Impact of a novel post-discharge clinic on post-hospital follow-up among Veterans
| ISRCTN | ISRCTN86866399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86866399 |
| Secondary identifying numbers | PCIL-DC-Clinic |
- Submission date
- 19/05/2025
- Registration date
- 23/05/2025
- Last edited
- 20/08/2025
- Recruitment status
- Not yet 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
| Study design | Single-center prospective cluster-randomized quality improvement trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice, Hospital, Pharmacy |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | No participant information sheet available. |
| 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 | 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 |
| Secondary outcome measures | Secondary outcome measures: 1. 28-day count of VA and community care (IVC) hospital readmissions (patient-level), 2. 28-day count of ER visits, VA and community care (IVC) (patient-level) Other prespecified outcome measures: 3. PC utilization post-RN call (outpatient visits - total, and by modality (in-person, VVC, telephone)) within 45-days. 4. Combined ER / urgent care post-RN call, by 28-days. 5. Total prescription medications (controlling for baseline/pre-intervention) at 28 days. 6. Medications discontinued and by type of reason for discontinuation, between index RN call and 28 days. 7. Medication safety events (adverse drug / allergy events), between index RN call and 12 days 8. Post-hospital discharge summary availability among patients with no discharge summary at time of index RN call, by first Licensed Independent Practitioner (LIP) appointment in primary care. |
| Overall study start date | 19/05/2025 |
| Completion date | 15/06/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient, Employee |
|---|---|
| Age group | All |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 13 pods/clusters; 600 patients with ~45 patients per pod/cluster |
| 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 | 01/09/2025 |
| 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
Sponsor information
Government
1660 S Columbian Way
Seattle
98108
United States of America
| Phone | +1 206-769-4074 |
|---|---|
| John.Messina@va.gov | |
| Website | http://www.pugetsound.va.gov/ |
"ROR" |
https://ror.org/00ky3az31 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- VA Health Services Research and Development Service, VA HSR&D, Veterans Health Administration HSR and D, HSR&D
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results from this study will be disseminated among the health system stakeholders and clinical leadership, consistent with the project designation as an operationally focused quality improvement project, to help resolve questions of system optimization. Generalizable findings from this work will also be analyzed and disseminated for wider audiences through peer-reviewed manuscripts and/or for topical scientific conferences. |
| 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? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 21/05/2025 | No | No |
Additional files
Editorial Notes
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
