SCAN Memory Program Evaluation Study (SMPES)

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.

Study Overview

• Status: Unknown
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Dementia Care Management

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Calabasas, California, United States
      • Recruiting
      • Davis Research
      • Contact: Jason Kerns; Phone Number: 818-223-4046; Email: jkerns@davisresearch.com
      • Contact: Nicole Cullen; Email: ncullen@davisresearch.com
      • Sub-Investigator: Jason Kerns
    • Los Angeles, California, United States, 90073
      • Recruiting
      • VA Greater Los Angeles Healthcare System
      • Contact: Joshua Chodosh, MD, MSHS; Phone Number: 310-268-3361; Email: jchodosh@mednet.ucla.edu
      • Contact: Karen Connor, RN, MBA, PhD; Phone Number: 310-268-3975; Email: kiconnor@ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months of longer
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.	6 to 18 months
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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral disturbance	Neuropsychiatric inventory questionnaire (NPI-Q)as a caregiver derived assessment on caregiver surveys conducted at baseline, 9 and 18 months.	9 months 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.	9 and 18 months
Quality of life	Patient health related quality of life (HRQOL) using the Health Utilities Index	9 and 18 months
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.	9 and 18 months
Caregiver self-efficacy	caregiver confidence using a 6-item measure that was utilized in prior care management clinical trials	9 months and 18 months
Caregiver unmet need for assistance	a 2-item, 3-point scale for each covering general caregiveing - bathing, dressing, and transportation	9 months and 18 months
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).	9 months and 18 months
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).	9 months and 18 months
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.	9 months and 18 months

Collaborators and Investigators

• Sponsor: VA Greater Los Angeles Healthcare System
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Joshua Chodosh, MD, MSHS, VA / UCLA

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: August 16, 2010
• First Submitted That Met QC Criteria: August 16, 2010
• First Posted (Estimate): August 17, 2010

Study Record Updates

• Last Update Posted (Estimate): August 17, 2010
• Last Update Submitted That Met QC Criteria: August 16, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Quality improvement; Quality of care; Behavioral change; Health care utilization
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: SRC 09-002