Medication Therapy ManagementNCT05278650
Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation
A study testing Senior PharmAssist^TM Program Implementation in people with Medication Therapy Management and Implementation Science, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Medication Therapy Management, Implementation Science
- What is being tested?
- Senior PharmAssist^TM Program Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 or older
- Currently or soon to be enrolled in Medicare
- Income is at or below 200% of Poverty Line
- Lives in one of 3 targeted communities learning to implement the Senior PharmAssist^TM core services
- Seeks assistance with medications, Medicare counseling, or tailored referrals from agencies participating in Senior PharmAssist^TM learning collaborative
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
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.
- Being tested
- Senior PharmAssist^TM Program Implementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior PharmAssist^TM Program ImplementationOther
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:
- Medication Therapy Management (MTM);
- Medication co-payment assistance;
- Tailored community referrals; and
- Medicare insurance counseling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Senior PharmAssist^TM Program Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention
Measured: 13 months post-completion of learning collaborative
Secondary outcomes (4)
Percentage of Older Adults Receiving Medication Therapy Management
Measured: 13 months post-completion of learning collaborative
Percentage of Older Adults Receiving Medication Co-pay Assistance
Measured: 13 months post-completion of learning collaborative
Percentage of Older Adults Receiving at Least One Tailored Community Referral
Measured: 13 months post-completion of learning collaborative
Percentage of Older Adults Receiving Medicare Counseling
Measured: 13 months post-completion of learning collaborative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start24 Aug 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication Therapy ManagementStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor McConnell, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278650
- Sponsor's protocol ID
- Pro00110307
- Status last verified
- May 2025
- First submitted
- 4 Mar 2022
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation
- ClinicalTrials.gov ID
- NCT05278650
- Acronym / sponsor ID
- Pro00110307
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Communities Adopting Senior PharmAssist Implementation Toolkit | Other | Other: Senior PharmAssist^TM Program ImplementationThree 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60 or older
- Currently or soon to be enrolled in Medicare
- Income is at or below 200% of Poverty Line
- Lives in one of 3 targeted communities learning to implement the Senior PharmAssist^TM core services
- Seeks assistance with medications, Medicare counseling, or tailored referrals from agencies participating in Senior PharmAssist^TM learning collaborative
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senior PharmAssist^TM Program ImplementationRepresentatives 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 | Other | Communities Adopting Senior PharmAssist Implementation Toolkit |
Primary outcome
Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention
Time frame: 13 months post-completion of learning collaborative
4 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor McConnell, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senior PharmAssist^TM Program Implementation in people with Medication Therapy Management and Implementation Science, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention (time frame: 13 months post-completion of learning collaborative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.