Impact of a novel post-discharge clinic on post-hospital follow-up among Veterans
| ISRCTN | ISRCTN86866399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86866399 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PCIL-DC-Clinic |
| Sponsor | VA Puget Sound Health Care System |
| Funder | VA Health Services Research Services |
- Submission date
- 19/05/2025
- Registration date
- 23/05/2025
- Last edited
- 10/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This is a prospective, cluster-randomized quality improvement trial to evaluate the difference in time to access outpatient follow-up care in Veterans with a hospital discharge in the VA Puget Sound.
Our primary outcome of interest will be days between nurse index phone call to recently discharged patient and outpatient post-discharge clinic visit with a clinician in primary care (general medicine service line, MD, DO, PA, or NP). Secondary outcomes of interest will include 30-day post-discharge readmission rate and ER visits within 30 days of nurse index phone call. Exploratory outcomes will be primary care utilization, combined ER/UC use, prescription medication outcomes (total, discontinued, and safety events), and discharge summary availability.
Who can participate?
Primary care teams who are assigned to the intervention arm.
Patients who are assigned to a participating clinician team and engaged in primary care at the Veterans Health Administration in the Seattle clinic and have had a hospital discharge.
What does the study involve?
Current standard of practice is that primary care team nurses make phone outreach to empaneled patients recently discharged within 2 business days of nurse receipt of notification of hospital discharge. Notification to nursing staff is provided by centralized reporting (VSSC), with triggering by patient-self report during or after a non-VA hospitalization. Nurses can then opt to further arrange provider follow-up in clinic by any modality, based on triage of patient needs and complexity.
Among sites randomized to the active arm, participating cluster/pod nurses will have the option to schedule Veterans with a recent hospitalization to a follow-up, dedicated multidisciplinary discharge clinic occurring twice weekly. Usual care arm-cluster/pod nurses will have the option to schedule Veterans recently discharged to existing primary care grid openings, which can include the continuity provider or non-continuity provider (acute, resident trainee grid openings).
What are the possible benefits and risks of participating?
Participating clusters/pods of nursing will be randomly allocated to the active or usual-care arms affecting the administration of post discharge follow-up. Patients will not experience a difference in clinical care workflows or usual practices.
Where is the study run from?
VA Puget Sound Health Care System (USA)
When is the study starting and how long is it expected to run for?
May 2025 to June 2026
Who is funding the study?
This work will be supported by the Primary Care Analytics Team, funded by the VHA Office of Primary Care (USA)
Who is the main contact?
Brinn Jones (Project Manager), brinn.jones@va.gov
Contact information
Scientific, Principal investigator
1660 S Columbian Way
Seattle
98108
United States of America
| Phone | +1 206-277-6126 |
|---|---|
| Linnaea.Schuttner@va.gov |
Public
1660 S Columbian Way
Seattle
98108
United States of America
| Phone | +1 206-001-7125 |
|---|---|
| brinn.jones@va.gov |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center prospective cluster-randomized quality improvement trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Impact of a novel post-discharge clinic on post-hospital follow-up among Veterans |
| Study objectives | Veterans in the intervention arm (via site-level RN team empanelment) will have different number of days to scheduled outpatient primary care follow-up appointment than Veterans in the usual care arm, among those Veterans recently discharged from hospital stay. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This work was designated as non-research, quality improvement after review by the VHA Office of Primary Care under the national VHA Office of Research and Development policy of the U.S. Department of Veterans Affairs (VHA Office of Research & Development Program Guide 1200.21, “VHA Operations Activities That May Constitute Research,” issued Jan 9, 2019), consistent with the intent to resolve questions of operationally-relevant process optimization for the health system. This exempts the work from further VHA Institutional Review Board (IRB) review or exemption. Work under this designation is conducted following all methodologic, policy, and ethical guidelines and regulations governing the conduct of VHA Office of Primary Care non-research quality improvement activities. |
