TelePORT Pilot Study

NCT03926533 | Completed

• 1 other identifier: 190790
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. The long-term goal of this study is to develop and refine in-person and telehealth strategies for the delivery of Intensive Care Unit (ICU) recovery care for the treatment of PICS.

Conditions

Critical Illness; Acute Respiratory Distress Syndrome; Septic Shock

Keywords

Post-Intensive Care Syndrome

Outcome Measures

Primary Outcomes (3)

• Acceptability

  participants will complete the 4-item Likert response Acceptability of Intervention Measure (AIM) of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater acceptability. Scores are based on calculated mean.

  6 months

• participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM)

  participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM) of perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater feasibility. Scores are based on calculated mean.

  6 months

• Appropriateness

  participants will complete the 4-item Likert response Intervention Appropriateness Measure (IAM) of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater appropriateness. Scores are based on calculated mean.

  6 months

Secondary Outcomes (6)

• cognitive impairment

  6 months

• depression

  6 months

• physical impairments

  6 months

• QOL

  6 months

• anxiety

  6 months

Study Arms (2)

Telehealth ICU Recovery Program

EXPERIMENTAL

Components of the ICU RC telehealth visit will be structured parallel to what is done during a typical in-person clinic visit. The telehealth intervention consists of 5 chronological components conducted during two 1.5 hour telehealth clinic visits (the same time required for an in-person visit). Upon completion of the pre-intervention baseline assessment, the study coordinator will contact patients randomized to the intervention arm to schedule the first telehealth visit. Study visits will occur at 3 weeks and 3 months following hospital discharge.

Other: Telehealth

Standard Recovery Conditions

NO INTERVENTION

participants assigned to the standard of care control group will be contacted by the study coordinator to ensure the patient has a primary care and/or specialist appointment scheduled. At this time, patients will also receive an electronic PICS guide for ICU survivors created by the Society of Critical Care Medicine. Patients will be directed to use the information provided in the PICS guide for ICU survivors to connect with resources.

Interventions

Telehealth OTHER

Telehealth visits will be conducted from a private telehealth lab room in the Vanderbilt ICU Recovery Center using a live and interactive approach where providers and patients interact and communicate in real-time using Zoom, a secure video-conferencing platform recommended by Vanderbilt Telehealth.

Telehealth ICU Recovery Program

Eligibility Criteria

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

You may qualify if:

• index ICU stay with a diagnosis of sepsis or acute respiratory distress syndrome projected to be discharged alive as these patients are at the highest risk for developing PICS

You may not qualify if:

• no access to computer, electronic device (e.g., tablet, smartphone), and/or internet connection for virtual clinic visit,
• primary care received outside of VUMC network,
• hospice care at discharge,
• substance abuse or psychiatric disorder that prevents independent living,
• blind, deaf, unable to speak English, or
• severe dementia prior to index hospitalization

Sponsors & Collaborators

• Vanderbilt University: lead
• American Association of Critical Care Nurses: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37129, United States

Location

Related Publications (8)

• Boehm LM, Danesh V, LaNoue M, Trochez RJ, Jones AC, Kimpel CC, Sevin CM. Factors Influencing Engagement with in-Person Intensive Care Unit Recovery Clinic Services. J Intensive Care Med. 2023 Apr;38(4):375-381. doi: 10.1177/08850666221127154. Epub 2022 Sep 21.

  PMID: 36128790 BACKGROUND

• Boehm LM, Danesh V, Eaton TL, McPeake J, Pena MA, Bonnet KR, Stollings JL, Jones AC, Schlundt DG, Sevin CM. Multidisciplinary ICU Recovery Clinic Visits: A Qualitative Analysis of Patient-Provider Dialogues. Chest. 2023 Apr;163(4):843-854. doi: 10.1016/j.chest.2022.10.001. Epub 2022 Oct 13.

  PMID: 36243061 RESULT

• Kovaleva MA, Jones AC, Kimpel CC, Lauderdale J, Sevin CM, Stollings JL, Jackson JC, Boehm LM. Patient and caregiver experiences with a telemedicine intensive care unit recovery clinic. Heart Lung. 2023 Mar-Apr;58:47-53. doi: 10.1016/j.hrtlng.2022.11.002. Epub 2022 Nov 15.

  PMID: 36399862 RESULT

• Kovaleva MA, Jones AC, Kimpel CC, Lauderdale JL, Sevin CM, Boehm LM. Patients' and Caregivers' Perceptions of Intensive Care Unit Hospitalization and Recovery. Am J Crit Care. 2022 Jul 1;31(4):319-323. doi: 10.4037/ajcc2022945.

  PMID: 35773198 RESULT

• Eaton TL, Danesh V, Jones AC, Kimpel CC, Sevin CM, Su H, Toth KM, Valley TS, Iwashyna TJ, Boehm LM, McPeake J. Clinician and Patient Responses to US Health Insurers' Policies: A Qualitative Study of Higher Risk Patients. Health Serv Res. 2025 Jun;60(3):e14615. doi: 10.1111/1475-6773.14615. Epub 2025 Apr 24.

  PMID: 40275640 DERIVED

• Hussain AA, Jones AC, Hosey MM, Kiehl A, Danesh V, McPeake J, Toth K, Eaton TL, Su H, Jackson JC, Boehm LM. Patient-psychologist telemedicine interactions in an intensive care unit recovery clinic: Qualitative secondary analysis. Intensive Crit Care Nurs. 2025 Apr;87:103886. doi: 10.1016/j.iccn.2024.103886. Epub 2024 Nov 21.

  PMID: 39577128 DERIVED

• Carter SJ, Lauderdale J, Stollings JL, Sevin CM, Cunningham-Erves J, Kokoy S, Clouse K, Boehm LM. Factors Influencing Influenza and COVID-19 Vaccine Decision-Making in the Post-ICU Period: A Secondary Analysis. CHEST Crit Care. 2023 Dec;1(3):100027. doi: 10.1016/j.chstcc.2023.100027. Epub 2023 Oct 23.

  PMID: 38188262 DERIVED

• Danesh V, McDonald AD, McPeake J, Eaton TL, Potter K, Su H, Jackson JC, Boehm LM. Driving decisions after critical illness: Qualitative analysis of patient-provider reviews during ICU recovery clinic assessments. Int J Nurs Stud. 2023 Oct;146:104560. doi: 10.1016/j.ijnurstu.2023.104560. Epub 2023 Jul 4.

  PMID: 37531701 DERIVED

Related Links

• The ICU Recovery Center at Vanderbilt

MeSH Terms

Conditions

Critical Illness; Respiratory Distress Syndrome; Shock, Septic; postintensive care syndrome

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: November 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: February 28, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)