NCT01182987

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 17, 2010

Status Verified

August 1, 2010

Enrollment Period

2.2 years

First QC Date

August 16, 2010

Last Update Submit

August 16, 2010

Conditions

Keywords

Quality improvementQuality of careHealth care utilizationBehavioral change

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Behavioral disturbance

    9 months and 18 months

  • Functional Status

    9 and 18 months

  • Quality of life

    9 and 18 months

  • Quality of Care

    9 and 18 months

  • Caregiver self-efficacy

    9 months and 18 months

  • +4 more secondary outcomes

Study Arms (2)

Dementia care management

ACTIVE COMPARATOR

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

Usual care

NO INTERVENTION

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

Interventions

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.

Dementia care management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Davis Research

Calabasas, California, United States

RECRUITING

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

RECRUITING

MeSH Terms

Conditions

DementiaPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Joshua Chodosh, MD, MSHS

    VA / UCLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Chodosh, MD, MSHS

CONTACT

Karen Connor, RN, MBA, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 17, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

August 17, 2010

Record last verified: 2010-08

Locations