Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291161
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2006-02-10
Brief Title:
Partners in Dementia Care A Telephone Care Consultation Intervention Provided to Veterans in Partnership With Local Alzheimers Association Chapters
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Partners in Dementia Care
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDC
Brief 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 Alzheimers Association Chapters PDC 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 was to test the impact of PDC on outcomes for veterans with dementia and family caregivers Two specific research objectives and corresponding hypotheses were 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 HIPDC compared to usual care will improve psychosocial well-being for patients with dementia and their caregivers H2PDC compared to usual care will reduce health care service use for patients with dementia H3PDC is preferred to usual care based on cost-benefit analyses H4The 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 eg 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 H5aPDC compared to usual care will decrease patient role and intra-psychic strain H5bPDC compared to usual care will decrease caregiver role and intra-psychic strain H6The PDC intervention will be more effective in decreasing role and intra-psychic strains for patients and caregivers dealing with more severe patient impairment eg cognitive status functional status and level of problem behaviors
Objectives The primary objective was to test the impact of PDC on outcomes for veterans with dementia and family caregivers Two specific research objectives and corresponding hypotheses were 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 HIPDC compared to usual care will improve psychosocial well-being for patients with dementia and their caregivers H2PDC compared to usual care will reduce health care service use for patients with dementia H3PDC is preferred to usual care based on cost-benefit analyses H4The 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 eg 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 H5aPDC compared to usual care will decrease patient role and intra-psychic strain H5bPDC compared to usual care will decrease caregiver role and intra-psychic strain H6The PDC intervention will be more effective in decreasing role and intra-psychic strains for patients and caregivers dealing with more severe patient impairment eg cognitive status functional status and level of problem behaviors
Detailed 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 Alzheimers Managed Care Demonstration Bass Clark Looman McCarthy Eckert 2003 and the Chronic Care Networks for Alzheimers Disease CCNAD 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 Alzheimers Association AA chapters Essential features of PDC included 1 formal partnerships between VA medical centers and Alzheimers 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 eg 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 eg cognitive status functional status and level of problem behaviors
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 Alzheimers 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 Alzheimers Association Care Consultant AA CC in Alzheimers 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 eg 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 ie 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 represented
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 Alzheimers Managed Care Demonstration Bass Clark Looman McCarthy Eckert 2003 and the Chronic Care Networks for Alzheimers Disease CCNAD 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 Alzheimers Association AA chapters Essential features of PDC included 1 formal partnerships between VA medical centers and Alzheimers 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 eg 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 eg cognitive status functional status and level of problem behaviors
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 Alzheimers 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 Alzheimers Association Care Consultant AA CC in Alzheimers 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 eg 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 ie 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 represented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None