Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001332314
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
18/09/2017
Date last updated
18/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A gerontology nurse specialist role for high risk older people in the community
Scientific title
The effect of a primary care gerontology nurse specialist role for high risk older people on healthcare utilisation: a quasi-experimental study.
Secondary ID [1] 292845 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression
 304700 0
memory problems 304701 0
short of breath on exertion 304702 0
falls 304704 0
Condition category
Condition code
Mental Health 304012 304012 0 0
Depression
Respiratory 304055 304055 0 0
Other respiratory disorders / diseases
Neurological 304056 304056 0 0
Dementias
Injuries and Accidents 304059 304059 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was a quasi-experimental design. An innovative intervention model was instigated within the primary healthcare setting comprising a screening tool to identify high risk older people with succeeding Gerontology Nurse Specialist (GNS) assessment and care coordination.
The intervention model of care was initiated in two urban primary healthcare practices. Older adults aged 75 years or greater and enrolled in one of the primary healthcare practices were eligible for participation in the study. Older adults were excluded if they were residing in a residential care facility at the start of the study or if at the time they were receiving care under the local hospital-based GNS team.
The Brief Risk Identification for Geriatric Health Tool (BRIGHT) was used to case find high risk older people. This screening tool is a straightforward 11 item self-administered survey. Each of the 11 questions has a “yes” or “no” answer and represents one count. The scores are summed with a total of three or higher indicating high risk of health and/or functional decline. The BRIGHT screen was posted, with a return self-addressed paid envelope, to older people who met eligibility criteria in the intervention group. If the posted BRIGHT screen was not completed and returned within two weeks, the GNS was to undertake follow-up phone calls to administer the BRIGHT over the phone. Subsequently, within one month of receiving the returned BRIGHT all older people deemed high risk (BRIGHT score of 3 or greater) were visited by the GNS in their own home where a Comprehensive Geriatric Assessment (CGA) was undertaken. This assessment would take approximately 1-1.5hrs. General Practitioners (GPs) could also directly refer older people they were concerned about to the GNS for assessment.
The CGA was to be undertaken within two weeks of the returned BRIGHT screen, in the older person’s home at a mutually convenient time. A mixture of specific questions and standardised assessment tools were used to holistically and comprehensively assess the domains of physical health, functional ability, cognitive impairment, depression, pain, medications and social issues. Following this assessment, the GNS provided a summary of the older person’s current issues and developed an individualised intervention plan, this varied depending on personalised need, although often included education, referrals and ongoing GNS input and follow up. This summary was sent to the GP.
The GNS was located within the primary healthcare organisation as well as integrating with hospital based specialist gerontology teams. These specialist teams provided the GNS with mentorship and increased expertise through peer clinical education sessions and weekly case conferences. The combination of primary and secondary care engagement afforded the GNS access to primary healthcare practice and hospital patient databases as well as the ability to simultaneously coordinate with community and specialist hospital services.
Intervention code [1] 299103 0
Prevention
Intervention code [2] 299104 0
Treatment: Other
Comparator / control treatment
The comparison group received usual care. Usual care was defined as the GP determining GNS input was required. The GP would then refer the older person to the hospital based GNS team as per usual referral and practice procedures. The comparison group encompassed three primary healthcare practices with older people of comparable socioeconomic status, ethnicity and geographical location. Older adults aged 75 years or greater and enrolled in one of the primary healthcare practices were eligible for participation in the study.
Control group
Active

