An interventional study of Senior PharmAssist^TM Program Implementation in Medication Therapy Management and Implementation Science, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Duke University · Not applicable, Interventional, and Health services research
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
None
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.
Other: 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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling
Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention
Time frame: 13 months post-completion of learning collaborative
Percentage of Older Adults Receiving Medication Therapy Management
Time frame: 13 months post-completion of learning collaborative
Percentage of Older Adults Receiving Medication Co-pay Assistance
Time frame: 13 months post-completion of learning collaborative
Percentage of Older Adults Receiving at Least One Tailored Community Referral
Time frame: 13 months post-completion of learning collaborative
Percentage of Older Adults Receiving Medicare Counseling
Time frame: 13 months post-completion of learning collaborative
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.
Time frame: Baseline, 13 months post-completion of learning collaborative
| Milestone | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
| Participants | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention | 0 |
| percentage of participants | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Percentage of Older Adults Receiving Medication Therapy Management | 100 |
| percentage of participants | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Percentage of Older Adults Receiving Medication Co-pay Assistance | 28.57 |
| percentage of participants | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Percentage of Older Adults Receiving at Least One Tailored Community Referral | 42.86 |
| percentage of participants | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Percentage of Older Adults Receiving Medicare Counseling | 71.43 |
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.
Results for this outcome have not been posted.
Collected over 13 months post-completion of learning collaborative. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Communities Adopting Senior PharmAssist Implementation Toolkit | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Mean | 81.7 ± 10.5 |
| Sex: Female, Male(Participants) | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Female | 5 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Communities Adopting Senior PharmAssist Implementation Toolkit |
|---|---|
| United States | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Duke University