NCT07018232

Brief Summary

Objective: Among patients discharged from the hospital with changes in maintenance prescription medication, how does experiencing a medication access gap compared to a no medication access gap impact the time to first unplanned healthcare encounter? This is a retrospective, cohort study conducted at two hospital sites in rural Pennsylvania and New York State using encounter data from the electronic health record to analyze any patient discharged with medication changes from June 1, 2023 to May 31, 2024.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 4, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

pharmacistmedication accesshospital discharge

Outcome Measures

Primary Outcomes (1)

  • Number of days to first unplanned healthcare encounter post-discharge

    The study will compare number of days between patients who had a medication gap and patients who had no medication gap

    90 days after discharge

Secondary Outcomes (2)

  • Number of days that a patient is without a prescribed medication post-discharge

    90 days after discharge

  • Describe the types of drug-related problems and/or medication access barriers between the two groups

    90 days after discharge

Study Arms (2)

Medication Gap

A patient with a medication gap was defined as 1) having lapse in prescription coverage or any number of days where they were out of a maintenance prescription medication because the primary care provider did not send in a refill in time, and 2) having a medication access barrier, such as needing to contact the primary care provider to send in a refill for a maintenance prescription medication.

Behavioral: Unplanned healthcare encounter

No Medication Gap

A patient with no medication gap was defined as having zero days without a maintenance prescription medication because it was appropriately refilled by their primary care provider at a transitions of care follow-up appointment

Behavioral: Unplanned healthcare encounter

Interventions

Patient needing to connect with healthcare to fill a medication gap

Medication GapNo Medication Gap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients discharged from an acute care hospital with a change in their chronic prescription medication regimen

You may qualify if:

  • Age 18 years and older
  • Have a Guthrie primary care provider
  • Discharged from the hospital to home or self-care (routine)
  • Had a medication change on discharge based on a discharge summary and/or after visit summary (AVS) containing "start taking these medications", "continue these medications which have changed", and/or "stop taking these previous medications".

You may not qualify if:

  • Age less than 18 years of age
  • Do not have a Guthrie primary care provider
  • Discharged from the hospital to anywhere besides home or self-care (routine) such as to rehabilitation, long-term care, left against medical advice, or transferred to another type of healthcare institution
  • prescriptions on discharge that lack e-prescribing class
  • prescriptions on discharge for day supplies less than 28 days
  • prescriptions on discharge for day supplies greater than 45 days
  • prescriptions on discharge with 1 or more refills provided
  • prescriptions on discharge for as needed medications
  • prescriptions on discharge for anti-infective agent
  • prescriptions on discharge for short-term steroids
  • prescriptions on discharge for nausea medication
  • prescriptions on discharge for bowel regimen medication
  • prescriptions on discharge for diabetic or medical supplies
  • prescriptions on discharge for topical medications
  • prescriptions on discharge for cough suppressants,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Study Officials

  • Alison Van Dyke, PharmD

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

November 27, 2024

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations