Care TransitionNCT05241951
Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities
A study testing Structured hand-off, Medication reconciliation during transitional period and Transitional medication monitoring in people with Care Transition, run by University of Washington at 1 site in United States.
Trial summary
The Pharmacy Integrated Transitions (PIT) program, utilizes a crossover randomized control design to evaluate the impact of a clinical pharmacist in decreasing medication related problems during a patient's transition from hospital to skilled nursing facility (SNF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care Transition
- What is being tested?
- Structured hand-off, Medication reconciliation during transitional period and Transitional medication monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,052 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 31 Oct 2025
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age and older
- patients receiving inpatient care at University of Washington Mountlake, University of Washington Northwest, Harborview, and Valley Medical Center hospitals to one of 14 collaborating SNF's on a day when the PIT program pharmacist is conducting the intervention
Who cannot join
- Under 18 years of age
- patients with a discharge on hospice care
- patients discharged on days that the pharmacist is not conducting the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Health System
Seattle, Washington, 98105
About this study
Official title: Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities Using a Pharmacy Integrated Transitional Team
The Pharmacy Integrated Transitions (PIT) program, utilizes a crossover randomized control design to evaluate the impact of a clinical pharmacist in decreasing medication related problems during a patient's transition from hospital to skilled nursing facility (SNF).
Read the detailed description
Standard hospital discharge processes (e.g. as recommended by the Joint Commission Center for Transforming Healthcare), include hospital staff completing a paper-based discharge summary and medication reconciliation form. To reduce the likelihood of medication-related problems during care transitions, the Pharmacy Integrated Transitions (PIT) program aims to improve the standard transition process by adding a coordinating transitional pharmacist to provide a structured synchronous "warm-handoff" between clinical teams at the hospital and the Skilled Nursing Facility, in addition to reconciling, adjusting, and monitoring medications during and after discharge from the hospital.
- Conditions
- Care Transition
- Being tested
- Structured hand-off, Medication reconciliation during transitional period, Transitional medication monitoring, Teleconsultation
- Keywords
- Care Transition, Medication-Related Problems, Post-Acute Care, Skilled Nursing Facility, Hospital Systems, Medication Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured hand-offOther
Also called Standardized Checklist
Use of standardized checklist to provide synchronous or asynchronous handoff that conveys medication recommendations to the SNF clinical teams
Medication reconciliation during transitional periodOther
Comprehensive medication reconciliation conducted during transitional period between hospital and SNF, focused on SNF-specific requirements for medication delivery (e.g., stop dates, titration instructions)
Transitional medication monitoringOther
Review of medication orders during first 7 days of SNF admittance to address barriers to translation of medication orders and appropriate medication delivery
TeleconsultationOther
Ad hoc consultation to provide additional clarification to SNF clinical teams
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pharmacist in Transition of Care | Experimental | A clinical pharmacist will be provided as a patient discharges from one of four University of Washington (UW) medical centers to one of 14 post acute skilled nursing facilities randomized to the intervention arm. The coordinating transitional pharmacist will conduct (1) a comprehensive medication review including medication reconciliation, adjustment, and monitoring during the transitional period from hospital to SNF, 2) a structured handoff between clinical teams at the hospital and SNF. Receives: Other: Structured hand-off; Other: Medication reconciliation during transitional period; Other: Transitional medication monitoring; Other: Teleconsultation |
| Patient transitions from hospital to post-acute care | No intervention | Patient will transition from one of four University of Washington (UW) medical centers to one of 14 post-acute skilled nursing facilities randomized to the control arm. Patients will receive the standard discharge process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Related Problems
Number of medication related problems experienced by patients within 30 days post hospital discharge.
Measured: 30 days post hospital discharge
Secondary outcomes (2)
Death
Number of deaths experienced by patients within each cohort
Measured: 30 Days post hospital discharge
Readmissions
Number of readmissions within 30 days of index hospital discharge
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start31 Jan 2022
- Primary completion1 Mar 2024
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Care TransitionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A parallel cluster-randomized controlled crossover trial design, with randomization occurring at the skilled nursing facility cluster level. The trial is conducted across four hospitals and 14 independent SNFs in Washington State. SNF's are stratified by patient volume before randomly assigned to either the PIT program or usual care.
- Masking
- None (open label)
- Enrolment
- 1,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Giana Davidson, University of Washington
- Investigators
- Giana Davidson, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241951
- Sponsor's protocol ID
- STUDY00011018
- Other IDs
- 1R01HS027805
- Status last verified
- Nov 2025
- First submitted
- 28 Jan 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
Hantouli MN, Monsell SE, Davidson GH, Chaing J, Comstock B, Dervish AA, Gionet NJ, Howard S, Jimenez N, Kim C, Liberman M, Lindo EG, Marcum ZA, Ong TD, Serrano E, Simons K, Sun LS, Zaslavsky O, Austin E; PIT Collaborative. Pharmacy Integrated Transitions (PIT) trial: a protocol for a pragmatic cluster-randomised crossover trial. BMJ Open. 2024 Dec 31;14(12):e088786. doi: 10.1136/bmjopen-2024-088786.
PubMed 39740951
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities Using a Pharmacy Integrated Transitional Team
- ClinicalTrials.gov ID
- NCT05241951
- Acronym / sponsor ID
- STUDY00011018
- Conditions
- Care Transition
- Keywords
- Care Transition, Medication-Related Problems, Post-Acute Care, Skilled Nursing Facility, Hospital Systems, Medication Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,052 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 16 Feb 2022 (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.
The Pharmacy Integrated Transitions (PIT) program, utilizes a crossover randomized control design to evaluate the impact of a clinical pharmacist in decreasing medication related problems during a patient's transition from hospital to skilled nursing facility (SNF).
Detailed description
Standard hospital discharge processes (e.g. as recommended by the Joint Commission Center for Transforming Healthcare), include hospital staff completing a paper-based discharge summary and medication reconciliation form. To reduce the likelihood of medication-related problems during care transitions, the Pharmacy Integrated Transitions (PIT) program aims to improve the standard transition process by adding a coordinating transitional pharmacist to provide a structured synchronous "warm-handoff" between clinical teams at the hospital and the Skilled Nursing Facility, in addition to reconciling, adjusting, and monitoring medications during and after discharge from the hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel cluster-randomized controlled crossover trial design, with randomization occurring at the skilled nursing facility cluster level. The trial is conducted across four hospitals and 14 independent SNFs in Washington State. SNF's are stratified by patient volume before randomly assigned to either the PIT program or usual care.
| Arm | Type | Receives |
|---|---|---|
| Clinical Pharmacist in Transition of Care | Experimental | Other: Structured hand-off, Other: Medication reconciliation during transitional period, Other: Transitional medication monitoring, Other: TeleconsultationA clinical pharmacist will be provided as a patient discharges from one of four University of Washington (UW) medical centers to one of 14 post acute skilled nursing facilities randomized to the intervention arm. The coordinating transitional pharmacist will conduct (1) a comprehensive medication review including medication reconciliation, adjustment, and monitoring during the transitional period from hospital to SNF, 2) a structured handoff between clinical teams at the hospital and SNF. |
| Patient transitions from hospital to post-acute care | No intervention | –Patient will transition from one of four University of Washington (UW) medical centers to one of 14 post-acute skilled nursing facilities randomized to the control arm. Patients will receive the standard discharge process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and older
- patients receiving inpatient care at University of Washington Mountlake, University of Washington Northwest, Harborview, and Valley Medical Center hospitals to one of 14 collaborating SNF's on a day when the PIT program pharmacist is conducting the intervention
Key exclusion criteria (3 listed)
- Under 18 years of age
- patients with a discharge on hospice care
- patients discharged on days that the pharmacist is not conducting the intervention
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 |
|---|---|---|
| Structured hand-offAlso: Standardized ChecklistUse of standardized checklist to provide synchronous or asynchronous handoff that conveys medication recommendations to the SNF clinical teams | Other | Clinical Pharmacist in Transition of Care |
| Medication reconciliation during transitional periodComprehensive medication reconciliation conducted during transitional period between hospital and SNF, focused on SNF-specific requirements for medication delivery (e.g., stop dates, titration instructions) | Other | Clinical Pharmacist in Transition of Care |
| Transitional medication monitoringReview of medication orders during first 7 days of SNF admittance to address barriers to translation of medication orders and appropriate medication delivery | Other | Clinical Pharmacist in Transition of Care |
| TeleconsultationAd hoc consultation to provide additional clarification to SNF clinical teams | Other | Clinical Pharmacist in Transition of Care |
Primary outcome
Medication Related Problems
Time frame: 30 days post hospital discharge
Number of medication related problems experienced by patients within 30 days post hospital discharge.
2 secondary outcomes
Death
Time frame: 30 Days post hospital discharge
Readmissions
Time frame: 30 Days
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 24 Nov 2025.
- Derived from this study: PubMed 39740951Hantouli MN, Monsell SE, Davidson GH, Chaing J, Comstock B, Dervish AA, Gionet NJ, Howard S, Jimenez N, Kim C, Liberman M, Lindo EG, Marcum ZA, Ong TD, Serrano E, Simons K, Sun LS, Zaslavsky O, Austin E; PIT Collaborative. Pharmacy Integrated Transitions (PIT) trial: a protocol for a pragmatic cluster-randomised crossover trial. BMJ Open. 2024 Dec 31;14(12):e088786. doi: 10.1136/bmjopen-2024-088786.
- Focused on evaluating the effectiveness and value of healthcare and keeping the patient's voice central, CERTAIN is a revolutionary approach to improving quality through actionable research.Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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.
Giana Davidson, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured hand-off, Medication reconciliation during transitional period and Transitional medication monitoring in people with Care Transition, run by University of Washington 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 2 inclusion and 3 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 24 Nov 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?
Medication Related Problems (time frame: 30 days post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241951, which also lists 1 linked publication.
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 24 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.