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Trial registered on ANZCTR


Registration number
ACTRN12611000580976
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
6/06/2011
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Date results information initially provided
12/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of population-based disease management services (encompassing population analytics and telephone health coaching) on cost and hospitalisation for privately insured Australians with selected chronic conditions
Scientific title
A randomised control trial to evaluate the ability of a full service disease management program (encompassing population analytics and telephone health coaching), in comparison to simple program awareness building, to impact on subsequent health care costs and hospitalization for privately insured individuals with specific conditions and identified risks.
Secondary ID [1] 262323 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
CAPICHe
Costs to Australian Private Insurance - Coaching Health
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital, medical and prostheses costs borne by private insurers. 265848 0
Condition category
Condition code
Public Health 266001 266001 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Disease management services from Bupa Health Dialog including mailed program awareness notifications, tailored mailed educational material, tailored outreach material designed to encourage individuals with specific risks to talk with a Health Coach, outbound Health Coach outreach and follow-up calls (a minimum of two calls in first two months with no maximum number of calls being set), access on an inbound telephonic basis to Health Coaches, and mailed Health Coach selected educational and other material.

Duration of the intervention is for 12 months.
Intervention code [1] 264572 0
Prevention
Intervention code [2] 264573 0
Lifestyle
Intervention code [3] 264574 0
Behaviour
Comparator / control treatment
The control group will receive usual care unless they “opt-in” to receive health coaching.

Individuals randomly assigned to the Control Group will receive a letter outlining the service provided by BUPA Health Dialog. This letter will contain a phone number that participants may choose to ring should they wish to receive health coaching. Put simply, a health coach will not ring the participant directly.

If a participant assigned to the usual support group actively seeks health coach engagement, they will receive the same service provided to a participant assigned to the intervention group i.e. health coaching. Health coaches will have information available about the members derived from claims data and will have all the same educational resources at their disposal as they do for the intervention group. The health coaches will not have specific information that identifies control group members as such. Regardless of level of interaction with health coaches, all individuals assigned to the Control will be analysed as such.

It is worth noting that experience in other settings leads us to believe that the proportions of individuals who will actively seek Health Coach engagement with mailed outreach only will be very small, 3% or less. This will enable the differentiation of service levels between the intervention and control to be quite high. To ensure this is the case in the Australian setting, the number of members falling into this category will be reviewed on a six monthly basis.
Control group
Active

Outcomes
Primary outcome [1] 266744 0
The primary outcome measure is the total (non-maternity) cost for health fund members. Cost in this study is measured from the perspective of a private health insurer. That being, the total benefit paid calculated as the summation of hospital, medical (excluding Medicare component) and prostheses. Ancillary benefits will not be included as the role of the intervention in impacting on a range of benefits including dental and optical is not sufficiently well defined.
Timepoint [1] 266744 0
Monthly until paid claims have accrued for a full 12 month period after he or she is randomized into intervention and control.
Secondary outcome [1] 276287 0
Costs (non-maternity) per member in the intervention year by type of service.
Timepoint [1] 276287 0
Monthly until paid claims have accrued for a full 12 month period after he or she is randomized into intervention and control.
Secondary outcome [2] 276288 0
Rates of inpatient (non-maternity) hospitalisations in total in the intervention year. Outcome is assessed based on data linkage to private insurance claims.
Timepoint [2] 276288 0
12 months after he or she is randomized into intervention and control.
Secondary outcome [3] 276291 0
Same day non- maternity admission rates in the intervention year. Outcome is assessed based on data linkage to private insurance claims.
Timepoint [3] 276291 0
12 months after he or she is randomized into intervention and control.
Secondary outcome [4] 276292 0
Rates of non-maternity inpatient bed days in the intervention year. Outcome is assessed based on data linkage to private insurance claims.
Timepoint [4] 276292 0
12 months after he or she is randomized into intervention and control

Eligibility
Key inclusion criteria
Hold hospital cover with Bupa Australia (and have done so for at least 12 months continuously immediately prior to recruitment);

Have claims evidence of diagnosis of low back pain, diabetes, coronary artery disease, congestive heart failure, or chronic obstructive pulmonary disease;

Are the highest risk member of their household based on predicted risk; and

Have claims-based predicted risk level above a pre-determined threshold of 0.061. This is equivalent to a predicted cost for the following 12 months of $3,050 or more.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any individual who shares a household with a previously assigned study subject;

Individuals targeted by Bupa Health Dialog for similar services prior to study initiation (the COACH program for cardiovascular disease, the Genesis Heart Care program for quality improvement, and the Medibank Health Solutions Psychiatric Program);

Individuals involved in other potentially related chronic disease management programs through Bupa Australia prior to study initiation

Individuals with claims evidence prior to study initiation of: End Stage Renal Disease, AIDS, Haemophilia, Necrotizing fasciitis, organ transplant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are identified for enrolment each month based on qualification of inclusion criteria including a minimum risk score of 0.061. This is equivalent to a predicted cost for the following 12 months of $3,050 or more.