Outcomes
Primary outcome [1] 303346 0
Acute hospitalisations as assessed by review of medical records in an electronic records system
Timepoint [1] 303346 0
One year pre and post start of the intervention
Secondary outcome [1] 338710 0
Hospital re-admissions as assessed by review of medical records in an electronic records system
Timepoint [1] 338710 0
One year pre and post intervention
Secondary outcome [2] 338711 0
hospital length of stay as assessed by review of medical records in an electronic records system
Timepoint [2] 338711 0
one year pre and post intervention
Secondary outcome [3] 338713 0
emergency department presentations as assessed by review of medical records in an electronic records system
Timepoint [3] 338713 0
one year pre and post intervention
Secondary outcome [4] 338714 0
residential care admissions as assessed by review of medical records in an electronic records system
Timepoint [4] 338714 0
one year pre and post intervention
Secondary outcome [5] 338715 0
community contacts as assessed by review of medical records in an electronic records system
Community contacts include the following:
District Nurse
Physiotherapy
Occupational therapy
Gerontology Clinical Nurse Specialist
Respiratory Clinical Nurse Specialist
Social work
Dietetics
Speech Language Therapy
Ostomy nurse
Continence Nurse
Timepoint [5] 338715 0
one year pre and post intervention

Eligibility
Key inclusion criteria
Older adults aged 75 years or greater and enrolled in one of the primary healthcare practices were eligible for participation in the study.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Older adults were excluded if they were residing in a residential care facility at the start of the study or if at the time they were receiving care under the local hospital-based GNS team.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No power sample calculations were made. Two healthcare practices were to receive the intervention and to ensure the same or greater numbers for comparison, three comparable healthcare practices were selected for the comparison/usual care group.

Data was automatically extracted from an electronic records system into a Microsoft® Excel database which was then imported to SAS/STAT® software for analysis. The data were summarised using descriptive statistical methods detailing frequency counts, percentages and mean scores as appropriate. Student’s t tests were used for comparisons of continuous data and Chi-square tests for comparisons of categorical data. Relative risks and 95% confidence intervals were calculated for the secondary outcomes (residential care admission and community contacts) when comparing the intervention and comparison groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
31/08/2012
Date of last data collection
Anticipated
Actual
31/08/2013
Sample size
Target
1300
Accrual to date
Final
1400
Recruitment outside Australia
Country [1] 9197 0
New Zealand
State/province [1] 9197 0
Auckland

Funding & Sponsors
Funding source category [1] 297478 0
University
Name [1] 297478 0
The University of Auckland new staff Faculty Research and Development Fund
Country [1] 297478 0
New Zealand
Primary sponsor type
Individual
Name
Anna King
Address
The University of Auckland, 85 Park Rd, Grafton, Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country
New Zealand
Secondary sponsor category [1] 296474 0
None
Name [1] 296474 0
Address [1] 296474 0
Country [1] 296474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298580 0
Northern X Regional New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 298580 0
Ethics committee country [1] 298580 0
New Zealand
Date submitted for ethics approval [1] 298580 0
06/06/2012
Approval date [1] 298580 0
11/06/2012
Ethics approval number [1] 298580 0
NTX/12/EXP/123

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2049 2049 0 0
/AnzctrAttachments/373622-Ehtics approval.pdf (Ethics approval)
Attachments [2] 2050 2050 0 0
/AnzctrAttachments/373622-Ethics approval letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 77546 0
Dr Anna King
Address 77546 0
The University of Auckland
85 Park Rd, Grafton, Auckland
Private Bag 920129, Auckland 1142
New Zealand
Country 77546 0
New Zealand
Phone 77546 0
+64 9 9231537
Fax 77546 0
Email 77546 0
[email protected]
Contact person for public queries
Name 77547 0
Anna King
Address 77547 0
The University of Auckland
85 Park Rd, Grafton, Auckland
Private Bag 920129, Auckland 1142
New Zealand
Country 77547 0
New Zealand
Phone 77547 0
+64 9 9231537
Fax 77547 0
Email 77547 0
[email protected]
Contact person for scientific queries
Name 77548 0
Anna King
Address 77548 0
The University of Auckland
85 Park Rd, Grafton, Auckland
Private Bag 920129, Auckland 1142
New Zealand
Country 77548 0
New Zealand
Phone 77548 0
+64 9 9231537
Fax 77548 0
Email 77548 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
SourceTitleYear of PublicationDOI
EmbaseThe effect of a gerontology nurse specialist for high needs older people in the community on healthcare utilisation: a controlled before-after study.2018https://dx.doi.org/10.1186/s12877-018-0717-3
N.B. These documents automatically identified may not have been verified by the study sponsor.