discharge are critical for health recovery for older patients.11 Improvement in the transmural care-pathway for older malnourished patients is therefore called for.

This protocol present the ProIntens study, which aims to develop and test a new intensive dietetic care intervention for older patients at risk of malnutrition, admitted to hospital, focusing on protein intake and mobility. The treatment will start at hospital admission and will continue until three months after hospital discharge. The primary objective of the ProIntens study is to study whether physical functioning of older patients at risk of malnutrition during hospitalisation and after discharge is improved by this transmural intensive dietetic intervention. Secondary objectives of the ProIntens study are to investigate whether personal protein goals, improved mobility and Activities of Daily Living (ADL), increased muscle mass and strength, improved quality of life are achieved, and study reductions of length of hospital stay, readmission rates, mortality and societal costs.

Methods

Trial registration

Landelijk Trial Register (NL8041; NL72069.029.19); registered 2019-09-23; covering all WHO Trial Registration Data Set items.

Study design

The ProIntens study is a two-armed multicentre parallel individually randomised trial. After determining eligibility and obtaining informed consent, participants are randomised 1:1 to either the control group or intervention group. Participants in the control group will receive regular care (RC), while participants in the intervention group will receive intensive dietetic care (IDC). Measurements will be performed at hospital admission (t0), discharge (t2), and at one (t3)- and three-months after discharge (t4).

Setting, participants and recruitment

The study population will consist of hospitalised older adults (≥55y), who are at risk of malnutrition. Five hospitals in the region of Amsterdam will participate: Amsterdam University Medical Centers, location AMC (1000 beds) and VUmc (733 beds), teaching hospital OLVG, location Oost (555 beds) and West (366 beds) and regional hospital BovenIJ (313 beds). Participants will be recruited from the following medical wards: geriatrics, internal medicine, cardiology, gastroenterology, pulmonology and the acute admission unit (a non-emergency triage ward where patients undergo further tests and stabilisation before being transferred to a suitable ward). To identify participants at risk of malnutrition, four validated screening tools specifically designed for older adults and the hospital setting will be performed within 48 hours after hospital admission, namely: Short Nutritional Assessment Questionnaire (SNAQ), Malnutrition Universal Screening Tool (MUST), Mini Nutritional Assessment Short Form (MNA-SF), and the Malnutrition Screening Tool (MST).12 The cut-off value for the risk of malnutrition for SNAQ is ≥3 points, for MUST is ≥2 points, for MST is ≥2 points and for MNA-SF is ≤11 points. Participants at risk of malnutrition are eligible for inclusion if one or more of the four screening tools indicates such risk as by their respective cut-offs. The patient will be approached for participation after consultation with the clinical team. After obtaining written informed consent, the participant is further screened for eligibility. Other in- and exclusion criteria are listed in Table 1. Recruitment for the study will start 21st of January 2021 and will continue until 31st of December 2022.

Table 1. Inclusion and exclusion criteria for the ProIntens study.

Inclusion criteria Aged 55 or older
At risk of malnutrition
Written informed consent
Ability to comply with the study protocol
Willingness to comply with the study protocol
Agrees that his/her general practitioner will be notified about study participation
Consent of the participants’ in-hospital clinical team
Exclusion criteria Inability to understand the Dutch language
Cognitive impairment (MMSE <15)
Current/admission diagnosis of cancer or active cancer treatment (systemic and/or immune therapy)
COPD GOLD >3
Heart failure NYHA >3
Initially admitted to intensive care unit
Use of total parenteral nutrition
Palliative treatment or a life expectancy of ≤3 months

Sample size calculation

The sample size is based on the difference in changes of the Short Physical Performance Battery (SPPB) in the study of Tieland et al13 and observational data from older patients, aged 70 and older, who were at risk of malnutrition.14 The following estimates were used: effect size of 1-point difference in mean change from admission to 3 months post-discharge between the intervention and control group and a standard deviation (SD) of 2.5. With a significance level (α) of 0.05 and a power of 80%, a sample size of 99 participants per group was estimated. Assuming a drop-out of approximately 25%, a total number of 125 participants per group was needed, leading to a total of 250 participants to be included in the study.