Risk scores are recalculated monthly based on new claims data that becomes available. Each month, a sample of subjects who meet the inclusion criteria are randomly selected using SAS Surveyselect procedure (SAS statistical software version 9.1.3). The proportion selected from those who meet the inclusion criteria is dependent on the capacity of the health coaches.

A total target population of at least 36,000 recruited; a sampling ratio of 4 intervention group participants for every one control group participants.

A stratified random allocation design is used to produce concordance between the intervention and control groups on baseline demographics and risk score. The strata selected for the randomisation are the five chronic conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was created using SAS Surveyselect procedure (SAS statistical software version 9.1.3) with the default simple random sampling option and stratified by chronic condition with a 4:1 allocation ratio to intervention
and control.

For each monthly batch of data, a seed value of nine digits was obtained by the statistician using random number generator with replacement from 0 to 9 for each of the nine digits. The Surveyselect procedure generates uniform random numbers using a prime modulus multiplicative generator with modulus 231 and multiplier 397204094. This means that it is very unlikely randomisation will be repeated.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 267109 0
Commercial sector/Industry
Name [1] 267109 0
BUPA Foundation (Australia)
Address [1] 267109 0
50 Bridge St
Sydney NSW 2000
Country [1] 267109 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BUPA Health Dialog
Address
801 Glenferrie Road
Hawthorne NSW 3122
Country
Australia
Secondary sponsor category [1] 264189 0
Commercial sector/Industry
Name [1] 264189 0
BUPA Australia
Address [1] 264189 0
50 Bridge St
Sydney NSW 2000
Country [1] 264189 0
Australia
Other collaborator category [1] 251989 0
University
Name [1] 251989 0
Griffith University
Address [1] 251989 0
School of Medicine
Logan Campus L03 2.43
Griffith University
Meadowbrook 4131
Queensland,
Country [1] 251989 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267047 0
GRIFFITH UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 267047 0
Research Ethics
Office for Research
Room 3.55
Building G39
Griffith University
Gold Coast Campus
Parklands, Qld 4222
Ethics committee country [1] 267047 0
Australia
Date submitted for ethics approval [1] 267047 0
06/04/2011
Approval date [1] 267047 0
08/04/2011
Ethics approval number [1] 267047 0
MED/12/11/HREC

Summary
Brief summary
A prospective study of 36,000 subjects will be undertaken to assess the impact of a chronic disease management services encompassing population analytics and telephone health coaching on health service utilisation and costs. Identification and predictive models based on health fund administrative data will be used to identify subjects with selected chronic conditions (congestive heart failure, coronary artery disease, diabetes, low back pain, coronary obstructive pulmonary disease) who have high likelihood of future health utilisation and costs in the subsequent twelve months. These subjects will be randomly assigned to either receive active outreach including outbound phone calls to encourage program participation or to receive only basic information about the program. Health coaching will be delivered over the phone, by specially trained and qualified nurses and tailored to the individual’s need. It aims to empower subjects through goal setting and support.
Trial website
Trial related presentations / publications
Byrnes JM, Goldstein S, Venator B, Pollicino C, Ng SK, Veroff D, Bennett C, Scuffham PA. The impact of population-based disease management services for selected chronic conditions: the Costs to Australian Private Insurance--Coaching Health (CAPICHe) study protocol. BMC Public Health 2012; 12(114):1-6
Public notes

Contacts
Principal investigator
Name 32603 0
Prof Paul Scuffham
Address 32603 0
Centre for Applied Health Economics, N78_2.42 Nathan Campus, Griffith University, Nathan, Qld 4111, Australia
Country 32603 0
Australia
Phone 32603 0
+61 (0)7 373 59132
Fax 32603 0
Email 32603 0
p.scuffham@griffith.edu.au
Contact person for public queries
Name 15850 0
Prof Professor Paul Scuffham
Address 15850 0
Centre for Applied Health Economics, N78_2.42 Nathan Campus, Griffith University, Nathan, Qld 4111, Australia
Country 15850 0
Australia
Phone 15850 0
+61 (0)7 373 59132
Fax 15850 0
Email 15850 0
p.scuffham@griffith.edu.au
Contact person for scientific queries
Name 6778 0
Prof Paul Scuffham
Address 6778 0
Centre for Applied Health Economics, N78_2.42 Nathan Campus, Griffith University, Nathan, Qld 4111, Australia
Country 6778 0
Australia
Phone 6778 0
+61 (0)7 373 59132
Fax 6778 0
Email 6778 0
p.scuffham@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data is commercial in confidence and owned by Bupa
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2353 0
Study protocol
Citation [1] 2353 0
Link [1] 2353 0
Email [1] 2353 0
Other [1] 2353 0
Study protocol published in BMC Public Health
https://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-12-114
Attachment [1] 2353 0
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 2354 0
Scuffham, P.A., Byrnes, J.M., Pollicino, C. et al. The Impact of Population-Based Disease Management Services on Health Care Utilisation and Costs: Results of the CAPICHe Trial.
J GEN INTERN MED, January 2019, Volume 34, Issue 1, pp 41–48

https://doi.org/10.1007/s11606-018-4682-5
https://link.springer.com/article/10.1007%2Fs11606-018-4682-5
Attachments [1] 2354 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary