Care for Veterans Post-COVID-19

NCT05787379 | Recruiting DMC

• 1 other identifier: SDR 23-001
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. This is consistent with published expert opinion that Concordant Care underlies patients' (and clinicians') positive experiences of care for poorly understood conditions. Despite strong evidence supporting this care approach, there are no interventions to train clinicians on practices to provide Concordant Care for Veterans with poorly understood conditions such as Long-COVID. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. This study will adapt and refine Concordant Care training for Long-COVID. Part 2 of this study will determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, \& disability for Veterans with Long-COVID. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

training; COVID-19; post-acute sequelae of COVID infection

Outcome Measures

Primary Outcomes (2)

• Concordant Care Practice Change

  Concordant Care practices will be measured with the 11-item measure that asks the patient if the clinician talked with them about multiple dimensions of their understanding of the health condition (i.e., cause, consequence, treatment). Participants answer yes or no to each question. Scores range from 0 to 11 with a higher score = more Concordant Care practices.

  Baseline and 3-months

• Concordance of Illness Perceptions Questionnaire Change

  Shared Understanding will be captured with the concordance of illness perceptions questionnaire, a 6-item validated measure of shared understanding of the 5 components of illness perception between patients and clinicians. Veterans respond on a 5-point Likert scale. Scores range from 6 to 30 with higher scores = greater concordant understanding.

  Baseline and 3-months

Secondary Outcomes (3)

• Patient Satisfaction Questionnaire (PSQ-III)

  Baseline and 3-months

• Medical Outcomes Survey Adherence Scale

  Baseline and 3-months

• Veterans Rand (VR-12)

  Baseline and 3-months

Study Arms (2)

Providers receiving Long-COVID Concordant Care Training

EXPERIMENTAL

Providers randomized to this arm will receive concordant care training.

Behavioral: Concordant Care Training

Providers receiving Education Packet Training

ACTIVE COMPARATOR

Providers randomized to this arm will receive education packet training.

Behavioral: Education Packet Training

Interventions

Concordant Care Training BEHAVIORAL

Concordant Care training has four components. 1. Clinicians will complete \~3 hours of online, asynchronous training that will teach them practices including validate Veterans' experiences with Long-COVID, develop shared understanding with patients about Long-COVID, and develop patient-centered action plans. Clinicians will be provided with handouts, case examples, video demonstrations, and practice exercises to help them integrate these practices into care. 2. Tele-mentoring groups will be offered \~bi-weekly and be open to all clinician participant in the Concordant Training arm. Content will include review of specific cases, didactics on specific Concordant Care practices, role-play exercises, and review of session recordings. At least two sessions are required. 3. Clinician Pocket Card that serves as a reminder of the Concordant Care process. 4. An electronic prompt will be sent to enrolled Veterans encouraging them to speak with their clinician about their Long-COVID concerns.

Providers receiving Long-COVID Concordant Care Training

Education Packet Training BEHAVIORAL

Clinicians randomized to the control arm will receive a comprehensive information packet with the latest understanding of Long-COVID. Clinicians will also be provided a packet directing them to relevant VA trainings for Long-COVID. Whole Health trainings which focus on wholistic integrated approaches to care will be highlighted. Whole Health is important for all Veterans, and it is thought to be particularly relevant for poorly understood conditions that don't easily fit in traditional medical model.

Providers receiving Education Packet Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1 and Part 2, English-speaking VA primary care providers will be included.
• Part 1, Veterans who self-identify as having Long-COVID will be included.
• Part 2, Veterans who meet criteria for Long-COVID assessed with modified DePaul Symptom Questionnaire version 2 will be included;
• Part 2, Veterans must also have a scheduled appointment with one of the participating clinicians within one to six months of the clinician being consented.

You may not qualify if:

• Part 1 and Part 2, clinicians who have already taken Concordant Care training will be excluded.
• Part 1, Veterans will be excluded if they are not receiving care in the VA.
• Part 2, Veterans will be excluded if they were in the Intensive Care Unit (ICU) for COVID-19.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, 07018, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Marie McAndrew, PhD

  East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M McAndrew, PhD

CONTACT

(862) 400-3317; Lisa.Mcandrew@va.gov

Shannon Nugent, PhD

CONTACT

(503) 220-8262; shannon.nugent@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. The training involves four components: completion of approx. 3 hours of online, asynchronous training; attendance to at least two tele-mentoring sessions to review specific cases, didactics, role-play exercises, and session recordings; obtaining a clinician pocket care with reminders of Concordant Care process; and being prompted by a Veteran patient to talk about their concerns with Long-COVID.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: March 28, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)