Procedures and randomisation

Eligible participants will be contacted by a member of the research team and after receiving written and oral explanation of the study procedures, the participants will have at least 3 hours to consider participation. When all questions are answered and the participant expresses his/her willingness to participate, the informed consent form will be signed, after which the participants will be screened on eligibility (see Table 1). Eligible patients will be randomized using data management program Castor EDC block randomisation algorithm (Castor EDC©, Amsterdam, The Netherlands). Variable block sizes2,4,6 are used in random order, stratified by hospital. When a participant’s case report form is entered in Castor EDC and fulfils all inclusion criteria and none of the exclusion criteria, a researcher with randomization rights (only CD and DS) clicks the ‘Randomize’ button within 1 hour after informed consent was obtained. Randomization cannot be undone and is logged in the audit trail. The group allocation of patients is not visible for data-entry personnel. Due to the nature of the intervention, the study coordinators (CD, JV, DS, ME), dietitians and participants are not blinded to allocation.

Data will be collected at five time points; within 48 hours after admission (t0), at the 4th day of admission (t1), at discharge (t2), one month after discharge to home (t3) and three months after discharge (t4). Table 2 provides an overview of the time, location, content of assessment and duration of data collection per time point. The measurements will be performed by a team of trained professionals according to the Dutch Medical Research Involving Subjects Act, ICH-GCP guidelines and Standard Operating Procedures. The team is supervised by the study coordinators (CD, JV, DS). Data will be collected on paper using Case Report Forms, which are stored at participating centres. Research team members enter the data in the online data management system Castor EDC (Castor EDC©, Amsterdam, The Netherlands). Personal information will be stored in password protected files, only accessible by the research team, according to the European General Data Protection Regulation.

Table 2. Time, location, content of assessment and duration of the ProIntens study.

TimeLocationContent of assessment Duration (minutes)
t-1 within 48 hours of admission HospitalInforming patient
Obtain written informed consent
Socio-demographics
Medical history
Cognitive performance
20
Inclusion and randomisation HospitalInform patient about inclusion and group allocation5
Control group continues in regular care; intervention group starts Intensive Dietetic Care-pathway
t0 withing 48 hours of admission HospitalPhysical functioning and performance
Nutrition intake registration
Body composition
Medical and demographic data
Behavioural and psychosocial functioning
Health cost questionnaire
Quality of life
Blood parameters
90
t1 4th day of admission HospitalBody composition
Nutrition intake registration
20
t2 around hospital discharge Hospital or home visitPhysical functioning and performance
Nutrition intake registration
Body composition
Behavioural and psychosocial functioning
Health cost questionnaire
Quality of life
Blood parameters (medical record)
Length of hospital stay
90
t3 one-month post-discharge Home visitPhysical functioning and performance
Nutrition intake registration
Body composition
Behavioural and psychosocial functioning
Health cost questionnaire
Quality of life
Readmissions (timing, reason, duration)
90
t4 three-months post discharge Home visitPhysical functioning and performance
Nutrition intake registration
Body composition
Behavioural and psychosocial functioning
Health cost questionnaire
Quality of life
Blood parameters
Readmissions (timing, reason, duration)
Mortality
90

Intervention mapping

In the development of the intensive dietetic care pathway, an Intervention Mapping (IM) approach was used.15,16 The framework consists of six steps and helped to process effective health behavioural theories and behavioural change techniques into the intervention. In step 1 of IM, we defined the problem17 and performed an additional needs assessment with different disciplines involved in the treatment of older patients, to identify potential strategies (publication in press). In step 2 and 3 of IM, a logical model of change was created to show which behavioural change techniques underlie parts of the intervention and their proposed change in the behavioural and health outcomes. Step 4 of IM consisted of the production of the intervention materials. For an extensive overview of the applications and their underlying behavioural changes techniques, see Table S1 and S2 in Supplementary file 1.69 In step 5 of IM, the implementation of the intervention will be performed. Actions needed for implementation are providing training to dietitians, physiotherapists, nurses, treating physicians, nutrition assistants and care givers around the patient. Online and offline training sessions will be created for this purpose. Step 6 of IM consists of the evaluation. Next to the evaluation of the effect of the intervention, also process and economic evaluation will be performed. To evaluate the implementation process, information on five process indicators will be assessed, being Recruitment/Reach, Dose received, Acceptability, Applicability, Implementation integrity.1821 For the economic evaluation, information on quality of life, and the use and costs of healthcare will be assessed using validated questionnaires.22,23

