Back to resultsSCAN Memory Program Evaluation Study (SMPES)
Primary Purpose
Dementia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dementia Care Management
Sponsored by
About this trial
This is an interventional health services research trial for Dementia focused on measuring Quality improvement, Quality of care, Health care utilization, Behavioral change
Eligibility Criteria
Inclusion Criteria: Health plan member eligibility includes having a visit-based ICD-9 diagnostic code for dementia or a dementia-specific medication (including donepezil, rivastigmine, galantamine, and memantine) within administrative data any time prior to data inquiry for potential subjects. The health plan member must have a caregiver who can communicate by telephone and though that person might also be a health plan member, health plan membership for caregivers is not required. All subjects must be living in the community and if in a nursing facility, this must be for rehabilitation or respite care but not for long term care. Caregivers must be able to communicate in English or Spanish.
Exclusion Criteria: Person with dementia whose potential participation is declined by their physician. Those who do not have a family or informal caregiver cannot participate and caregivers who do no have telephone access or the capacity to consent to research evaluation are excluded. Patients who reside in nursing facilities as permanent residents are not eligible.
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Sites / Locations
- Davis ResearchRecruiting
- VA Greater Los Angeles Healthcare SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Dementia care management
Usual care
Arm Description
Patients and family caregivers will be offered dementia care management, which includes detailed comprehensive assessment, education, counseling, referrals to community agencies, collaboration with medical providers and frequent telephone follow-up
Patients and care family care givers will receive usual support and medical care offered by the health plan.
Outcomes
Primary Outcome Measures
Guideline Adherence
Quality of care process measures will be examined that reflect practice guideline quality indicators measuring patient and caregiver assessment, treatment, education and support, and safety. Measures are collected at 9 and 18 months using caregiver surveys and medical record abstraction.
Program feasibility and fidelity
Formative Evaluation consisting of a series of stakeholder semi-structured interviews and data abstraction to monitor the activities of healthplan care managers will be collected at pre-specificed intervals and results will be provivided periodically to the healthplan for ongoing improvements in program delivery.
Healthcare utilization
Caregiver specific utilization including use of services that care managers may recommend to them and the dementia patient. Emergency department, hospitalization and ambulatory visits data will also be collected through administrative data and caregiver surveys.
Secondary Outcome Measures
Behavioral disturbance
Neuropsychiatric inventory questionnaire (NPI-Q)as a caregiver derived assessment on caregiver surveys conducted at baseline, 9 and 18 months.
Functional Status
Using an informant (caregiver)-based measure of 10 complex higher order activities using the Functional Activities Questionnaire (FAQ). This is a reliable measure of functional status in patients with dementia.
Quality of life
Patient health related quality of life (HRQOL) using the Health Utilities Index
Quality of Care
Using caregiver surveys, this will be measured with a 5-item scale from the Consumer Assessment of Health Plans Survey 2.0.
Caregiver self-efficacy
caregiver confidence using a 6-item measure that was utilized in prior care management clinical trials
Caregiver unmet need for assistance
a 2-item, 3-point scale for each covering general caregiveing - bathing, dressing, and transportation
Caregiver social support
This will be measured in caregiver surveys using a 5-item measure derived from the Medical Outcomes study Social Support Survey (MSSS).
Caregiver burden
The 22-item Burden Interview is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Each itme uses a 5-point scale (response set).
Caregiver depression
The Patient Health Questionnaire - Nine (PHQ-9) will be included in caregiver surveys at baseline, 9 and 18 months as a measure of depressive symptoms over the preceding 2 weeks.
Full Information
NCT ID
NCT01182987
First Posted
August 16, 2010
Last Updated
August 16, 2010
Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01182987
Brief Title
SCAN Memory Program Evaluation Study
Acronym
SMPES
Official Title
SCAN Memory Program Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The SCAN Memory Program Evaluation study is an evaluation of a randomized controlled trial intervention consisting of a care management program for cognitively-impaired health plan members and for their informal/family caregivers. The program includes collaboration between the health plan, partnering medical groups, and community organizations.
Program activities include: 1) telephonic-structured assessments with informal caregivers conducted by SCAN Memory Program care managers; 2) problem identification as a result of these assessments; and 3) pre-established protocols and procedures for problem resolution. ACCESS, the prototype for the SCAN Memory Program, was developed and tested in San Diego County and was very successful in helping affected patients and their caregivers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Quality improvement, Quality of care, Health care utilization, Behavioral change
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dementia care management
Arm Type
Active Comparator
Arm Description
Patients and family caregivers will be offered dementia care management, which includes detailed comprehensive assessment, education, counseling, referrals to community agencies, collaboration with medical providers and frequent telephone follow-up
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients and care family care givers will receive usual support and medical care offered by the health plan.
