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

NCT05278650 | Completed Results

• 1 other identifier: Pro00110307
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Therapy Management; Implementation Science

Outcome Measures

Primary Outcomes (1)

• Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention

  13 months post-completion of learning collaborative

Secondary Outcomes (4)

• 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 Outcomes (1)

• Change in Self-rated Health

  Baseline, 13 months post-completion of learning collaborative

Study Arms (1)

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.

Other: Senior PharmAssist^TM Program Implementation

Interventions

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: 1. Medication Therapy Management (MTM); 2. Medication co-payment assistance; 3. Tailored community referrals; and 4. Medicare insurance counseling

Communities Adopting Senior PharmAssist Implementation Toolkit

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Eleanor McConnell, Ph.D.
• Organization: Duke University

eleanor.mcconnell@duke.edu

919-684-9229

Study Officials

• Eleanor McConnell, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: August 24, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)