Intervention

Control group

Participants in the control group will receive regular care and for the study only additional measurements will be performed (see Figure 1). Within current regular care, screening for risk of malnutrition is done with the SNAQ screening tool only.24 When the patient is found to be at risk, a dietitian is consulted by the nurse. When consulted, the dietitian specifies the nutritional status of the patient and develops a personalised protein and energy-enriched diet. The treatment goal is to reach the recommended protein and energy intake on the 4th day of admission based on the Dutch guideline for malnutrition.25 Oral nutritional supplements or enteral nutrition via tube feeding can be used to achieve this goal. Follow-up of treatment differs greatly in practice. Some patients are lost to follow-up, some in-hospital dietitians perform a few telephone follow-ups, others hand over the patient to a primary care dietitian. If a patient has trouble with Activities of Daily Living (ADL) during hospitalisation, an in-hospital physiotherapist may be consulted. The focus of physiotherapy is usually ‘what must the patient be able to do, to be dischargeable’. A hand-over file is given to the patient at discharge, after which patients can decide for themselves if they want a follow-up treatment from a primary care physiotherapist.

3bbf01f8-8726-42bf-9528-58cf45953a80_figure1.gif

Figure 1. Summary of enrolment, intervention and outcomes assessed at the different time points.

Intervention group

For participants at risk of malnutrition in the intervention group, nutritional support will be initiated as soon as possible. Participants in this group will receive personalised intensive dietetic care (IDC) based on the scientific literature (see Table 3).5,2529 The nurses and nutritional assistant will be informed by the research team to start patients on a protein and energy-rich diet within 24 hours after admission. In addition, the dietitian will be informed by the study coordinators immediately so treatment can start within 48 hours. The treatment goal is to reach the recommended protein and energy intake on the 4th day of admission and continuously after discharge. There is a set of smaller and larger adjustments that align consultation, interprofessional collaboration and communication. Determining the nutritional status, which is done at admission by a dietitian, are more specific than currently done in regular care (see Table 3). Oral nutritional support (ONS) or enteral nutrition via tube feeding can be used to achieve the protein and energy goal. The monitoring by the dietitian is intensified and supported by nutritional assistants, nurses, physiotherapists and informal caregivers. For all strategies applied within the intensive dietetic care, see Table 3. These strategies are based on the needs assessment and behavioural change theories and techniques (see Supplementary file 1, Table S1 and Table s269).

Table 3. Overview of different strategies applied within the intensive dietetic care intervention, compared with regular care.

StrategyRegular care (control)Intensive Dietetic Care (intervention)
Assessment of bodyweight

  • Patient is asked his/her current weight; rarely is it measured

  • Measured at admission and monitored every other day during hospital stay

Protein goal per day

  • 1.2g/kg self-reported bodyweight

  • 1.5 g/kg fat free mass derived from BIA

  • If FFM not available ➔ 1.2 g/kg (adjusted) measured bodyweight30

Monitoring of energy and protein intake

  • Diet history by dietitian, a few times during treatment

  • Daily record with Rate-a-plate or EiFit application by patient with support of nurse, nutritional assistant and/or dietitian31

Evaluation of treatment plan

  • Hospital: varying

  • After discharge: max 3 hours consultation per year

  • Hospital: every other day

  • After discharge: 6 hours consultation in 3 months

Meals

  • Served to bed

  • Energy/Protein-rich options available upon request of dietitian

  • If possible, at a desk and in ‘social context’32,33

  • Energy/Protein-rich options always available

  • 25-30 g protein per main meal26

  • Late-night snack containing ≥10 g protein

ONS (when needed)

  • Hospital available ONS

  • Hospital available ONS

  • Protein powder supplement containing 10/15 g of whey-protein

Information

  • Hospital-specific leaflet

  • Information folder containing:

    • Infographic “Protein&Exercise”

    • Summary of treatment plan of each involved discipline

    • Contact information of all involved disciplines

    • Instructions on how to register dietary intake

    • Exercise program based on SPPB outcome

    • Poster with simple exercises34

    • Example of a daily menu rich in protein and energy

    • Recipes of protein-rich meals

    • Protein-rich product list

    • Information on home delivery services

  • Knowledge clip “Protein&Exercise”

  • “Protein&Exercise” board (adapted from Elizabeth-Twee Steden Hospital)3537

Physical activity

  • Physiotherapist may be involved

  • Active referral to a physiotherapist3840

  • PAM to stimulate mobilisation

Collaboration

  • Minimal collaboration between involved disciplines

  • Intensive collaboration between involved disciplines, initiated by the dietitian

