Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000499684
Ethics application status
Approved
Date submitted
28/04/2014
Date registered
12/05/2014
Date last updated
12/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aged Residential Care Healthcare Implementation Project (ARCHIP)
Scientific title
Multi-disciplinary provision of clinical coaching and support for staff and general practitioners providing medical care to residents of long-term care facilities in order to reduce acute hospitalisations - for stroke, COPD, pneumonia, congestive cardiac failure, and ischaemic heart disease.
Secondary ID [1] 284520 0
Nil
Universal Trial Number (UTN)
U1111-1156-0013
Trial acronym
ARCHIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Avoidable hospitalisations
 291721 0
Stroke 291722 0
Pneumonia 291723 0
Congestive cardiac failure 291724 0
COPD 291725 0
Ischaemic heart disease 291726 0
Death 291746 0
Condition category
Condition code
Infection 292097 292097 0 0
Other infectious diseases
Respiratory 292098 292098 0 0
Chronic obstructive pulmonary disease
Stroke 292099 292099 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a facility level study in which a multidisciplinary, generic intervention is targeted on long-term care facilities for older people, with the aim of reducing avoidable acute hospitalisations for five conditions: stroke, ischaemic heart disease, COPD, pneumonia and congestive cardiac failure.

The ARCHIP intervention is designed to provide intensive intervention and staff clinical coaching to improve assessment and care planning for those recently discharged from hospital with the ‘big 5’ diagnoses as described above. The Gerontology Nurse Specialist (GNS) will visit intervention facilities weekly for 3 months. Multidisciplinary team meetings will occur for approximately 20% to 25% of residents in each region. The facility will have direct telephone access to the geriatrician during normal business hours. Descriptions of each of the components of the intervention are described below:

a. Post Hospitalisation Care Planning Clinical Coaching for facility RN by the GNS:

Residents newly discharged from hospital will be targeted by the GNS as the subject of a clinical coaching to hone RN assessment and care planning skills. The following methods will be employed: Clinical Coaching, Case Study, Red Flag Recognition, Clinical Communication Skills, Advance Care Planning, GNS Care Coordination and Multi-disciplinary meetings.

b. Multidisciplinary Team Meetings (MDT) Processes and Procedures:

It is estimated that approximately 6 residents will be reviewed at a typical MDT meeting (up to 20%-25% of total residents in 1-4 MDT meetings). The criteria for selecting residents for discussion in the MDT meeting are as follows for residents with one of the ‘big 5’ diagnoses (as described above):

* New acute hospital admissions within the last month
* New admissions to the facility
* Those residents on 9 or more medications
* Any resident with important change(s) in physical or cognitive status since last review
* Any resident who has been subject to an incident report since last review

The GNS and facility clinical staff will create a list for the MDT using the above prioritised criteria. Residents will be reviewed in the order of highest priority. The GNS will finalise the list of residents to be discussed at the MDT in collaboration with the facility RN. The GNS with the RN will prepare a clinical review and assess each resident to be discussed, and work with senior nurse to contact family about MDT review.

MDT meeting participants will include:
* Resident’s General Practitioner (GP)
* Facility Senior Nurse
* DHB Geriatrician
* GNS
* Community pharmacist
* Other available and relevant health professionals will be invited to participate as needed and available such as: dietitians, physiotherapists, occupational therapists and/or social workers.
Intervention code [1] 289241 0
Treatment: Other
Comparator / control treatment
Facilities are their own controls in a before/after design using a stepped-wedge analysis.

National Ministry of Health databases will be used to :
a) identify residents in each participating facility in receipt of a government residential care subsidy over defined time period prior to and during the trial, and
b) identify all hospitalisations of those residents during the period for that facility, centred on the data at which the intervention began in each facility.
c) Rates of admissions post-commencement will be compared to rates post-intervention, for the five diagnoses of interest: stroke, ischaemic heart disease, COPD, pneumonia and congestive cardiac failure.
Control group
Historical

Outcomes
Primary outcome [1] 291972 0
Acute hospitalisations with a first diagnosis of one of those five conditions: stroke, ischaemic heart disease, COPD, pneumonia and congestive cardiac failure.
These will be established from electronic medical records submitted to the national hospitalisation and death record systems, through the DHB, and using the first ICD diagnosis code associated with each admission.
Timepoint [1] 291972 0
18 months
Secondary outcome [1] 307946 0
Mortality
Timepoint [1] 307946 0
18 months

