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OpenTrials
Completed

NCT Number: NCT05278650

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • Medication Therapy Management (MTM);
  • Medication co-payment assistance;
  • Tailored community referrals; and
  • Medicare insurance counseling

Primary outcomes

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

    Time frame: 13 months post-completion of learning collaborative

Secondary outcomes

  1. Percentage of Older Adults Receiving Medication Therapy Management

    Time frame: 13 months post-completion of learning collaborative

  2. Percentage of Older Adults Receiving Medication Co-pay Assistance

    Time frame: 13 months post-completion of learning collaborative

  3. Percentage of Older Adults Receiving at Least One Tailored Community Referral

    Time frame: 13 months post-completion of learning collaborative

  4. Percentage of Older Adults Receiving Medicare Counseling

    Time frame: 13 months post-completion of learning collaborative

Other outcomes

  1. Change in Self-rated Health

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2022
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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