Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000214932
Ethics application status
Approved
Date submitted
24/02/2011
Date registered
28/02/2011
Date last updated
21/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Primary Care-Aging Services Partnership in Dementia Care
Scientific title
The effect of physician training and support, combined with community Alzheimer's disease and related disorders (ADRD) service provision, on physician rates of diagnosis and treatment of ADRD, referrals to community service providers, caregiver well-being and health service costs when compared to usual dementia care.
Secondary ID [1] 259672 0
Nil
Universal Trial Number (UTN)
U1111-1119-5749
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease and related disorders 261242 0
Condition category
Condition code
Neurological 259388 259388 0 0
Dementias
Public Health 259400 259400 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one-day intensive dementia care preceptorship for primary care physicians, including resource materials, newsletter updates and informal neurological consultations if desired.

Linkage to a direct, single entry point referral system through Project CARE ("Caregiver Alternatives to Running on Empty") via phoned or faxed referrals from the physicians trained at the preceptorship. This is a family consultant program for families caring for someone with dementia at home which will link families to a host of services including in home evaluations, respite care, legal services, etc. Services will be studied in the 10 months post-preceptorship but will be available indefinitely as the funding provides.
Intervention code [1] 258102 0
Treatment: Other
Comparator / control treatment
Usual dementia care (i.e. no primary care education, no access to Project CARE resources until after research period has ended, thus delayed intervention)
Control group
Active

Outcomes
Primary outcome [1] 262207 0
Number of patients diagnosed with Alzheimer's disease and related disorders (ADRD) via Medicare records
Timepoint [1] 262207 0
Within 10 months post-preceptorship
Primary outcome [2] 262208 0
Satisfaction with services and caregiving burden reported by family caregivers via a single 10 minute telephone interview.
Timepoint [2] 262208 0
Within 10 months post-preceptorship
Primary outcome [3] 262209 0
Health care costs as estimated via Medicare records
Timepoint [3] 262209 0
Within 10 months post-preceptorship
Secondary outcome [1] 273329 0
Measures of impact of physician training activities via physician-completed questionnaires created for this study
Timepoint [1] 273329 0
pre-training, immediately post-training, 6 months and 12 months post training
Secondary outcome [2] 273330 0
Referral and service provision rates for intervention physicians' ADRD patients via service provider records
Timepoint [2] 273330 0
Over the course of 12 months post-training

Eligibility
Key inclusion criteria
Providers must be active primary care MDs (with Internal Medicine or Family Medicine specialties) who practice in the 4 targeted counties (Alamance, Guilford, Rockingham and Caswell, NC) and provide care for large numbers of community dwelling older persons.

Patients and their caregivers (both interviewed and studied through existing Medicare data only) will be included if the patient is community-dwelling with the caregiver at the time of data request, are diagnosed with dementia (using a list of diagnostics codes for dementia), and are active patients of enrolled physicians who have been seen in the office post-preceptorship. For the caregivers, they must have English as their primary spoken language
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking caregivers will be excluded.

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)
A list of eligible physicians will be obtained by asking for recommendations of those who may be interested in dementia care from community leaders as well as via NC medical board website.

A statistician using computer generated randomization method will provide a list of intervention vs. delayed intervention physicians
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician using computer generated randomization method will provide a list of intervention vs. delayed intervention physicians. Recruitment of physicians will follow the random order of this list.
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
Recruiting
Date of first participant enrolment
Anticipated
15/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 3220 0
United States of America
State/province [1] 3220 0
NC

Funding & Sponsors
Funding source category [1] 258562 0
Government body
Name [1] 258562 0
US Administration on Aging
Country [1] 258562 0
United States of America
Primary sponsor type
Individual
Name
Philip Sloane, MD
Address
Sheps Center for Health Services Research
725 MLK Jr Blvd
Chapel Hill NC 27514
Country
United States of America
Secondary sponsor category [1] 257701 0
None
Name [1] 257701 0
Address [1] 257701 0
Country [1] 257701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260537 0
University of North Carolina Institutional Review Board
Ethics committee address [1] 260537 0
CB # 7097, Medical Building 52
105 Mason Farm Road
Chapel Hill NC 27599
Ethics committee country [1] 260537 0
United States of America
Date submitted for ethics approval [1] 260537 0
11/12/2010
Approval date [1] 260537 0
18/01/2011
Ethics approval number [1] 260537 0
1/10/2275

Summary
Brief summary
The purpose of this study is to compare an intervention consisting of an intensive Alzheimer’s Disease and related disorders (ADRD) training and continuing support for primary care providers as well as enhanced availability of community counseling and support resources for their referred patients and caregivers, to usual dementia care. Outcomes of interest include perceived knowledge and practice changes of physicians post-training, numbers of ADRD diagnoses and referrals, satisfaction with services and caregiving burden reported by caregivers, rates of hospitalization and nursing home placement of persons with ADRD and estimated costs of services received and health services utilized.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32258 0
Address 32258 0
Country 32258 0
Phone 32258 0
Fax 32258 0
Email 32258 0
Contact person for public queries
Name 15505 0
Christine Lathren
Address 15505 0
Sheps Center for Health Services Research
725 MLK Jr Blvd
Chapel Hill NC 27514
Country 15505 0
United States of America
Phone 15505 0
+ 1 919 966 7173
Fax 15505 0
Email 15505 0
[email protected]
Contact person for scientific queries
Name 6433 0
Philip Sloane
Address 6433 0
Sheps Center for Health Services Research
725 MLK Jr Blvd
Chapel Hill NC 27514
Country 6433 0
United States of America
Phone 6433 0
+ 1 919 966 7173
Fax 6433 0
Email 6433 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.