Discharge follow up

  • Dietitian: varying between no follow-up, follow-up by hospital dietitian, follow-up by primary care dietitian

  • Dietitian: high frequency follow-up by primary care dietitian41,42

Specific tasks for each profession in the intervention

During hospitalisation

Hospital dietitian

The dietitian will have additional treatment time (90 minutes) for each patient to help achieve a tailored protein and energy rich diet. The extra time can be used to elaborate more on the importance of protein and mobility with the help of the knowledge-clip “Protein&Exercise” and infographic “Protein&Exercise”. During an interactive moment, the dietitian informs the family and their caregivers on the importance of protein intake and physical activity of the patient.43 Extra information on how they can support the patient in reaching their goals will be given. The dietitian encourages the patient to not lay in the hospital bed (with assistance of a nurse or physiotherapist if needed) during the day to stimulate physical activity. Other tools the dietitian may use during treatment are motivational interviewing, ONS or enteral tube feeding, focus on timing of protein around exercise and the “Protein&Exercise board” to create an overview of the daily goals. The extra treatment time can be used to collaborate the hospital physiotherapist to align the treatment goals; collaborating and communicating with the nurse and Nutrition Assistant (NA) about the participants’ food intake and treatment directly after first consult and every other day during hospitalisation can improve the participants’ adherence to the treatment plan. When the patient is discharged, the dietitian fills in the ProIntens medical file transfer and sends it to the dietitian in the primary care via secured e-mail. The dietitians will call each other to discuss details on the treatment of the patient within the first week post-discharge.

Hospital physiotherapist

During hospitalisation, the physiotherapist will be consulted at least once to assess which physical activity is safe and feasible for the patient, and to inform the patient on the results of the assessment. The physiotherapist will collaborate with the dietitian and aligns the treatment plans on timing of mobilisation and protein intake. When the patient will be discharged, the physiotherapist sends a medical file transfer to the primary care physiotherapist and/or dietitian.

Nutrition assistant (NA)

The nutrition assistant supports the patient in reaching the treatment goals by referring to the knowledge-clip and infographic “Protein&Exercise”. The NA encourages the patient to consume protein rich meals and products and provides protein rich snacks with a minimum of 5 g and optimally 10 g of protein immediately when requested by a patient. The NA knows the potential barriers to food intake and how to tackle them. During hospitalisation, the NA helps the patient monitoring their food intake with the Rate-a-Plate list or EiFit app (e-version of Rate-a-Plate). The NA provides feedback on nutritional status to the patient and the nurse daily and has direct contact with the dietitian every other day. If needed, the NA helps the patient with adjusting the “Protein&Exercise” board.

After discharge

Primary care dietitian

The dietitian in primary care receives the medical file from the hospital dietitian via secured e-mail and will contact the hospital dietitian to receive additional information on the patient within the first week after discharge. Within the same first few days, the dietitian will contact the patient to schedule the first home visit within the first week after discharge. In addition, the dietitian actively refers the patient to a physiotherapist to continue the support on mobilisation.3840 During the first visit, the follow-up consultations will be planned (weekly contact for four weeks, thereafter biweekly until three months after discharge; see Table 4). During the first home visit, the dietitian may adjust the treatment plan to suit the participant’s home setting. When needed, they can refer to knowledge-clip and infographic “Protein&Exercise” to repeat the importance to continue the treatment plan. During the three months of treatment, the dietitian aids patient learning to monitor food intake based on Rate-a-Plate list or EiFit app and evaluate on intake during every visit. At every visit, the dietitian mentions the importance of physical activity to the participants, family and informal caregivers and encourages the participant to be physically active. The dietitian may refer to the exercise program in the folder. When needed, the dietitian can inform the participant about home delivery and other social services, which are available in the discharge folder.

Table 4. Time and activity overview for primary care dietitian and physiotherapist.

Weeks post-discharge Activity Approximate Time (min)
0 (±3 days)Telephone call15
1Home visit45
Contact with dietitian in hospital for hand-over 10
Contact with primary care physiotherapist15
2Telephone call20
3Telephone call20
4Home visit30
5--
6Telephone call20
7--
8Home visit30
9--
10Telephone call15
11--
12Telephone call (closing)15

Primary care physiotherapist (if consulted)

The consultation of the physiotherapist is dependent on insurance of the patient. When consulted, the physiotherapist receives information on the participant’s participation in the study, and receives the patient files via secured e-mail. During the follow-up the dietitian and physiotherapist collaborate to align the interprofessional treatment plans on timing of mobilisation and protein intake.

