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PDC: Partners in Dementia Care: A Telephone Care Consultation Intervention Provided to Veterans in Partnership With Local Alzheimer's Association Chapters

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00291161
Collaborator
Benjamin Rose Institute (Other), Alzheimer's Association (Other)
994
Enrollment
6
Locations
2
Arms
50
Duration (Months)
165.7
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

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 Alzheimer's 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). HI:PDC, compared to usual care, will improve psychosocial well-being for patients with dementia and their caregivers. H2:PDC, compared to usual care, will reduce health care service use for patients with dementia. H3:PDC is preferred to usual care based on 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. H5b:PDC, compared to usual care, will decrease caregiver role and intra-psychic strain. 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Partners in Dementia Care
 N/A

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 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).

  1. 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).

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 represented.

Study Design

Study Type:
Interventional
Actual Enrollment :
994 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Partners in Dementia Care
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Partners in Dementia Care

PDC is telephone-based care consultation intervention jointly delivered by care consultants in the VA and local Alzheimer's Association. The steps in care consultation included 1) Assessment of medical and non-medical care needs; 2) Development of a care plan that addresses needs of patients and caregivers; 3) on-going monitoring of the status, progress, and barriers encountered; and 4) Reassessment of care needs for patients and caregivers. PDC assisted families by: 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.

Behavioral: Partners in Dementia Care
Partners in Dementia Care 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.
No Intervention: Usual Care

Patients and caregivers at the three control VA settings were given a packet of educational materials on dementia and usual-care community resources.

Outcome Measures

Primary Outcome Measures

  1. Caregiver Outcomes [Baseline and at six months]

    The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)

  2. Veteran Outcomes [Baseline - six months]

    The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 VA Boston Health Care System, Jamaica Plain Boston Massachusetts United States 02130
2 VA Boston Healthcare System, Brockton Campus Brockton Massachusetts United States 02301
3 Oklahoma City, OK Oklahoma City Oklahoma United States 73104
4 VA Medical Center, Providence Providence Rhode Island United States 02908-4799
5 Beaumont VA Outpatient Clinic Beaumont Texas United States 77707
6 Michael E DeBakey VA Medical Center Houston Texas United States 77030

Sponsors and Collaborators

  • VA Office of Research and Development
  • Benjamin Rose Institute
  • Alzheimer's Association

Investigators

  • Principal Investigator: Mark E Kunik, MD MPH, Michael E. DeBakey VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00291161
Other Study ID Numbers:
  • IIR 04-238
First Posted:
Feb 13, 2006
Last Update Posted:
May 19, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by VA Office of Research and Development
Delivery of Health Care, Integrated
United States Department of Veterans Affairs
Dementia
Patient Care Management
Additional relevant MeSH terms:
Alzheimer Disease
Dementia

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Veterans: Partners in Dementia Care Intervention Veterans: Usual Care Comparison Caregivers: Partners in Dementia Care Intervention Caregivers: Usual Care Comparison
Arm/Group Description A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly. Patients and caregivers were provided usual care and an educational booklet on dementia Caregivers for Veterans assigned to the Partners in Dementia Care Intervention Caregivers of the Veterans assigned to the Usual Care Comparison
Period Title: Overall Study
STARTED 316 192 299 187
COMPLETED 235 134 206 122
NOT COMPLETED 81 58 93 65

Baseline Characteristics

Arm/Group Title Veterans-PDC Group Veterans-Usual Care Comparison Group Caregivers-PDC Group Caregivers-Usual Care Comparison Group Total
Arm/Group Description Veterans with diagnosed dementia receiving the PDC Intervention Veterans with diagnosed dementia receiving educational materials and usual care Caregivers to veterans with diagnosed dementia receiving the PDC Intervention Caregivers to veterans with diagnosed dementia receiving educational materials and usual care Total of all reporting groups
Overall Participants 316 192 299 187 994
Age (years) [Mean (Standard Deviation) ]
Age of Veterans
79.4
(8.2)
80.7
(6.2)
NA
(NA)
NA
(NA)
79.9
(7.6)
Age of Caregivers
NA
(NA)
NA
(NA)
68.0
(12.6)
70.8
(11.4)
69.1
(12.2)
Sex: Female, Male (Count of Participants)
Female
11
3.5%
3
1.6%
283
94.6%
178
95.2%
475
47.8%
Male
305
96.5%
189
98.4%
16
5.4%
9
4.8%
519
52.2%
Race/Ethnicity, Customized (participants) [Number]
White nonhispanic
234
74.1%
178
92.7%
222
74.2%
170
90.9%
804
80.9%
Black nonhispanic
64
20.3%
11
5.7%
56
18.7%
14
7.5%
145
14.6%
Hispanic
12
3.8%
0
0%
16
5.4%
0
0%
28
2.8%
Other
6
1.9%
3
1.6%
5
1.7%
3
1.6%
17
1.7%
Number of Caregivers Who were Spouses (participants) [Number]
Caregivers who were spouses
NA
NaN
NA
NaN
204
68.2%
149
79.7%
NA
NaN
Caregivers who were not spouses
NA
NaN
NA
NaN
95
31.8%
38
20.3%
NA
NaN

