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

February 22, 2024 updated by: Duke University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of older adults seeking service who received all 4 components of Senior PharmAssist intervention
Time Frame: 13 months post-completion of learning collaborative
13 months post-completion of learning collaborative

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of older adults receiving Medication Therapy Management
Time Frame: 13 months post-completion of learning collaborative
13 months post-completion of learning collaborative
Proportion of older adults receiving medication co-pay assistance
Time Frame: 13 months post-completion of learning collaborative
13 months post-completion of learning collaborative
Proportion of older adults receiving at least one tailored community referral
Time Frame: 13 months post-completion of learning collaborative
13 months post-completion of learning collaborative
Proportion of older adults receiving Medicare counseling
Time Frame: 13 months post-completion of learning collaborative
13 months post-completion of learning collaborative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 13 months post-completion of learning collaborative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Eleanor McConnell, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00110307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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