Trial Outcomes & Findings for Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation (NCT NCT05278650)

NCT ID: NCT05278650

Last Updated: 2025-05-21

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

13 months post-completion of learning collaborative

Results posted on

2025-05-21

Participant Flow

Participant milestones

Participant milestones
Measure
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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling
Overall Study
STARTED
7
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Communities Adopting Senior PharmAssist Implementation Toolkit
n=7 Participants
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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling
Age, Continuous
81.7 years
STANDARD_DEVIATION 10.5 • n=99 Participants
Sex: Female, Male
Female
5 Participants
n=99 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=99 Participants
Race (NIH/OMB)
White
3 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
7 Participants
n=99 Participants

PRIMARY outcome

Timeframe: 13 months post-completion of learning collaborative

Outcome measures

Outcome measures
Measure
Communities Adopting Senior PharmAssist Implementation Toolkit
n=7 Participants
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: 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
0 Participants

SECONDARY outcome

Timeframe: 13 months post-completion of learning collaborative

Outcome measures

Outcome measures
Measure
Communities Adopting Senior PharmAssist Implementation Toolkit
n=7 Participants
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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling
Percentage of Older Adults Receiving Medication Therapy Management
100 percentage of participants

SECONDARY outcome

Timeframe: 13 months post-completion of learning collaborative

Outcome measures

Outcome measures
Measure
Communities Adopting Senior PharmAssist Implementation Toolkit
n=7 Participants
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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling
Percentage of Older Adults Receiving Medication Co-pay Assistance
28.57 percentage of participants

SECONDARY outcome

Timeframe: 13 months post-completion of learning collaborative

Outcome measures

Outcome measures
Measure
Communities Adopting Senior PharmAssist Implementation Toolkit
n=7 Participants
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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling
Percentage of Older Adults Receiving at Least One Tailored Community Referral
42.86 percentage of participants

SECONDARY outcome

Timeframe: 13 months post-completion of learning collaborative

Outcome measures

Outcome measures
Measure
Communities Adopting Senior PharmAssist Implementation Toolkit
n=7 Participants
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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling
Percentage of Older Adults Receiving Medicare Counseling
71.43 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 months post-completion of learning collaborative

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.

Outcome measures

Outcome data not reported

Adverse Events

Communities Adopting Senior PharmAssist Implementation Toolkit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eleanor McConnell, Ph.D.

Duke University

Phone: 919-684-9229

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place