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Care for Veterans Post-COVID-19

Primary Purpose

Post-Acute COVID-19 Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Concordant Care Training
Education Packet Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-Acute COVID-19 Syndrome focused on measuring training, COVID-19, post-acute sequelae of COVID infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Providers receiving Long-COVID Concordant Care Training

Providers receiving Education Packet Training

Arm Description

Providers randomized to this arm will receive concordant care training.

Providers randomized to this arm will receive education packet training

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Patient Satisfaction Questionnaire (PSQ-III)
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.
Medical Outcomes Survey Adherence Scale
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.
Veterans Rand (VR-12)
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.

Full Information

First Posted
March 23, 2023
Last Updated
October 5, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05787379
Brief Title
Care for Veterans Post-COVID-19
Official Title
Leveraging Knowledge of Chronic Multisymptom Illness to Improve Care for Veterans Post-COVID
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19 Syndrome
Keywords
training, COVID-19, post-acute sequelae of COVID infection

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Providers receiving Long-COVID Concordant Care Training
Arm Type
Experimental
Arm Description
Providers randomized to this arm will receive concordant care training.
Arm Title
Providers receiving Education Packet Training
Arm Type
Active Comparator
Arm Description
Providers randomized to this arm will receive education packet training
Intervention Type
Behavioral
Intervention Name(s)
Concordant Care Training
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Education Packet Training
Intervention 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.
Primary Outcome Measure Information:
Title
Concordant Care Practice Change
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.
Time Frame
Baseline and 3-months
Title
Concordance of Illness Perceptions Questionnaire Change
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.
Time Frame
Baseline and 3-months
Secondary Outcome Measure Information:
Title
Patient Satisfaction Questionnaire (PSQ-III)
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.
Time Frame
Baseline and 3-months
Title
Medical Outcomes Survey Adherence Scale
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.
Time Frame
Baseline and 3-months
Title
Veterans Rand (VR-12)
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.
Time Frame
Baseline and 3-months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa M McAndrew, PhD
Phone
(862) 400-3317
Email
Lisa.Mcandrew@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Nugent, PhD
Phone
(503) 220-8262
Ext
51721
Email
shannon.nugent@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Marie McAndrew, PhD
Organizational Affiliation
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda L Matteson
Phone
(973) 676-1000
Ext
203580
Email
amanda.matteson@va.gov
First Name & Middle Initial & Last Name & Degree
Nicole Whittaker, MSW
Phone
(973) 676-1000
Ext
201167
Email
nicole.whittaker2@va.gov
First Name & Middle Initial & Last Name & Degree
Lisa Marie McAndrew, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Care for Veterans Post-COVID-19

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