Intervention Type
Behavioral
Intervention Name(s)
Dementia Care Management
Intervention Description
The SCAN Memory Program is a care management program for cognitively-impaired SCAN members and for their informal/family caregivers. The program includes collaboration between SCAN Health Plan, partnering medical groups, and community organizations.
Program activities include: 1) telephonic-structured assessments with informal caregivers conducted by SCAN Memory Program care managers; 2) problem identification as a result of these assessments; and 3) pre-established protocols and procedures for problem resolution.
Primary Outcome Measure Information:
Title
Guideline Adherence
Description
Quality of care process measures will be examined that reflect practice guideline quality indicators measuring patient and caregiver assessment, treatment, education and support, and safety. Measures are collected at 9 and 18 months using caregiver surveys and medical record abstraction.
Time Frame
18 months of longer
Title
Program feasibility and fidelity
Description
Formative Evaluation consisting of a series of stakeholder semi-structured interviews and data abstraction to monitor the activities of healthplan care managers will be collected at pre-specificed intervals and results will be provivided periodically to the healthplan for ongoing improvements in program delivery.
Time Frame
6 to 18 months
Title
Healthcare utilization
Description
Caregiver specific utilization including use of services that care managers may recommend to them and the dementia patient. Emergency department, hospitalization and ambulatory visits data will also be collected through administrative data and caregiver surveys.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Behavioral disturbance
Description
Neuropsychiatric inventory questionnaire (NPI-Q)as a caregiver derived assessment on caregiver surveys conducted at baseline, 9 and 18 months.
Time Frame
9 months and 18 months
Title
Functional Status
Description
Using an informant (caregiver)-based measure of 10 complex higher order activities using the Functional Activities Questionnaire (FAQ). This is a reliable measure of functional status in patients with dementia.
Time Frame
9 and 18 months
Title
Quality of life
Description
Patient health related quality of life (HRQOL) using the Health Utilities Index
Time Frame
9 and 18 months
Title
Quality of Care
Description
Using caregiver surveys, this will be measured with a 5-item scale from the Consumer Assessment of Health Plans Survey 2.0.
Time Frame
9 and 18 months
Title
Caregiver self-efficacy
Description
caregiver confidence using a 6-item measure that was utilized in prior care management clinical trials
Time Frame
9 months and 18 months
Title
Caregiver unmet need for assistance
Description
a 2-item, 3-point scale for each covering general caregiveing - bathing, dressing, and transportation
Time Frame
9 months and 18 months
Title
Caregiver social support
Description
This will be measured in caregiver surveys using a 5-item measure derived from the Medical Outcomes study Social Support Survey (MSSS).
Time Frame
9 months and 18 months
Title
Caregiver burden
Description
The 22-item Burden Interview is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Each itme uses a 5-point scale (response set).
Time Frame
9 months and 18 months
Title
Caregiver depression
Description
The Patient Health Questionnaire - Nine (PHQ-9) will be included in caregiver surveys at baseline, 9 and 18 months as a measure of depressive symptoms over the preceding 2 weeks.
Time Frame
9 months and 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Health plan member eligibility includes having a visit-based ICD-9 diagnostic code for dementia or a dementia-specific medication (including donepezil, rivastigmine, galantamine, and memantine) within administrative data any time prior to data inquiry for potential subjects. The health plan member must have a caregiver who can communicate by telephone and though that person might also be a health plan member, health plan membership for caregivers is not required. All subjects must be living in the community and if in a nursing facility, this must be for rehabilitation or respite care but not for long term care. Caregivers must be able to communicate in English or Spanish.
Exclusion Criteria: Person with dementia whose potential participation is declined by their physician. Those who do not have a family or informal caregiver cannot participate and caregivers who do no have telephone access or the capacity to consent to research evaluation are excluded. Patients who reside in nursing facilities as permanent residents are not eligible.
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Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Chodosh, MD, MSHS
Phone
310-268-3361
Email
jchodosh@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Connor, RN, MBA, PhD
Phone
310-268-3975
Email
kiconnor@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD, MSHS
Organizational Affiliation
VA / UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davis Research
City
Calabasas
State/Province
California
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Kerns
Phone
818-223-4046
Email
jkerns@davisresearch.com
First Name & Middle Initial & Last Name & Degree
Nicole Cullen
Email
ncullen@davisresearch.com
First Name & Middle Initial & Last Name & Degree
Jason Kerns
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD, MSHS
Phone
310-268-3361
Email
jchodosh@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Karen Connor, RN, MBA, PhD
Phone
310-268-3975
Email
kiconnor@ucla.edu
12. IPD Sharing Statement
Learn more about this trial
SCAN Memory Program Evaluation Study
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