SCAN Memory Program Evaluation Study (SMPES)
|ClinicalTrials.gov Identifier: NCT01182987|
Recruitment Status : Unknown
Verified August 2010 by VA Greater Los Angeles Healthcare System.
Recruitment status was: Recruiting
First Posted : August 17, 2010
Last Update Posted : August 17, 2010
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|
|Dementia||Behavioral: Dementia Care Management|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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 :||October 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||March 2012|
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.
- Guideline Adherence [ Time Frame: 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.
- Program feasibility and fidelity [ Time Frame: 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.
- Healthcare utilization [ Time Frame: 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.
- Behavioral disturbance [ Time Frame: 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.
- Functional Status [ Time Frame: 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.
- Quality of life [ Time Frame: 9 and 18 months ]Patient health related quality of life (HRQOL) using the Health Utilities Index
- Quality of Care [ Time Frame: 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.
- Caregiver self-efficacy [ Time Frame: 9 months and 18 months ]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 ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182987
|Contact: Joshua Chodosh, MD, MSHSfirstname.lastname@example.org|
|Contact: Karen Connor, RN, MBA, PhDemail@example.com|
|United States, California|
|Calabasas, California, United States|
|Contact: Jason Kerns 818-223-4046 firstname.lastname@example.org|
|Contact: Nicole Cullen email@example.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 firstname.lastname@example.org|
|Contact: Karen Connor, RN, MBA, PhD 310-268-3975 email@example.com|
|Principal Investigator:||Joshua Chodosh, MD, MSHS||VA / UCLA|