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Trial registered on ANZCTR


Registration number
ACTRN12611000851965
Ethics application status
Approved
Date submitted
18/07/2011
Date registered
10/08/2011
Date last updated
10/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
What is the best way to provide dietetic care to patients admitted to hospital who have been identified as having illness related malnutrition: Which of two current service models benefits patients in the long term?
Scientific title
An RCT on medical and surgical patients identified as "at risk "or malnourished during their hospital stay, who receive either standard dietetic care or long term ambulatory dietetic care and the changes in their nutritional status after six months receiving either care.
Secondary ID [1] 262604 0
Nil
Universal Trial Number (UTN)
Trial acronym
COMMIIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Illness related malnutrition 268298 0
Condition category
Condition code
Diet and Nutrition 270618 270618 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two current models of care will be employed during the intervention period and they are described below:

a) Hospital Model of Care ( HMoC):
Patients who receive the HMoC will receive the following services:
1. Full nutrition assessment as per departmental standards
2. Nutrition care plan developed and implemented during the hospital admission. Discretionary referral to the ambulatory care dietitian.
3. All the Dietary Education provided during hospital admission
4. Long term care plan developed and managed by the hospital dietitian.
5. Time allocation is determined by the needs of the patient but is usually in the range of 60-90 minutes per admission.

b) Ambulatory Model of Care ( AMoC):
Patients who receive the AMoC will receive the following services:
1. Full nutrition assessment as per departmental standards
2. Nutrition care plan developed and implemented during the hospital admission and immediate referral to the ambulatory care dietitian.
3. Minimal Dietary Education provided during hospital admission.
4. Long term care developed and managed by the ambulatory care dietitian.
5. Time allocation is determined by the AMoC dietitian but will be in the range of 3-6 monthly visits and these take approximately 30-60 minutes.

Process
1. During the intervention period the hospital dietitians providing the service to these wards will assess all patients referred using a standardised nutritional assessment tool. If the patient is identified as either at risk or malnourished they will be offered a six month check up after the leave hospital. If the patient accepts this service they will also be screened for eligibility into the study.
2. If patients are eligible for inclusion into the study they will be approached by staff member who does not work on these wards and they will discuss the research study and provide and invite then to participate. If they elect to participate their names will be given to the allocation officer.

3. Details on all patients who meet the eligibility criteria will be forwarded to the allocation officer (AO). This AO will randomly allocate these patients to one of the two models of care. Once allocation has been completed the hospital dietitian will be notified as to what model of care their patients will receive for the next six months.

4. If their patients are allocated the HMoC , they follow the inpatient HMoC protocol as outlined in a).

5. If their patients are allocated the AMoC they follow the inpatient AMoC protocol as outlined in b). This model of care requires the ward dietitian to liaise with ambulatory care dietitian during their patients’ admission in hospital. However, once the patient is discharged from hospital all care is managed by the ambulatory care dietitian.
Intervention code [1] 266946 0
Lifestyle
Intervention code [2] 267098 0
Behaviour
Comparator / control treatment
a) Hospital Model of Care ( HMoC):
Patients who receive the HMoC will receive the following services:
1. Full nutrition assessment as per departmental standards
2. Nutrition care plan developed and implemented during the hospital admission. Discretionary referral to the ambulatory care dietitian.
3. All the Dietary Education provided during hospital admission
4. Long term care plan developed and managed by the hospital dietitian.
Control group
Active

Outcomes
Primary outcome [1] 269180 0
Nutritional Status as measured by either the Subjective Global assessment tool ( for subjects less then 65 years of age)or the Mini NUtritional Assessment tool( for subjects 65 years of age or older)
Timepoint [1] 269180 0
Six months after initial recruitment
Secondary outcome [1] 279076 0
Dietary Variety Score
Timepoint [1] 279076 0
Six months
Secondary outcome [2] 279077 0
Length of stay in hospital
Timepoint [2] 279077 0
Six months
Secondary outcome [3] 279078 0
Patient satisfaction survey
Timepoint [3] 279078 0
six months
Secondary outcome [4] 279079 0
Total number of hospital days
Timepoint [4] 279079 0
six months
Secondary outcome [5] 279080 0
Total number of readmissions duringthe six months
Timepoint [5] 279080 0
Six months

Eligibility
Key inclusion criteria
All patients admitted to either the general medical or surgical wards who are
identified as at risk of malnutrition or malnourished and who will be returning to their home after discharge
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative patients
Those being discharged to a higher level of care facility then where they were preadmission

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study followed a stratified randomisation process. We used sealed opaque envelopes that each contained a number generated from a computerised randomised number generator program. A second separate random number generated list was created for those patients identified with a chronic airways limitation disease as per stratification randomisation procedure ( ).
A staff member, not involved directly in the study was assigned the role of Allocation Officer. Their task was to allocate on a daily basis during the week all eligible patients and notify the hospital dietitans and the community dietitans when appropriate. Any admissions on the weekend were randomised first thing on the following Monday morning. They also kept a record of patient details and assigned allocation in the study database. If the assignment was for the HMoC , this subject’s assessment details are returned to the hospital dietitian and if it was an AMoC assignment the community dietitian was provided with the patient details. Both groups received identical hospital care from the hospital dietitans but in addition to the usual care the AMoC group received co-ordinated after hospital care and this long term management program commenced as soon as they were admitted into the study. The community dietitan introduced themselves to the patients during their hospital admission and explained the nutrition care service and organized an after hospital appointment. This was arranged according to the needs of the patient i.e. in the patient’s home or in a local community health facility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list was created using a computerised randomised number generator program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a pragmatic RCT . All patients admitted to the general medical and surgical wards who were assessed as malnourished or at risk were eligible for the study. However they had to be returning to their home not higher level care facility.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
22/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4328 0
2500
Recruitment postcode(s) [2] 4329 0
2502

Funding & Sponsors
Funding source category [1] 267418 0
Self funded/Unfunded
Name [1] 267418 0
Marianna Milosavljevic
Country [1] 267418 0
Australia
Primary sponsor type
Hospital
Name
Wollongong Hospital
Address
Crown Street
Wollongong
2500
NSW
Country
Australia
Secondary sponsor category [1] 266669 0
None
Name [1] 266669 0
Address [1] 266669 0
Country [1] 266669 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269383 0
South Eastern Sydney University of Wollongong
Ethics committee address [1] 269383 0
Ethics committee country [1] 269383 0
Australia
Date submitted for ethics approval [1] 269383 0
20/05/2010
Approval date [1] 269383 0
21/07/2010
Ethics approval number [1] 269383 0
HE10/233

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32860 0
Address 32860 0
Country 32860 0
Phone 32860 0
Fax 32860 0
Email 32860 0
Contact person for public queries
Name 16107 0
Marianna Milosavljevic
Address 16107 0
Nutrition Department
Wollongong Hospital
Crown Street
Wollongong
NSW
2500
Country 16107 0
Australia
Phone 16107 0
61 2 4253 4545
Fax 16107 0
61 2 4253 4504
Email 16107 0
marianna.milosavljevic@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 7035 0
Marianna Milosavljevic
Address 7035 0
Nutrition Department
Wollongong Hospital
Crown Street
Wollongong
NSW
2500
Country 7035 0
Australia
Phone 7035 0
61 2 4253 4545
Fax 7035 0
61 2 4253 4504
Email 7035 0
marianna.milosavljevic@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo When patients received an extended community care ... [More Details]
Study results articleYes J Aging Res Clin Practice 2016;inpress Published ... [More Details]

Documents added automatically
No additional documents have been identified.