## Protocol Section
### Identification Module
**NCT ID:** NCT05787379

**Brief Title:** Care for Veterans Post-COVID-19

**Official Title:** Leveraging Knowledge of Chronic Multisymptom Illness to Improve Care for Veterans Post-COVID

#### Organization Study ID Info
**ID:** SDR 23-001
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2027-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-06

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-05

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-10-01

**Type:** ESTIMATED

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2023-03-28
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-23
**Study First Submit QC Date:** 2023-03-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** VA Office of Research and Development

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed Description:** This is a two-part study. 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. 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. Concordant Care will be adapted through interviews and focus groups with Veterans with Long-COVID (estimated n=9) and primary care providers (estimated n=21). Feedback from the participants will help refine and test Concordant Care training. 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. Part 2 will be a randomized parallel cluster trial with primary care clinicians (n=60) separated into a Concordant Care training group and an education packet control group. Veterans (n=240) who have an upcoming appointment with their primary care provider who is a participant in the study will be recruited. The Veterans will be assessed at baseline before their appointment and approximately 3-months later after their appointment. 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 Module

**Conditions:**

- Post-Acute COVID-19 Syndrome

**Keywords:**

- training

- COVID-19

- post-acute sequelae of COVID infection

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 348

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Providers randomized to this arm will receive concordant care training.

**Intervention Names:**

- Behavioral: Concordant Care Training

**Label:** Providers receiving Long-COVID Concordant Care Training

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Providers randomized to this arm will receive education packet training

**Intervention Names:**

- Behavioral: Education Packet Training

**Label:** Providers receiving Education Packet Training

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Providers receiving Long-COVID Concordant Care Training

**Description:** 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.

**Name:** Concordant Care Training

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Providers receiving Education Packet Training

**Description:** 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.

**Name:** Education Packet Training

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Concordant Care Practice Change

**Time Frame:** Baseline and 3-months

**Description:** 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.

**Measure:** Concordance of Illness Perceptions Questionnaire Change

**Time Frame:** Baseline and 3-months

#### Secondary Outcomes

**Description:** The 18-item PSQ measures patient satisfaction in health care services and has been used specifically to assess patient satisfaction of VA healthcare services. Response options are 1-5 with 1=strongly agree and 5=strongly disagree. Scores range from 18 to 90 with higher scores = greater satisfaction with medical care.

**Measure:** Patient Satisfaction Questionnaire (PSQ-III)

**Time Frame:** Baseline and 3-months

**Description:** The Medical Outcomes Survey Adherence 5-item scale captures Veterans adherence to primary care clinician's recommendations. Scores range from 6 to 30 with greater scores = better adherence.

**Measure:** Medical Outcomes Survey Adherence Scale

**Time Frame:** Baseline and 3-months

**Description:** Veterans Rand 12-item Health Survey (VR-12). The VR-12 is a well-validated quality of life measure that assesses multiple domains of physical and mental health functioning. Scores range from 0 to 100 with higher scores = less disability.

**Measure:** Veterans Rand (VR-12)

**Time Frame:** Baseline and 3-months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Lisa.Mcandrew@va.gov

**Name:** Lisa M McAndrew, PhD

**Phone:** (862) 400-3317

**Role:** CONTACT

**Contact 2:**

**Email:** shannon.nugent@va.gov

**Name:** Shannon Nugent, PhD

**Phone:** (503) 220-8262

**Phone Ext:** 51721

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** East Orange

**Contacts:**

***Contact 1:***

- **Email:** amanda.matteson@va.gov

- **Name:** Amanda L Matteson

- **Phone:** (973) 676-1000

- **Phone Ext:** 203580

- **Role:** CONTACT

***Contact 2:***

- **Email:** nicole.whittaker2@va.gov

- **Name:** Nicole Whittaker, MSW

- **Phone:** (973) 676-1000

- **Phone Ext:** 201167

- **Role:** CONTACT

***Contact 3:***

- **Name:** Lisa Marie McAndrew, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

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

**State:** New Jersey

**Zip:** 07018

#### Overall Officials

**Official 1:**

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

**Name:** Lisa Marie McAndrew, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000094025

- Term: Post-Infectious Disorders

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3013

- Name: Post-Acute COVID-19 Syndrome

- Relevance: HIGH

- As Found: Post-Acute COVID-19 Syndrome

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3014

- Name: Post-Infectious Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000094024

- Term: Post-Acute COVID-19 Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
