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

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05278650
Collaborator
(none)
30
1
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Senior PharmAssist^TM Program Implementation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of older adults seeking service who received all 4 components of Senior PharmAssist intervention [6 months post-completion of learning collaborative]

Secondary Outcome Measures

  1. Proportion of older adults receiving Medication Therapy Management [6 months post-completion of learning collaborative]

  2. Proportion of older adults receiving medication co-pay assistance [6 months post-completion of learning collaborative]

  3. Proportion of older adults receiving at least one tailored community referral [6 months post-completion of learning collaborative]

  4. Proportion of older adults receiving Medicare counseling [6 months post-completion of learning collaborative]

Other Outcome Measures

  1. Change in Self-rated Health [Baseline, 6 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Eleanor McConnell, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05278650
Other Study ID Numbers:
  • Pro00110307
First Posted:
Mar 14, 2022
Last Update Posted:
Jul 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 15, 2022