Transitional CareNCT07018232
Enhancing Timely Access to Medication Changes: The Role of Pharmacists in Overcoming Transitions of Care Challenges
An observational study of Transitional Care, run by The Guthrie Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Care
- What is being tested?
- Unplanned healthcare encounter
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2024to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients discharged from an acute care hospital with a change in their chronic prescription medication regimen
Who may be able to join
- 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".
Who cannot join
- 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
Show all 17Show fewer
- 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,
- prescriptions on discharge for vitamins and supplements
- prescriptions on discharge for medications that can be purchased over the counter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Timely Access to Medication Changes: The Role of Ambulatory Care Pharmacists in Overcoming Transitions of Care Challenges
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.
Read the detailed description
Background: Transitions of care are high-risk periods marked by frequent medication-related problems with up to 80% of discharged patients and 98% of older adults experiencing discrepancies in their medication regimens. These gaps, often due to delayed prescription refills or poor care coordination, contribute to unplanned healthcare encounters, increased costs, and strain on providers. Pharmacists can mitigate these risks by improving medication access and continuity.
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.
- Conditions
- Transitional Care
- Being tested
- Unplanned healthcare encounter
- Keywords
- pharmacist, medication access, hospital discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unplanned healthcare encounterBehavioural
Patient needing to connect with healthcare to fill a medication gap
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Unplanned healthcare encounter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days after discharge
Secondary outcomes (2)
Number of days that a patient is without a prescribed medication post-discharge
The study will compare the number of days patients are without a prescribed medication after hospital discharge, for the two groups (1 patients who had a medication gap and 2 patients who had no medication gap).
Measured: 90 days after discharge
Describe the types of drug-related problems and/or medication access barriers between the two groups
The study will compare the types of drug-related problems and medication access barriers between the two groups (1 patients who had a medication gap and 2 patients who had no medication gap).
Measured: 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start27 Nov 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Van Dyke, PharmD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018232
- Sponsor's protocol ID
- 2411-102
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Timely Access to Medication Changes: The Role of Ambulatory Care Pharmacists in Overcoming Transitions of Care Challenges
- ClinicalTrials.gov ID
- NCT07018232
- Acronym / sponsor ID
- 2411-102
- Conditions
- Transitional Care
- Keywords
- pharmacist, medication access, hospital discharge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Transitions of care are high-risk periods marked by frequent medication-related problems with up to 80% of discharged patients and 98% of older adults experiencing discrepancies in their medication regimens. These gaps, often due to delayed prescription refills or poor care coordination, contribute to unplanned healthcare encounters, increased costs, and strain on providers. Pharmacists can mitigate these risks by improving medication access and continuity.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Gap | – | Behavioral: Unplanned healthcare encounterA 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. |
| No Medication Gap | – | Behavioral: Unplanned healthcare encounterA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients discharged from an acute care hospital with a change in their chronic prescription medication regimen
Key inclusion criteria (4 listed)
- 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".
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unplanned healthcare encounterPatient needing to connect with healthcare to fill a medication gap | Behavioural | Medication Gap, No Medication Gap |
Primary outcome
Number of days to first unplanned healthcare encounter post-discharge
Time frame: 90 days after discharge
The study will compare number of days between patients who had a medication gap and patients who had no medication gap
2 secondary outcomes
Number of days that a patient is without a prescribed medication post-discharge
Time frame: 90 days after discharge
Describe the types of drug-related problems and/or medication access barriers between the two groups
Time frame: 90 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Van Dyke, PharmD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transitional Care, run by The Guthrie Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days to first unplanned healthcare encounter post-discharge (time frame: 90 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.