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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
  Purpose

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 Intervention
Dementia
Behavioral: Dementia Care Management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: SCAN Memory Program Evaluation Study

Resource links provided by NLM:


Further study details as provided by VA Greater Los Angeles Healthcare System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: October 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182987

Contacts
Contact: Joshua Chodosh, MD, MSHS 310-268-3361 jchodosh@mednet.ucla.edu
Contact: Karen Connor, RN, MBA, PhD 310-268-3975 kiconnor@ucla.edu

Locations
United States, California
Davis Research Recruiting
Calabasas, California, United States
Contact: Jason Kerns    818-223-4046    jkerns@davisresearch.com   
Contact: Nicole Cullen       ncullen@davisresearch.com   
Sub-Investigator: Jason Kerns         
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Joshua Chodosh, MD, MSHS    310-268-3361    jchodosh@mednet.ucla.edu   
Contact: Karen Connor, RN, MBA, PhD    310-268-3975    kiconnor@ucla.edu   
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
University of California, Los Angeles
Investigators
Principal Investigator: Joshua Chodosh, MD, MSHS VA / UCLA
  More Information

No publications provided

Responsible Party: Joshua Chodosh, MD, MSHS / Principal Investigator, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT01182987     History of Changes
Other Study ID Numbers: SRC 09-002
Study First Received: August 16, 2010
Last Updated: August 16, 2010
Health Authority: United States: Federal Government

Keywords provided by VA Greater Los Angeles Healthcare System:
Quality improvement
Quality of care
Health care utilization
Behavioral change

ClinicalTrials.gov processed this record on November 20, 2014