SCAN Memory Program Evaluation Study (SMPES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by VA Greater Los Angeles Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT01182987
First received: August 16, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

August 16, 2010
August 16, 2010
October 2009
December 2011   (final data collection date for primary outcome measure)
  • Guideline Adherence [ Time Frame: 18 months of longer ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 to 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.
Same as current
No Changes Posted
  • Behavioral disturbance [ Time Frame: 9 months and 18 months ] [ Designated as safety issue: No ]
    Neuropsychiatric inventory questionnaire (NPI-Q)as a caregiver derived assessment on caregiver surveys conducted at baseline, 9 and 18 months.
  • Functional Status [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
    Patient health related quality of life (HRQOL) using the Health Utilities Index
  • Quality of Care [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months and 18 months ] [ Designated as safety issue: No ]
    caregiver confidence using a 6-item measure that was utilized in prior care management clinical trials
  • Caregiver unmet need for assistance [ Time Frame: 9 months and 18 months ] [ Designated as safety issue: No ]
    a 2-item, 3-point scale for each covering general caregiveing - bathing, dressing, and transportation
  • Caregiver social support [ Time Frame: 9 months and 18 months ] [ Designated as safety issue: No ]
    This will be measured in caregiver surveys using a 5-item measure derived from the Medical Outcomes study Social Support Survey (MSSS).
  • Caregiver burden [ Time Frame: 9 months and 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months and 18 months ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
SCAN Memory Program Evaluation Study
SCAN Memory Program Evaluation Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Dementia
Behavioral: Dementia Care Management

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.

  • Active Comparator: Dementia care management
    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
    Intervention: Behavioral: Dementia Care Management
  • No Intervention: Usual care
    Patients and care family care givers will receive usual support and medical care offered by the health plan.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2012
December 2011   (final data collection date for primary outcome measure)

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.

-

Both
18 Years and older
No
Contact: Joshua Chodosh, MD, MSHS 310-268-3361 jchodosh@mednet.ucla.edu
Contact: Karen Connor, RN, MBA, PhD 310-268-3975 kiconnor@ucla.edu
United States
 
NCT01182987
SRC 09-002
No
Joshua Chodosh, MD, MSHS / Principal Investigator, VA Greater Los Angeles Healthcare System
VA Greater Los Angeles Healthcare System
University of California, Los Angeles
Principal Investigator: Joshua Chodosh, MD, MSHS VA / UCLA
VA Greater Los Angeles Healthcare System
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP