Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000760774
Ethics application status
Approved
Date submitted
21/06/2013
Date registered
8/07/2013
Date last updated
8/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hospital to home outreach for malnourished elders (HHOME): can better nutrition planning and follow-up improve nutrition and function in older medical patients?
Scientific title
Can enhanced nutritional discharge planning and follow-up care for malnourished older medical patients discharged to the community from hospital improve their nutritional and functional status compared to usual care?
Secondary ID [1] 281542 0
Nil
Universal Trial Number (UTN)
U1111-1136-7302
Trial acronym
HHOME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 287766 0
Condition category
Condition code
Diet and Nutrition 288109 288109 0 0
Other diet and nutrition disorders
Public Health 289792 289792 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-implementation group receives admission risk assessment screening (including the Malnutrition Screening Tool), inpatient care by a multidisciplinary team (MDT)which may include referral to a dietitian, and discharge planning by the MDT facilitated by the nursing case manager and/or discharge facilitator to ensure basic functional and nursing needs are met in the community (usual medical care).

Intervention is a complex system change developed in consultation with key hospital and community stakeholders (including education, enhanced interdisciplinary communication and use of an enhanced electronic referral system). Intervention extends from the inpatient stay to 6 weeks post-discharge and includes:
1. improve identification of malnourished elders as inpatients using the Malnutrition Screening Tool (baseline audit shows gaps in completion, accuracy and generation of referrals from this routine admission screen)
2. develop and implement an individual discharge nutrition care plan for all malnourished older patients in collaboration wtih nursing case manager and/or discharge facilitator, and communicate to GP
3. provide fortnightly telephone followup by dietitian for up to 6 weeks post discharge to assess knowledge, adherence to discharge plan and trouble-shoot new problems related to nutrition
4. enhance involvement of community service providers in nutrition-related tasks (eg shopping assistance, meal preparation) in the early post-hospital period

Interventions are supported by:
1. education sessions for medical unit dietitians (1-2 hours at implementation plus incorporated into position handover documentation), case managers (1 hour at tiem of implementation) and community care workers (1 hour 6 monthly)
2. written nutrition care summaries provided to patient and carer at discharge
3. nutrition discharge plan incorporated into hospital electronic referral tool
4. documentation of telephone followup occasions of service.

Process audits will include documentation of nutrition discharge plan, use of the electronic referral tool, frequency and outcomes of telephone followup, and rates and types of community service referral.
Intervention code [1] 286008 0
Treatment: Other
Comparator / control treatment
Pre-implementation (usual) nutrition care and discharge planning from medical ward as outlined above
Control group
Active

Outcomes
Primary outcome [1] 288310 0
Nutritional status measures using Mini Nutritional Assessment
Timepoint [1] 288310 0
6 weeks after hospital discharge compared to discharge
Primary outcome [2] 288311 0
Lean body mass measured using impedance scales
Timepoint [2] 288311 0
6 weeks after hosptial discharge compared to discharge
Secondary outcome [1] 299829 0
Functional status using modified Barthel index
Timepoint [1] 299829 0
6 weeks after hospital discharge compared to discharge
Secondary outcome [2] 299958 0
quality of life using AQOL-6D
Timepoint [2] 299958 0
6 weeks after hospital discharge
Secondary outcome [3] 303381 0
hospital utilisation (days in hospital)
Timepoint [3] 303381 0
12 weeks after hosptial discharge

Eligibility
Key inclusion criteria
Age 65 and older
Discharged from general medical units at Royal Brisbane or Prince Charles hospitals
Malnutrition screening tool (MST) score 2 or greater and/or body mass index <18.5
Consent to inclusion
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Discharged to residential aged care or inpatient rehabilitation facility
Life expectancy <6 months
Lives outside of district

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Control participants will be those enrolled prior to implementation of the new model of care (September 2012-January 2013 RBWH; July 2013-September 2013 TPCH))
Intervention participants will be those enrolled following introduction and maturation of the new model of care (October 2013-March 2014).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Post-intervention cohort compared to prospectively identified pre-intervention cohort
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between-group analyses will compare change in clinical outcomes (MNA, mass, MBI, QOL) from baseline to 6 week followup in post-intervention cohort receiveing active intervention versus pre-intervention cohort receiving usual care.
Total of 50 participants in each group (pre and post-implementation) will provide 80% power to demonstrate a clinically meaningful difference in the change of 2 units on MNA (asuming SD 2.5 ), 2kg weight (assuming SD 3kg ) and 5 units on MBI (asuming SD 9 ) (all estimates based on pilot data)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/09/2012
Actual
3/09/2012
Date of last participant enrolment
Anticipated
10/05/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1150 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 1151 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 6996 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 6997 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 286324 0
Government body
Name [1] 286324 0
Allied Health Workforce Advice and Coordination Unit
Country [1] 286324 0
Australia
Funding source category [2] 287489 0
Other Collaborative groups
Name [2] 287489 0
Australian Centre for Health Services Innovation (AUSHSI)
Country [2] 287489 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Department of Internal Medicine and Aged Care
Royal Brisbane and Womens' Hospital
Butterfield St
Herston Queensland 4029
Country
Australia
Secondary sponsor category [1] 285113 0
Hospital
Name [1] 285113 0
The Prince Charles Hospital
Address [1] 285113 0
Department of Internal Medicine
The Prince Charles Hospital
Rode Road
Chermside
Queensland 4032
Country [1] 285113 0
Australia
Other collaborator category [1] 277177 0
University
Name [1] 277177 0
University of Queensland
Address [1] 277177 0
Centre for Dietetic Research (C-DIET-R)
School of Human Movement Studies Bldg 26, Rm 407B
University of Queensland
Brisbane
Queensland 4072
Country [1] 277177 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288346 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 288346 0
Ethics committee country [1] 288346 0
Australia
Date submitted for ethics approval [1] 288346 0
Approval date [1] 288346 0
18/06/2012
Ethics approval number [1] 288346 0
HREC/12/QRBW/159

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

Contacts
Principal investigator
Name 34918 0
Prof Alison Mudge
Address 34918 0
Internal Medicine and Aged Care
3rd floor James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston Qld 4029
Country 34918 0
Australia
Phone 34918 0
61 7 36460854
Fax 34918 0
Email 34918 0
[email protected]
Contact person for public queries
Name 18165 0
Adrienne Young
Address 18165 0
Department of Nutrition and Dietetics
2nd floor, James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston Qld 4029
Country 18165 0
Australia
Phone 18165 0
61 7 36467997
Fax 18165 0
Email 18165 0
[email protected]
Contact person for scientific queries
Name 9093 0
Alison Mudge
Address 9093 0
Internal Medicine and Aged Care
3rd floor James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston Qld 4029
Country 9093 0
Australia
Phone 9093 0
61 7 36460854
Fax 9093 0
Email 9093 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.