Partners in Dementia Care (PDC)

This study has been completed.
Sponsor:
Collaborators:
Benjamin Rose Institute
Alzheimer's Association
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00291161
First received: February 10, 2006
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

Background: Partners in Dementia Care (PDC) is a care coordination and support service intervention for veterans with dementia and their family caregivers, delivered through partnerships between VA medical centers and local Alzheimer's Association Chapters. PDC was created from seven years of research and development, and was designed to be a feasible and practical intervention to integrate health, community, and support services. PDC has a standardized protocol for care coordination and support services, including guidelines for care plan assessment, care plan development and implementation, ongoing monitoring, and reassessment. It also offers a structured training curriculum for providers and an operations manual for uniform implementation.

Objectives: The primary objective of this investigation is to rigorously test the impact of PDC on a number of outcomes for veterans with dementia, family caregivers, and health care providers. Within VA Medical Centers, the focus will be on improving dementia care in primary care clinics, including geriatrics. Two specific research objectives and corresponding hypotheses will be addressed: 1. To test the impact of PDC on three categories of outcomes: psychosocial well-being outcomes (patient and caregiver effects); health care service use (patient effects only); and health care cost (patient effects only). HI:PDC, compared to usual care, will improve psychosocial well-being, including depression, health status, adequacy of care, and quality of care for patients with dementia and their caregivers. H2:PDC, compared to usual care, will reduce health care service use for patients with dementia, including hospital admissions, emergency department visits, nursing home admissions, and physician visits. H3:PDC is preferred to usual care based on cost-effectiveness and cost-benefit analyses. H4:The PDC intervention will be more effective in improving psychosocial well-being and reducing health care service use for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors). 2. To evaluate the impact of PDC on role and intra-psychic strains caused by dementia and its care (patient and caregiver effects). H5a:PDC, compared to usual care, will decrease patient role and intra-psychic strain, including embarrassment about the illness, emotional strain, relationship strain, and social isolation. H5b:PDC, compared to usual care, will decrease caregiver role and intra-psychic strain, including role captivity, work care-related strain, relationship strain, emotional and physical health deterioration, and caregiving efficacy. H6:The PDC intervention will be more effective in decreasing role and intra-psychic strains for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors). If effective, the long-term objective is to implement PDC in a regional, QUERI-like demonstration (Quality Enhancement Research Initiative), involving 30-40 VA medical centers. Additionally, the PDC approach will be adapted for other chronic conditions (e.g., heart disease, COPD, diabetes).

Methods: The proposed study is a 55-month, controlled trial of Partners in Dementia Care. The PDC intervention will be implemented in two intervention sites and three comparison sites that are matched on organizational, provider, and patient characteristics.

Findings: No findings at this time.


Condition Intervention
Dementia
Alzheimer Disease
Behavioral: Care Coordination in Primary Care
Behavioral: Care Coordination in Alz. Association

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Partners in Dementia Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Psychosocial well-being (patient and caregiver), health care service use (patient only), and health care cost (patient only) [ Time Frame: A T1 baseline interview will be conducted upon enrollment in the study. T2 interviews are conducted 6 months after the T1 interview. T3 interviews are conducted 6 months after the T2 interviews. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Role and intra-psychic strain [ Time Frame: A T1 baseline interview will be conducted upon enrollment in the study. T2 interviews are conducted 6 months after the T1 interview. T3 interviews are conducted 6 months after the T2 interviews. ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: December 2006
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1

Organized around the Chronic Care Model, the major components of the PDC intervention consist of:

  1. Assessment of care needs, both medical and non-medical, for patients and caregivers;
  2. Development of a care plan that addresses the medical and non-medical care needs of patients and caregivers;
  3. on-going monitoring of the status, progress, and barriers encountered when implementing/completing the steps of the care plan and on-going monitoring of new care needs that arise for patients and caregivers; and
  4. Reassessment of care needs for patients and caregivers at regular 6-month intervals and/or points of significant change.
Behavioral: Care Coordination in Primary Care

Care coordination within the primary care setting is facilitated by the VA Dementia care coordinator (VA DCC) that is with the study. The role of the VA DCC includes conducting initial assessments with the subject and caregiver that leads to:

Arranging for further assessment or attention from VA health care system/providers about dementia related concerns or about co-morbid health issues; for example: VA driving evaluation, congestive heart failure medication adherence; Ensuring education is provided about particular health, safety issues; Following up with patient/caregiver on health promoting activities he/she is committed to do; and Sharing care plan actions/outcomes with other VA providers as agreed upon by patient.

Behavioral: Care Coordination in Alz. Association
Care coordination with the Alzheimer's Association is facilitated by the Alzheimer's Association Care Coordinator (AA CC) that is located within the local chapter but is a part of the study. The role of the AA CC includes conducting follow up assessments with the subject and caregiver that leads to: Facilitating referral and linkage of the veteran/family caregiver to all relevant chapter services and supports; Linking veterans/families to further assessment or attention from community care providers; for example: help with respite services, legal referrals, etc.; Ensuring education is provided about emotional needs, behavior problems, etc. issues; and Following up with patient/caregiver on self-care activities he/she committed to do.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dementia Diagnosis
  • veteran
  • reside outside of a long-term care facility
  • live within local Alzheimer Association chapter service of Houston, Oklahoma City, Boston, or Providence

Exclusion Criteria:

  • Live in long-term care
  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: NCT00291161

Locations
United States, Massachusetts
VA Boston Health Care System, Jamaica Plain
Boston, Massachusetts, United States, 02130
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States, 02301
United States, Oklahoma
Oklahoma City, OK
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908-4799
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Benjamin Rose Institute
Alzheimer's Association
Investigators
Principal Investigator: Mark E. Kunik, MD MPH Michael E DeBakey VA Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00291161     History of Changes
Other Study ID Numbers: IIR 04-238
Study First Received: February 10, 2006
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Delivery of Health Care, Integrated
United States Department of Veterans Affairs
Dementia
Patient Care Management

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014