Partners in Dementia Care

Alzheimer Disease Clinical Trial

— PDC  

Official title:

Partners in Dementia Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291161
• Other study ID #: IIR 04-238
• Status: Completed
• Phase: N/A
• First received: February 10, 2006
• Last updated: August 6, 2014
• Start date: December 2006
• Est. completion date: February 2011

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background:

Dementia affects the entire family by negatively impacting multiple domains including physical health, emotional health, social relationships, and legal and financial issues (Gurland, 1980; Kunik, Snow, Molinari, Menke, Souchek, Sullivan et al, 2003; Schulz, Visintainer, & Williamson, 1990; Wright, Clipp, & George, 1993). Particularly challenging is accessing the range of services needed to address the care needs of both the individual with dementia and the primary family caregiver. Common issues include: obtaining adequate diagnostic testing; understanding treatment options and medications; difficulties with memory and behavioral symptoms; and care- and illness-related strain (Mitnick, Leffler, & Hood, 2010). Additionally, many unmet care needs are the result of service fragmentation and inadequate communication among different medical providers, medical providers and consumers, and medical providers and community services (Reuben, Levin, Frank, 2009).

Built upon two prior studies: the Cleveland Alzheimer's Managed Care Demonstration (Bass, Clark, Looman, McCarthy, & Eckert, 2003) and the Chronic Care Networks for Alzheimer's Disease (CCN/AD) (Maslow & Bass, 2003; Maslow & Selstad, 2001), PDC was a 5-year research investigation that tested the effectiveness of a telephone-based, innovative care-coordination intervention designed to address the unmet care needs of Veterans with dementia and their family caregivers across all dementia stages. PDC was implemented through formal partnerships between the VA medical centers and local Alzheimer's Association (AA) chapters. Essential features of PDC included: 1) formal partnerships between VA medical centers and Alzheimer's Association Chapters; 2) a multidimensional assessment and treatment approach, 3) ongoing monitoring and long-term relationships with families; and 4) a computerized information system to guide service delivery and fidelity monitoring. For a complete description of the PDC intervention protocol please see Judge, Bass, Snow, Wilson, Morgan, Looman, McCarthy, and Kunik (2010).

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 healthcare 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); healthcare service use (patient effects only); and health care cost (patient effects only).

Hypothesis 1: PDC, compared with 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.

Hypothesis 2: PDC, compared with usual care, will reduce healthcare service use for patients with dementia, including hospital admissions, emergency department visits, nursing home admissions, and physician visits.

Hypothesis 3: PDC is preferred to usual care, based on cost-effectiveness and cost-benefit analyses.

Hypothesis 4: The PDC intervention will be more effective than usual care 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).

Hypothesis 5a: PDC, compared with usual care, will decrease patient role and intra-psychic strain, including embarrassment about the illness, emotional strain, relationship strain, and social isolation.

Hypothesis 5b: PDC, compared with 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.

Hypothesis 6: The PDC intervention will be more effective than usual care 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, Quality Enhancement Research Initiative (QUERI)-like demonstration involving 30 to 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 was a 55-month, controlled trial of PDC. The project was conducted at two intervention sites and three comparison sites matched on organizational, provider, and patient characteristics.

Partners in Dementia Care was compared to usual care. Both groups received educational materials about dementia at the start.

PDC Intervention The Chronic Care Model (Bodenheimer, Wagner, & Grumbach, 2002; Bodenheimer, Wagner, & Grumbach, 2002) was used as an overarching framework to implement PDC and included the following components: 1) Formal linkages between medical centers (the VA) and community agencies (the Alzheimer's Association); 2) Organizational support from key leaders and broad-based training about PDC; 3) Delivery system redesign and decision support systems; 4) Self-management of dementia as outlined by the PDC intervention protocol; 5) The development of the PDC Care Coordination Information System (CCIS) as the clinical information system.

PDC had four primary ways of assisting families: 1) providing disease-related education and information; 2) offering emotional support and coaching; 3) linking families to medical and non-medical services and resources; and 4) mobilizing and organizing the informal care network. Two key staff members implemented the intervention: a VA Dementia Care Coordinator (VA DCC) in VA medical centers and an Alzheimer's Association Care Consultant (AA CC) in Alzheimer's Association Chapters. VA DCCs primarily focused on veterans' medical and non-medical needs and assisted families with effectively using VA resources; AA CCs primarily focused on needs of informal caregivers such as care-related strain and accessing non-VA resources. The intervention protocol consisted of: 1) Assessment of Care Needs across medical and non-medical care issues that addressed 23 domains for Veterans and 14 domains for caregivers; 2) Development of Care Goals that matched the priorities of Veterans and caregivers; 3) Development of Action Steps which were concrete behavioral tasks intended to help families move toward goal achievement (e.g., individual responsible for completing each task, expected completion date); 4) On-going Monitoring of Action Steps on a regular basis to ensure timely completion of tasks, address potential barriers, modify or add action steps, and identify new goals.