Eligibility
Key inclusion criteria
All residents of long-term care facilities for older people located within the Waitemata DHB in Auckland, from a certain date (various by facility, rolling start) for a period of 18 months.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
LTC facilities will be selected on basis of several criteria, including admission history. Residents within selected facilities will be chosen by diagnoses (stroke, ischaemic heart disease, COPD, pneumonia and congestive cardiac failure) and by acuity criteria including recent hospitalisations.
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
Other
Other design features
Stepped wedge design, in which the clusters (here, facilities) switch treatment from control (usual support services) to experimental trial intervention at different time points (steps).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The trial is not a randomised controlled trial, but a translational study of an intervention previously trialed. That trial used 36 facilities, this will use about 24-30, and that determined largely by the resources available, knowing that before-after trials are considerably more efficient than randomised trials. No forma l power calculations were conducted for this study.

Stepped wedge design in which hospital admissions (for the five conditions described) and resident deaths will be monitored and expressed as a rate per bed-days of subsidised residents. We will also monitor RAC staff turnover.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2014
Actual
Date of last participant enrolment
Anticipated
5/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 6020 0
New Zealand
State/province [1] 6020 0
Auckland

Funding & Sponsors
Funding source category [1] 289129 0
Government body
Name [1] 289129 0
Health Research Council of New Zealand
Country [1] 289129 0
New Zealand
Funding source category [2] 289136 0
Government body
Name [2] 289136 0
Waitemata District Health Board
Country [2] 289136 0
New Zealand
Funding source category [3] 289137 0
Other Collaborative groups
Name [3] 289137 0
Waitemata Primary Health Organisation
Country [3] 289137 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287803 0
Government body
Name [1] 287803 0
Waitemata District Health Board
Address [1] 287803 0
Private Bag 93-503
Takapuna
AUCKLAND 0740
Country [1] 287803 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290908 0
HDEC Auckland
Ethics committee address [1] 290908 0
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 290908 0
New Zealand
Date submitted for ethics approval [1] 290908 0
Approval date [1] 290908 0
22/01/2014
Ethics approval number [1] 290908 0
13/NTB/172

Summary
Brief summary
Older people who are residents of rest homes and private hospitals are commonly admitted acutely to public hospitals because of potentially avoidable deterioration in medical conditions such as heart diseases, chronic lung disease and stroke. Such acute hospital admissions commonly have adverse consequences for the older person.
The current study will provide added intervention (nurses, geriatricians, pharmacists) working with the rest home/private staff and general practitioners, with the aim of preventing such avoidable acute hospital admissions for these five medical conditions.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 47918 0
Prof Martin J Connolly
Address 47918 0
University of Auckland Department of Geriatric Medicine
C/- Waitemata District Health Baord
North Shore Hospital
PO Box 93 503
Takapuna
Auckland 0740
Country 47918 0
New Zealand
Phone 47918 0
+6494427146
Fax 47918 0
+6494427166
Email 47918 0
[email protected]
Contact person for public queries
Name 47919 0
Prof Martin J Connolly
Address 47919 0
University of Auckland Department of Geriatric Medicine
C/- Waitemata District Health Baord
North Shore Hospital
PPo Box 93 503
Takapuna
Auckland 0740
Country 47919 0
New Zealand
Phone 47919 0
+6494427146
Fax 47919 0
+6494427166
Email 47919 0
[email protected]
Contact person for scientific queries
Name 47920 0
Prof Martin J Connolly
Address 47920 0
University of Auckland Department of Geriatric Medicine
C/- Waitemata District Health Baord
North Shore Hospital
PPo Box 93 503
Takapuna
Auckland 0740
Country 47920 0
New Zealand
Phone 47920 0
+6494427146
Fax 47920 0
+6494427166
Email 47920 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
EmbaseReducing emergency presentations from long-term care: A before-and-after study of a multidisciplinary team intervention.2018https://dx.doi.org/10.1016/j.maturitas.2018.08.014
N.B. These documents automatically identified may not have been verified by the study sponsor.