Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities

NCT ID: NCT05241951

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1052 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2025-10-31

Brief Summary

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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

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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

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Care Transition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Clinical Pharmacist in Transition of Care

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.

Group Type EXPERIMENTAL

Structured hand-off

Intervention Type OTHER

Use of standardized checklist to provide synchronous or asynchronous handoff that conveys medication recommendations to the SNF clinical teams

Medication reconciliation during transitional period

Intervention Type OTHER

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 monitoring

Intervention Type OTHER

Review of medication orders during first 7 days of SNF admittance to address barriers to translation of medication orders and appropriate medication delivery

Teleconsultation

Intervention Type OTHER

Ad hoc consultation to provide additional clarification to SNF clinical teams

Patient transitions from hospital to post-acute care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Structured hand-off

Use of standardized checklist to provide synchronous or asynchronous handoff that conveys medication recommendations to the SNF clinical teams

Intervention Type OTHER

Medication reconciliation during transitional period

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)

Intervention Type OTHER

Transitional medication monitoring

Review of medication orders during first 7 days of SNF admittance to address barriers to translation of medication orders and appropriate medication delivery

Intervention Type OTHER

Teleconsultation

Ad hoc consultation to provide additional clarification to SNF clinical teams

Intervention Type OTHER

Other Intervention Names

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Standardized Checklist

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Under 18 years of age
* patients with a discharge on hospice care
* patients discharged on days that the pharmacist is not conducting the intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Giana Davidson

Associate Professor, School of Medicine: Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giana Davidson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington Health System

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39740951 (View on PubMed)

Related Links

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http://www.becertain.org/

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.

Other Identifiers

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1R01HS027805

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

STUDY00011018

Identifier Type: -

Identifier Source: org_study_id

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