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

Implementation Science Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05278650
• Other study ID #: Pro00110307
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implementation Science
• Medication Therapy Management

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-rated Health	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.	Baseline, 13 months post-completion of learning collaborative
Primary	Proportion of older adults seeking service who received all 4 components of Senior PharmAssist intervention		13 months post-completion of learning collaborative
Secondary	Proportion of older adults receiving Medication Therapy Management		13 months post-completion of learning collaborative
Secondary	Proportion of older adults receiving medication co-pay assistance		13 months post-completion of learning collaborative
Secondary	Proportion of older adults receiving at least one tailored community referral		13 months post-completion of learning collaborative
Secondary	Proportion of older adults receiving Medicare counseling		13 months post-completion of learning collaborative