Analytic Plan With one exception, measures of "objective" characteristics, including community and support-service use, service knowledge, number of informal helpers, and Veterans' impairments, were based on information reported by caregivers. The one exception was a measure of impairment based on scores from a standardized mental status test that was administered to Veterans over the telephone (i.e., the Blessed Orientation-Memory-Concentration Test; Katzman et al., 1983). Additionally, a small number of Veterans (approximately 5%) with mild dementia did not have a caregiver; "objective" characteristics for these individuals were self-reported by the Veteran. Information used to construct measures of "subjective" characteristics, such as feelings about or perceptions of the quality of care and care-related strain, came directly from the individual whose feelings or perceptions were being represente

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: February 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Boston Health Care System, Jamaica Plain	Boston	Massachusetts
United States	VA Boston Healthcare System, Brockton Campus	Brockton	Massachusetts
United States	Michael E DeBakey VA Medical Center	Houston	Texas
United States	Oklahoma City, OK	Oklahoma City	Oklahoma
United States	VA Medical Center, Providence	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Alzheimer's Association, Benjamin Rose Institute

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bass DM, Judge KS, Snow AL, Wilson NL, Looman WJ, McCarthy C, Morgan R, Ablorh-Odjidja C, Kunik ME. Negative caregiving effects among caregivers of veterans with dementia. Am J Geriatr Psychiatry. 2012 Mar;20(3):239-47. doi: 10.1097/JGP.0b013e31824108ca. — View Citation

Bass DM, Judge KS, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy CA, Maslow K, Moye JA, Randazzo R, Garcia-Maldonado M, Elbein R, Odenheimer G, Kunik ME. Caregiver outcomes of partners in dementia care: effect of a care coordination program for vetera — View Citation

Bass DM, Judge KS, Snow AL, Wilson NL, Morgan RO, Maslow K, Randazzo R, Moye JA, Odenheimer GL, Archambault E, Elbein R, Pirraglia P, Teasdale TA, McCarthy CA, Looman WJ, Kunik ME. A controlled trial of Partners in Dementia Care: veteran outcomes after si — View Citation

Bejjani C, Snow AL, Judge KS, Bass DM, Morgan RO, Wilson N, Walder A, Looman WJ, McCarthy C, Kunik ME. Characteristics of Depressed Caregivers of Veterans With Dementia. Am J Alzheimers Dis Other Demen. 2015 Nov;30(7):672-8. doi: 10.1177/1533317512461555. — View Citation

Bradford A, Upchurch C, Bass D, Judge K, Snow AL, Wilson N, Kunik ME. Knowledge of documented dementia diagnosis and treatment in veterans and their caregivers. Am J Alzheimers Dis Other Demen. 2011 Mar;26(2):127-33. doi: 10.1177/1533317510394648. Epub 20 — View Citation

Judge KS, Bass DM, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy C, Kunik ME. Partners in dementia care: a care coordination intervention for individuals with dementia and their family caregivers. Gerontologist. 2011 Apr;51(2):261-72. doi: 10.1093/ger — View Citation

Shrestha S, Judge KS, Wilson NL, Moye JA, Snow AL, Kunik ME. Utilization of legal and financial services of partners in dementia care study. Am J Alzheimers Dis Other Demen. 2011 Mar;26(2):115-20. doi: 10.1177/1533317510394156. Epub 2011 Jan 13. — View Citation

Shub D, Bass DM, Morgan RO, Judge KS, Snow AL, Wilson NL, Walder A, Murry B, Kunik ME. Irritability and social isolation in dementia patients with and without depression. J Geriatr Psychiatry Neurol. 2011 Dec;24(4):229-34. doi: 10.1177/0891988711427039. — View Citation

Steiger-Gallagher K, Bass DM, Judge KS, Snow L, Wilson NL, Morgan RO, Walder A, Kunik ME. Satisfaction with dementia care. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2012 Apr 1; 29(4):33-40.

Weber SR, Pirraglia PA, Kunik ME. Use of services by community-dwelling patients with dementia: a systematic review. Am J Alzheimers Dis Other Demen. 2011 May;26(3):195-204. doi: 10.1177/1533317510392564. Epub 2011 Jan 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial well-being (patient and caregiver), health care service use (patient only), and health care cost (patient only)		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.	No
Secondary	Role and intra-psychic strain		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.	No