Community nurse (if consulted)

When a community nurse is consulted in support of recovery of the patient at home, they will receive information on the presence of malnutrition and the treatment plans, which are available in the discharge folder of the patient. The dietitian and physiotherapist will be notified of the involvement of the community nurse. The community nurse has knowledge on protein rich products and encourages the patient to consume protein rich products. Also, the community nurse can encourage the patient to be active. When the community nurse suspects a low intake, based on the Rate-a-Plate list or the EiFit application, they will notify the dietitian.

Outcomes

Figure 1 provides a detailed overview of the primary and secondary outcomes measured at each time point.

Primary outcome

The primary outcome is the between-groups difference in the mean change on the Short Physical Performance Battery from admission (t1) to three months post-discharge (t4).44 This battery consists of the following tasks: balance stance in three different positions: a side-by-side, semi tandem, and full tandem, walking three or four meters to measure gait speed, and rising from a chair and return, five times as quickly as possible. The total scores can range from 0 to 12 (best performance). If a patient is unable to perform a test, 0 points will be noted. A change of 1 point on the total score has been demonstrated to be clinically meaningful.45,46

Secondary outcomes

  • 1) Physical functioning and performance

    Handgrip strength Handgrip strength is an objective measure of muscle strength in the upper body. Three consecutive measures of handgrip strength (kg) of both hands will be recorded to the nearest 0.5 kg using a hand dynamometer (Jamar). Standardized vocal stimulation will be given, according to the Standard Operating Procedure (SOP) of the Nutritional Assessment Platform (NAP).47 The highest score will be used as a parameter for muscle strength.

    Knee extension strength The knee extension strength is measured with a hand-held dynamometer (MicroFET2). The strength is measured in kilograms (kg). Participants will be asked to be seated on an elevated chair with their knees at a 90° angle, feet off the floor and hands on their thighs. The dynamometer will be placed proximal to the talus and malleolus (ankle). The participants will be asked to slowly increase their muscle force to a maximum effort which will need to be sustained for three seconds. The procedure will be repeated two times for each leg. The highest score will be used as a parameter for lower leg strength.48

    Physical activity Daily physical activity will be registered using a three-dimensional Physical Activity Monitor (PAM). The PAM is a compact, battery-operated electronic accelerometer. Participants are requested to wear the accelerometer around their ankle during hospital stay and a period of three days before t3 and t4. The PAM registers the amount of movement of the user, converted into number of steps and the Pam Score. The Pam Score is the ratio between activity induced energy expenditure and resting metabolic rate.

    Activities of Daily Living (ADL) To assess ADL, the Barthel Index will be used. The questionnaire consists of 10 items on an ordinal scale that relate to the preceding 24-48 hours. A high score on the Barthel Index corresponds to a high degree of independence.49

    Pain and fatigue A Numeric Rating Scale (NRS) will be used to assess pain and fatigue. The NRS for pain is a validated continuous scale with a score range between zero and ten, where zero represents no pain and ten the worst pain possible.50,51 The NRS for fatigue is a continuous scale with a score range between zero and ten, where zero represents no fatigue and ten the worst fatigue possible.52

    Sleep quality To assess sleep quality two questions of the Pittsburgh Sleep Quality Index (PSQI), a self-reported questionnaire, are used, being ‘During the past month, how would you rate your sleep quality overall?’ and ‘During the past month, how often have you taken medicine (prescribed or “over the counter”) to help you sleep?’. Both questions have a range of 0 (better) to 4 (worse).53

  • 2) Nutrition

    Dietary food intake Dietary food intake will initially be registered using the Rate-a-Plate list or the EiFit application (e-version of Rate-a-Plate).31 Rate-a-Plate list and EiFit application are simple but comprehensive tools to make a global estimation of the participants’ nutritional intake. This list will be used as a basis to perform a 24h recall at admission and on the 4th day of admission, and to complement a more detailed 3-day dietary record at discharge, one-month after discharge and three months after discharge. All records will be coded using the Dutch Food Consumption Database (NEVO).54

    Appetite is measured on a numeric rating scale from zero to ten, where zero represents no appetite and ten best appetite possible.