Outcome Measures

1. Primary Outcome
Title Caregiver Outcomes
Description The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)
Time Frame Baseline and at six months

Outcome Measure Data

Analysis Population Description
Data were collected for caregivers only
Arm/Group Title Caregivers: Partners in Dementia Care Intervention Caregivers: Usual Care Comparison
Arm/Group Description A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly. Patients and caregivers were provided usual care and an educational booklet on dementia
Measure Participants 299 187
Unmet need at Baseline
18.6
(11.8)
14.5
(11.2)
Unmet need at Six months
10.0
(9.9)
10.5
(10.0)
Role Captivity at baseline
3.7
(1.6)
3.5
(1.4)
Role Captivity at 6 months
3.6
(1.6)
3.2
(1.6)
Physical Health Strain at Baseline
3.7
(1.6)
3.6
(1.3)
Physical Health Strain at 6 months
3.5
(1.4)
3.6
(1.5)
Relationship Strain at Baseline
7.2
(2.5)
6.8
(2.1)
Relationship Strain at 6 months
7.0
(2.6)
6.3
(2.3)
Caregiver Support Service use at baseline
.4
(.7)
.4
(.7)
Caregiver support service at 6 months
.7
(.7)
.5
(.7)
Depression at baseline
4.5
(3.9)
4.0
(2.9)
Depression at 6 months
4.7
(3.9)
5.0
(4.1)
Number of informal helpers at baseline
4.3
(4.8)
4.3
(5.1)
Number of informal helpers at 6 month
4.7
(5.8)
4.8
(9.1)
2. Primary Outcome
Title Veteran Outcomes
Description The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).
Time Frame Baseline - six months

Outcome Measure Data

Analysis Population Description
Data were collected for veterans who could be interviewed only.
Arm/Group Title Partners in Dementia Care Intervention Usual Care Comparison
Arm/Group Description A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly. Patients and caregivers were provided usual care and an educational booklet on dementia
Measure Participants 152 103
Embarrassment about memory problems at baseline
1.02
(1.19)
.89
(1.08)
Embarrassment about memory problems at 6 months
.82
(1.09)
.91
(1.10)
Depression at baseline
2.68
(2.44)
2.19
(2.10)
Depression at 6 months
2.52
(2.59)
2.37
(2.34)
Unmet need at baseline
7.00
(6.93)
5.44
(6.00)
Unmet need at 6 months
5.05
(6.14)
4.40
(5.58)
Isolation at baseline
1.38
(1.49)
1.06
(1.30)
Isolation at 6 months
1.13
(1.39)
1.09
(1.37)
Relationship strain at baseline
.46
(1.04)
.38
(.87)
Relationship strain at 6 months
.49
(1.02)
.32
(.79)

Adverse Events

Time Frame
Adverse Event Reporting Description Adverse Events only assessed for Veterans
Arm/Group Title Veterans-PDC Group Veterans-Usual Care Comparison Group
Arm/Group Description Veterans with diagnosed dementia receiving the PDC Intervention Veterans with diagnosed dementia receiving educational materials and usual care
All Cause Mortality
Veterans-PDC Group Veterans-Usual Care Comparison Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Veterans-PDC Group Veterans-Usual Care Comparison Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/316 (0%) 0/192 (0%)
Other (Not Including Serious) Adverse Events
Veterans-PDC Group Veterans-Usual Care Comparison Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/316 (0%) 0/192 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Mark Kunik, MD, MPH
Organization Houston HSRD Center of Excellence
Phone 713-794-8639
Email kunik.marke@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00291161
Other Study ID Numbers:
  • IIR 04-238
First Posted:
Feb 13, 2006
Last Update Posted:
May 19, 2016
Last Verified:
May 1, 2016