| Health condition(s) or problem(s) studied | Veterans with a hospital discharge in the VA Puget Sound |
| Intervention | This is a prospective, cluster-randomized quality improvement trial to evaluate the difference in time to access outpatient follow-up care in Veterans with a hospital discharge in the VA Puget Sound. The unit of randomization will be site of affiliate nurses. Sites (i.e., pods or clusters of nurses who share protocols for care within larger sites) in the VA Puget Sound will be identified by site leadership, if participating in a primary care teamlet (Patient Aligned Care Team, PACT) serving empaneled patients within affiliated VA primary care clinics. Among sites randomized to the active arm, team nurses will have the option to schedule Veterans with a recent hospitalization to a follow-up, dedicated multidisciplinary discharge clinic occurring twice weekly. Usual care arm-site team nurses will have the option to schedule Veterans recently discharged to existing primary care grid openings, which can include the continuity provider or non-continuity provider. 1. Active arm: Dedicated discharge clinic Intervention Type: Other Intervention Description: Dedicated, post-hospital multidisciplinary discharge clinic. 2. Control arm: Usual care Intervention Type: As-available scheduling into continuity provider clinic, or utilization of non-usual provider grid options, as permitted by openings. The intervention will last 6 months, and follow up for 7 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Days between nurse index phone call to recently discharged patient and outpatient post-discharge clinic visit with a clinician in primary care measured using patient records at end of study |
| Key secondary outcome measure(s) |
Secondary outcome measures: |
| Completion date | 15/06/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient, Employee |
|---|---|
| Age group | All |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Key inclusion criteria | Clusters/pods of nursing staff will be eligible of there is: 1. >1 active RN care manager per pod serving assigned patients, 2. Pod is located at a clinic within VA Puget Sound 3. RN within a pod is assigned to patient aligned care team (PACT) with primary care providers delivering outpatient continuity care to patients Patients are eligible: 1. Assigned to a PACT within an eligible pod RN 2. Receiving empaneled primary care from an clinic in the VA Puget Sound 3. Have at least 1 outpatient visit in the past 24 months 4. Have been discharged from a hospitalization on or after day 0 of the trial start date and/or self-notify the VA Puget Sound of their hospitalization |
| Key exclusion criteria | 1. RNs will be excluded from eligibility if on a team Patient Aligned Care Team (PACT) of: GERI, SCI, or HBPC 2. PACTs will be excluded that had less than 1 patient visit during study time frame for their PACT primary care provider (PCP) |
| Date of first enrolment | 03/09/2025 |
| Date of final enrolment | 01/05/2026 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Seattle
98108
United States of America
Tacoma
98493
United States of America
Everett
98203
United States of America
Mount Vernon
98274
United States of America
Olympia
98506
United States of America
Puyallup
98374
United States of America
Silverdale
98383
United States of America
Port Angeles
98506
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | No additional data for this project will be collected, outside routine data collected for patient care under the Veterans Health Administration Office of Primary Care. As such, no datasets will be available for dissemination or sharing outside the institution. Analytic plans and detailed methods, outside those shared through scientific publications and conference proceedings, can be made available upon reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | 21/05/2025 | No | No |
Additional files
- 47365 SAP_Discharge Planning.pdf
- Statistical Analysis Plan
Editorial Notes
10/09/2025: The date of first enrolment was changed from 01/09/2025 to 03/09/2025.
20/08/2025: The following changes were made to the trial record:
1. The date of first enrolment was changed from 28/07/2025 to 01/09/2025.
2. The date of final enrolment was changed from 15/08/2025 to 01/05/2026.
3. The completion date was changed from 15/03/2026 to 15/06/2026.
15/07/2025: The date of first enrolment was changed from 15/07/2025 to 28/07/2025.
17/06/2025: The recruitment end date was changed from 15/01/2026 to 15/08/2025.
11/06/2025: The following changes were made to the trial record:
1. The recruitment start date was changed from 26/05/2025 to 15/07/2025.
2. The recruitment end date was changed from 30/06/2025 to 15/01/2026.
3. The overall end date was changed from 31/12/2025 to 15/03/2026.
20/05/2025: Trial's existence confirmed by Department of Veterans Affairs