  • 3) Body composition

    Body weight Body weight (kg) will be measured to the nearest 0.1 kg using a calibrated weighing scale without shoes and heavy clothing.

    Height Height (m) will be measured to the nearest 0.01 meter using a stadiometer. If the subject is unable to stand straight, knee height will be measured as it is closely related to stature. Knee height will be measured in a supine position with the knee and ankle in a 90° angle. With a measuring tape, the lower leg is measured from heel to the upper side of the patella on the lateral side of the body. The formula of Chumlea (1998) will be used to assess stature height.55

    Body composition To estimate fat-free mass (FFM) and fat mass (FM) Bioelectrical Impedance Analyses (BIA; Bodystat500 and Quadscan 4000) will be used. Within 30 minutes prior the measurement, the patient is asked to empty their bladder. The patient will be asked to lie in a supine position with the arms not touching the trunk and legs and feet not touching each other. Regular 3M-electrodes will be arranged in the tetrapolar configuration, with the injection electrodes to be placed wrist-to-ankle and the sensing electrodes to be placed hand-to-foot, preferable on the right side of the body.

    Muscle morphology Ultrasound imaging will be used to assess anatomical cross-sectional area (ACSA) of the rectus femoris and vastus lateralis muscle.56 B-mode ultrasound images will be taken with a broadband linear array probe (Phillips Lumify L12-4) at 50% muscle length of the vastus lateralis, and measurements will be performed with the patient in a seated position, with the right leg fully extended. Individual ultrasound images are combined into a single image representing the rectus femoris and vastus lateralis. ACSA and homogeneity (as a sign of fibrosis and/or fat infiltration) will be quantified using ImageJ (National Institutes of Health, USA).57

  • 4) Medical and demographical data

    Socio-demographics Participants’ age, gender, living arrangement, highest level of education, date and time of admission and discharge and medical history will be noted.

    Chronic conditions The Charlson comorbidity Index will be used to score the number and severity of comorbidities. To each condition, a score of 1, 2, 3, or 6 is given, where a higher score corresponds with a greater risk of mortality.58

    Polypharmacy Current medication use will be noted. Polypharmacy will be defined as the use of five medications or more.59

  • 5) Behavioural and psychosocial functioning

    Fear of falling The Numeric rating scale (NRS) for fear of falling is a scale ranging from zero to ten. Zero represents no fear of falling and ten the worst possible fear of falling.

    Depression The Geriatric Depression Scale-15 (GDS-15) will be used to assess symptoms of depression. The GDS-15 is a self-report questionnaire of 15 items on a binary (yes/no) scale and assess symptoms on the preceding week. The total score is the sum of the 15 items and ranges from 0-15, with a higher score indicating more depression symptoms. A score of 0-4 will be considered ‘no depression’, a score of 5-8 as ‘mild depression’, a score of 9-11 as ‘moderate depression and a score of 12 or higher as ‘severe depression’.60,61

    Quality of life The EuroQol-5D (EQ-5D) and Adult Social Care Outcomes Toolkit (ASCOT) are used to assess quality of life. The EQ-5D is a quality-of-life instrument consisting of five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels (no problems to unable to perform). The resulting health states on the EQ-5D-5L will be converted to a utility score using the Dutch EQ-5D-5L tariff.22 The utility scores will be used to calculate Quality-Adjusted Life-Years. The ASCOT is a quality-of-life instrument that measures quality of life from a broader perspective than health alone.23 The ASCOT consists of eight domains (control over daily life, personal cleanliness and comfort, food and drink, personal safety, social participation and involvement, occupation, accommodation cleanliness and comfort, dignity) with four response levels (ideal level to high needs). The ASCOT health states will be valued using the Dutch ASCOT tariff.62

  • 6) Others

    Cost-effectiveness Costs will be assessed from a societal perspective using a retrospective questionnaire. Information on the following cost items will be collected: primary care (e.g., visits to the general practitioner, physical therapy sessions), secondary care (e.g., outpatient visits, AED visits), primary care, medication, informal care (i.e., help from family and friends), and lost productivity (i.e., absenteeism and presenteeism).

    Blood parameters When available, blood parameters (C-Reactive Protein (CRP) and (pre-)albumin) from the medical records will be noted during hospital stay.

    Cognitive performance The Mini Mental State Examination (MMSE) will be used to assess cognitive performance.63 The MMSE is a test that is used in the event of a suspicion of memory problems or dementia. The 23-item questionnaire gives an impression of a person’s memory, language ability and concentration. The total score ranges from 0 to 30 points. Cognitive impairment is defined as a total score below 15 points.

