SMPES: SCAN Memory Program Evaluation Study

Sponsor
VA Greater Los Angeles Healthcare System (U.S. Fed)
Overall Status
Unknown status
CT.gov ID
NCT01182987
Collaborator
University of California, Los Angeles (Other)
500
2
2
29
250
8.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dementia Care Management
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
SCAN Memory Program Evaluation Study
Study Start Date :
Oct 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

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.

No Intervention: Usual care

Patients and care family care givers will receive usual support and medical care offered by the health plan.

Outcome Measures

Primary Outcome Measures

  1. Guideline Adherence [18 months of longer]

    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.

  2. Program feasibility and fidelity [6 to 18 months]

    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.

  3. Healthcare utilization [18 months]

    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

  1. Behavioral disturbance [9 months and 18 months]

    Neuropsychiatric inventory questionnaire (NPI-Q)as a caregiver derived assessment on caregiver surveys conducted at baseline, 9 and 18 months.

  2. Functional Status [9 and 18 months]

    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.

  3. Quality of life [9 and 18 months]

    Patient health related quality of life (HRQOL) using the Health Utilities Index

  4. Quality of Care [9 and 18 months]

    Using caregiver surveys, this will be measured with a 5-item scale from the Consumer Assessment of Health Plans Survey 2.0.

  5. Caregiver self-efficacy [9 months and 18 months]

    caregiver confidence using a 6-item measure that was utilized in prior care management clinical trials

  6. Caregiver unmet need for assistance [9 months and 18 months]

    a 2-item, 3-point scale for each covering general caregiveing - bathing, dressing, and transportation

  7. Caregiver social support [9 months and 18 months]

    This will be measured in caregiver surveys using a 5-item measure derived from the Medical Outcomes study Social Support Survey (MSSS).

  8. Caregiver burden [9 months and 18 months]

    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).

  9. Caregiver depression [9 months and 18 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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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Contacts and Locations

Locations

Site City State Country Postal Code
1 Davis Research Calabasas California United States
2 VA Greater Los Angeles Healthcare System Los Angeles California United States 90073

Sponsors and Collaborators

  • VA Greater Los Angeles Healthcare System
  • University of California, Los Angeles

Investigators

  • Principal Investigator: Joshua Chodosh, MD, MSHS, VA / UCLA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01182987
Other Study ID Numbers:
  • SRC 09-002
First Posted:
Aug 17, 2010
Last Update Posted:
Aug 17, 2010
Last Verified:
Aug 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2010