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This project aims to evaluate the scalability of an established, evidence-based, multi-component intervention, Senior PharmAssist^TM (SPA), designed to improve function and quality of life of older adults with limited incomes. The investigators propose to refine existing SPA replication materials such as community readiness assessments, educational tools to facilitate implementation of care processes, and data collection tools for quality improvement with input from community stakeholders interested in implementation of the SPA intervention. After gathering feedback from key stakeholders in 3 diverse communities in North Carolina, and refining tools accordingly, SPA staff will then provide technical assistance to support implementation in these communities, using the Institute for Healthcare Improvement learning collaborative approach, to facilitate community agency staff implementation of the SPA core components with racially diverse older adults with limited incomes using small scale tests of change with feedback.
The investigators will collect data from key stakeholders including older adults, community volunteers, and agency staff regarding facilitators and barriers to implementation of SPA, and obtain aggregate data regarding older adult participants served, including demographics, participant satisfaction, and self-rated health. Data will be analyzed using a multiple case study design that incorporates both qualitative data on barriers and facilitators, as well as aggregated data on older adults enrolled in community programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Communities Adopting Senior PharmAssist Implementation Toolkit | Other | Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit. The toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senior PharmAssist^TM Program Implementation | Other | Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community. Community champions will be trained to deliver a community-based program to deliver the core components of SPA:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention | 13 months post-completion of learning collaborative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Older Adults Receiving Medication Therapy Management | 13 months post-completion of learning collaborative | |
| Percentage of Older Adults Receiving Medication Co-pay Assistance | 13 months post-completion of learning collaborative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-rated Health | Change from baseline in proportion of participants who rate their health as good to excellent. Scale of rating ranges from 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent. | Baseline, 13 months post-completion of learning collaborative |
Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Eleanor McConnell, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Communities Adopting Senior PharmAssist Implementation Toolkit | Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit. The toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place. Senior PharmAssist^TM Program Implementation: Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community. Community champions will be trained to deliver a community-based program to deliver the core components of SPA:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Communities Adopting Senior PharmAssist Implementation Toolkit | Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit. The toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place. Senior PharmAssist^TM Program Implementation: Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community. Community champions will be trained to deliver a community-based program to deliver the core components of SPA:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention | Posted | Count of Participants | Participants | 13 months post-completion of learning collaborative |
|
13 months post-completion of learning collaborative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Communities Adopting Senior PharmAssist Implementation Toolkit | Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit. The toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place. Senior PharmAssist^TM Program Implementation: Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community. Community champions will be trained to deliver a community-based program to deliver the core components of SPA:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eleanor McConnell, Ph.D. | Duke University | 919-684-9229 | eleanor.mcconnell@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2022 | May 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2022 | Feb 22, 2024 | ICF_000.pdf |
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|
| Percentage of Older Adults Receiving at Least One Tailored Community Referral | 13 months post-completion of learning collaborative |
| Percentage of Older Adults Receiving Medicare Counseling | 13 months post-completion of learning collaborative |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Percentage of Older Adults Receiving Medication Therapy Management | Posted | Number | percentage of participants | 13 months post-completion of learning collaborative |
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| Secondary | Percentage of Older Adults Receiving Medication Co-pay Assistance | Posted | Number | percentage of participants | 13 months post-completion of learning collaborative |
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| Secondary | Percentage of Older Adults Receiving at Least One Tailored Community Referral | Posted | Number | percentage of participants | 13 months post-completion of learning collaborative |
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| Secondary | Percentage of Older Adults Receiving Medicare Counseling | Posted | Number | percentage of participants | 13 months post-completion of learning collaborative |
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| Other Pre-specified | Change in Self-rated Health | Change from baseline in proportion of participants who rate their health as good to excellent. Scale of rating ranges from 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent. | Not Posted | Baseline, 13 months post-completion of learning collaborative | Participants |
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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