    Readmissions Information on any readmission to the hospital will be retrieved from the medical record and by asking the patient ‘Have you been hospitalised in the last month?’. Data on date of admission and discharge for any readmission, as well as whether the admission was planned or unplanned, will be retrieved from the medical record.

Process evaluation

To assess whether the implementation of the intervention was successful, a process evaluation will be conducted. A total of five process indicators are identified, being Recruitment/Reach, Dose received, Acceptability, Applicability, Implementation integrity.1821 Recruitment/reach describes the procedures used to approach and attract participants and the proportion of intended target audience that participated in the intervention. This latter information will be obtained from the in- and exclusion flowchart. Dose received describes to which extent the participants received the intervention, i.e. number of consultations by dietitian and physiotherapist, discussed items during consultation, times intervention items are used. This information will be obtained from the cost questionnaire and surveys send to dietitian. Acceptability describes the degree of satisfaction of participants and healthcare professionals with the intervention. This information will be obtained through semi-structured interviews in a random subsample of participants who completed the study and healthcare professionals who carried out the intervention. Applicability describes the feasibility of implementing the intervention from the healthcare professional’s point of view. This information will be obtained through semi-structured interviews. Implementation integrity describes the degree to which the intervention was implemented as intended. This information will be obtained through semi-structured interviews with healthcare professionals. In addition, structured observations will be conducted by the research staff and registration forms of the health care professionals will be checked.

Statistical analysis

Summary statistics (mean, median, standard deviation, interquartile range and frequency distribution) will be generated for baseline characteristics. Descriptive data will be used to assess time trends.

SPPB total scores will be visualised over time using mean and standard error of the mean per treatment group and period or with median and interquartile range if needed. Differences between treatment groups in the primary outcome parameter will be analysed using generalized linear mixed models. A dummy variable for time will be created. Important prognostic baseline values will be used as covariates. Secondary outcome measures will be visualised over time using mean and standard error of the mean per treatment group or with median and interquartile range if needed. Changes within and between groups will be modelled with linear mixed models. All data will be analysed according to the intention-to-treat principle. Missing data will be handled with linear mixed models. An α-level of 0.05 will determine statistical significance. Data validation is performed by blinded project leaders (HK, MT). Further analyses will be stated in the Statistical Analysis Plan which will be finalised and put in the public domain via Figshare repository before unblinding of the dataset.

Economic evaluation

The economic evaluation will be done from a societal perspective according to the intention-to-treat principle. Following the guidelines for economic evaluations, provided by the Dutch Healthcare Institute, standard prices are used to calculate costs.64 Both a cost-effectiveness analysis with SPPB as the outcome measure and a cost-utility analysis with the EQ-5D5L and ASCOT as outcome measures will be performed. Missing cost and effect data will be imputed using multiple imputation with predictive mean matching. Cost and effect differences will be estimated using linear mixed models in combination with bootstrapping. Statistical uncertainty surrounding the incremental cost-effectiveness ratio will be estimated using bootstrapping. Cost-effectiveness acceptability curves will be estimated to show the probability that the intervention is cost-effective in comparison with usual care for different willingness-to-pay thresholds (i.e., the maximum amount of money society is willing to pay per unit of effect extra).

Ethics approval and consent to participate

This study is approved by the Medical Ethics Committee (METc) of the Amsterdam University Medical Center (AUMC), location VUmc in The Netherlands (Protocol ID: 2019.689 (approved on 10th of July 2020) and Amendment ID: A2020.361 (approved on 26th of July 2021)). Written informed consent is obtained from all participants before any data is collected. Insurance has been taken out for compensation to those who suffer harm form the trial participation. The research is performed according to the Dutch Medical Research Involving Human Subjects Act (WMO) and the principles of the Declaration of Helsinki (64th W MA General Assembly, Fortaleza, Brazil, October 2013).

Consent for publication

Not applicable.

Availability of data and materials

Recruitment of participants will continue until 31-12-2022. After completion of the trial, data will be stored and shared through Figshare.

Study status

The study has finished recruiting subjects on the 31st of December 2022.

