Clinical trial NCT05278650: Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation
Official title: Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Therapy Management
Implementation Science
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 7
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention
timeFrame: 13 months post-completion of learning collaborative
Secondary outcomes:
measure: Percentage of Older Adults Receiving Medication Therapy Management
timeFrame: 13 months post-completion of learning collaborative
measure: Percentage of Older Adults Receiving Medication Co-pay Assistance
timeFrame: 13 months post-completion of learning collaborative
measure: Percentage of Older Adults Receiving at Least One Tailored Community Referral
timeFrame: 13 months post-completion of learning collaborative
measure: Percentage of Older Adults Receiving Medicare Counseling
timeFrame: 13 months post-completion of learning collaborative
Other outcomes:
measure: Change in Self-rated Health
timeFrame: Baseline, 13 months post-completion of learning collaborative
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Eleanor McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References: