- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06581224
Implementation of a Primary Hospital Provider (PHP) Team (PHP Team)
Implementation of a Primary Hospitalist Provider Team to Enhance the Care for High-Need High-Complexity Patients Requiring Hospitalization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of this study is to reduce inpatient care fragmentation for high-need, high-complexity (HNHC) patients and improve outcomes by implementing a primary hospital provider (PHP) team. In this study, we will specifically evaluate the feasibility of implementation of this team as well as workforce and operational acceptance, as well as its impact on continuity of hospital medicine care across subsequent admissions.
The study is conducted as a two-arm, pragmatic hybrid type II effectiveness implementation trial with two sequential phases. Phase 1 focuses on initial feasibility and early acceptability of the PHP team. Phase 2 evaluates sustained implementation, reach, and longitudinal continuity outcomes using the same intervention, eligibility criteria, and study procedures. No changes will be made to the intervention, eligibility criteria, or data collection methods between phases.
Study Aims:
Aim 1 Primary Implementation Objective: Compare the fragmentation in hospital medicine care during subsequent admissions for HNHC patients assigned to the PHP team with those continuing to receive usual care.
- Aim 1a (Phase 1): Assess feasibility and early continuity of care during subsequent admissions.
- Aim 1b (Phase 2): Evaluate sustained continuity and re-exposure to the PHP team across repeated hospitalizations over an extended enrollment period.
Aim 2 Primary Exploratory Objective: Explore perceptions of care among HNHC patients and caregivers randomized to the PHP team and to a usual care team.
Aim 3 Secondary Exploratory Objective: Identify operational perceptions of the implementation of the PHP team from a workforce and system-level perspective.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Westergaard, MD, MPH
- Phone Number: 608-261-1150
- Email: swesterga@medicine.wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- UW Hospital and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age greater than 18 at the time of index admission
- Two or more hospitalizations to a general medicine service at UW Health (University Hospital or East Madison Hospital) within the past 12 months AND an EPIC Readmission Risk Score of greater than a predetermined value
Exclusion Criteria:
- Outpatient primary care provider is part of the UW Health Family Medicine service that currently admits their own patients to a separate service at University Hospital
- Patients with an oncologic diagnosis for which they are actively receiving chemotherapy or immunotherapy
- Incarcerated persons
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PHP Team
|
The PHP team aims to enhance continuity during hospital readmissions with a consistent cohort of seven hospital medicine physicians and two advanced practice providers (APPs).
To improve care transitions, the team will have an integrated case manager who will continue following PHP patients during subsequent hospitalizations.
Physicians will follow a standard seven-day service schedule, with the two APPs alternating five-to-seven-day periods.
Daily huddles between physicians and APPs will further promote continuity.
During the index admission, the PHP team will create a care plan in consultation with the patient to improve standardization of inpatient care and transition to outpatient settings.
Communication will be a core tenet of the team, with scheduled monthly team meetings of physicians, APPs, case manager, dyad partner, and representatives from nursing and therapy services to revise individualized care plans for PHP patients and brainstorm solutions for complex challenges.
|
|
No Intervention: Usual Care
Usual Care hospital medicine team
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients readmitted to the PHP team
Time Frame: Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
The number of patients in the PHP arm who were readmitted to the PHP team on subsequent hospitalizations.
|
Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
|
Number of patients readmitted to usual care team
Time Frame: Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
The number of patients in the usual care arm who were readmitted to a usual care team on subsequent hospitalizations.
|
Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
|
Percentage of patients readmitted to the PHP team
Time Frame: Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
The percentage of patients in the PHP arm who were readmitted to the PHP team on subsequent hospitalizations.
|
Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
|
Percentage of patients readmitted to usual care team
Time Frame: Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
The percentage of patients in the usual care arm who were readmitted to a usual care team on subsequent hospitalizations.
|
Implementation Phase 1 up to 9 months, Sustained Implementation Phase 2 up to 33 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Themes that emerge as barriers from the hospitalist perspective
Time Frame: 4 months
|
Qualitative barriers during hospitalization for high-need, high-complexity patients that emerge from focus groups with hospitalists.
Focus groups will be coded and themed and reported here.
|
4 months
|
|
Themes that emerge as facilitators from the hospitalist perspective
Time Frame: 4 months
|
Qualitative facilitators during hospitalization for high-need, high-complexity patients that emerge from focus groups with hospitalists.
Focus groups will be coded and themed and reported here.
|
4 months
|
|
Acceptability as assessed from the hospitalist perspective
Time Frame: 6 months
|
Acceptability of the intervention will be assessed from focus groups with hospitalists.
Hospitalists will be coded and themed and reported here
|
6 months
|
|
Themes that emerge as barriers from the patient and/or caregiver perspective
Time Frame: 6 months
|
Qualitative barriers during hospitalization for high-need, high-complexity patients that emerge from patient and/or caregiver interviews.
Interviews will be coded and themed and reported here.
|
6 months
|
|
Themes that emerge as facilitators from the patient and/or caregiver perspective
Time Frame: 6 months
|
Qualitative facilitators during hospitalization for high-need, high-complexity patients that emerge from patient and/or caregiver interviews.
Interviews will be coded and themed and reported here.
|
6 months
|
|
Acceptability as assessed from the patient and/or caregiver perspective
Time Frame: 6 months
|
Acceptability of the intervention will be assessed from patient and/or caregiver interviews.
Interviews will be coded and themed and reported here
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Westergaard, MD, MPH, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-1299
- A534270 (Other Identifier: UW Madison)
- Protocol Version 12/23/25 (Other Identifier: DCP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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