Discussion

Disease related malnutrition is a prevalent problem in hospitalised and discharged older adults. Consequences of malnutrition are physical limitations, lower quality of life and higher healthcare costs. Dietetic care counteract the effects of malnutrition by increasing protein and energy intake. However, older adults have difficulties consuming adequate dietary protein and many are physically inactive. Important factors for improving dietetic care are patient self-management, early mobilisation, multidisciplinary collaboration between professionals. Here we present a multi-component intensive dietetic care-pathway based on the pertinent literature. Using the intervention mapping framework to develop the intervention helped to incorporate behavioural change techniques and match the components of the intervention to the needs of the end-users. Our study builds on the needs of involved disciplines, expert opinions and previous studies conducted in the hospital setting or the post-discharge setting.8,9,6568 The ProIntens intervention tries to provide evidence about the question to which extent an intensive treatment with guidance of a dietitian and a physiotherapist, compared to currently regular care in five hospitals in the Netherlands is able to improve a patients recovery by continuing care after discharge. Also, by basing the components of the intervention on behavioural change theories we hope to provide a constant awareness of the importance of protein intake and physical activity, with various tools within the direct surroundings of the patient, with the support of caregiver. Initially the study was designed as a stepped-wedge design, with 15 hospital wards as clusters. However, due to the outbreak of COVID-19, the hospital wards changed drastically, which made it impossible to conduct the study in that fashion. The study was redesigned to a parallel-RCT although this increases the chances of contamination during the hospital phase as hospital care professionals could guide control group patients similar to intervention group patients. We tried to overcome this by carefully instructing the care professionals to make sure intervention components are not used in regular care. An advantage of the parallel-RCT design is that within each hospital there are patients either receiving regular care or the intervention. Also, due to the use of block randomisation, control and intervention patients will be spread evenly over time. In addition, the intervention is implemented in every participating hospital. The ProIntens study will provide valuable evidence and insights that may have a major impact on level and timing of patients’ recovery, both in a hospital and primary care setting. The latter might be a major step in improving dietetic care and implementing the ProIntens intervention.

Authors’ contributions

PW acts as the study Principal Investigator. PW, MT and HK wrote the research proposal that was sent to the funding organisation. All authors designed the RCT. CD and JV drafted the manuscript and CD, JV, ME and JB wrote the protocol for the Medical Ethics Committee. JB provided expertise on cost-effectiveness. GT provided methodological and statistical expertise. ME and RW provided expertise on ultrasound measurements. CD, MT and HK are responsible for study management. CD, DS and ME are responsible for data collection. All authors critically revised and approved the final version of the manuscript.

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van Dronkelaar C, Tieland M, Kruizenga H et al. A transmural intensive dietetic care-pathway for optimal protein intake and physical functioning in malnourished older patients: A protocol for the randomised ProIntens trial [version 1; peer review: 2 approved with reservations]. F1000Research 2025, 14:81 (https://doi.org/10.12688/f1000research.146426.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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Reviewer Report 04 Apr 2025
Barbara S Van der Meij, HAN University of Applied Sciences, Nijmegen, The Netherlands 
Approved with Reservations
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Thank you for the opportunity to review the protocol of the  ProIntens study, which is an RCT investigating an interdisciplinary and transmural nutrition and physiotherapy care pathway for older adults at risk of malnutrition and admitted to hospital. 
The protocol ... Continue reading
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Van der Meij BS. Reviewer Report For: A transmural intensive dietetic care-pathway for optimal protein intake and physical functioning in malnourished older patients: A protocol for the randomised ProIntens trial [version 1; peer review: 2 approved with reservations]. F1000Research 2025, 14:81 (https://doi.org/10.5256/f1000research.160515.r370886)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 27 Mar 2025
Martine J. Sealy, Research Group Healthy Ageing, Allied Health Care and Nursing, Hanze University of Applied Sciences, Groningen, The Netherlands 
Approved with Reservations
VIEWS 8
Thank you for inviting me to review the protocol for the ProIntens study. The ProIntens study is a multicenter, randomized controlled trial investigating the effects of intensive dietetic care on dietary protein intake and physical functioning in malnourished older adults during ... Continue reading
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Sealy MJ. Reviewer Report For: A transmural intensive dietetic care-pathway for optimal protein intake and physical functioning in malnourished older patients: A protocol for the randomised ProIntens trial [version 1; peer review: 2 approved with reservations]. F1000Research 2025, 14:81 (https://doi.org/10.5256/f1000research.160515.r370882)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

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VERSION 1 PUBLISHED 14 Jan 2025
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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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