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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05278650

Enrollment

Registered

2022-03-14

Start date

2022-08-24

Completion date

2024-07-31

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implementation Science, Medication Therapy Management

Brief 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. 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.

Interventions

OTHERSenior 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame
Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention	13 months post-completion of learning collaborative

Secondary

Measure	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
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

Other

Measure	Time frame	Description
Change in Self-rated Health	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	7
Total	7

Arm

Count

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

Total

Baseline characteristics

Characteristic	Communities Adopting Senior PharmAssist Implementation Toolkit
Age, Continuous	81.7 years STANDARD_DEVIATION 10.5
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	3 Participants
Region of Enrollment United States	7 Participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 7
other Total, other adverse events	0 / 7
serious Total, serious adverse events	0 / 7