Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care (TelePORT)
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ClinicalTrials.gov Identifier: NCT06014931 |
Recruitment Status :
Recruiting
First Posted : August 28, 2023
Last Update Posted : March 1, 2024
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Condition or disease | Intervention/treatment | Phase |
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Post-intensive Care Syndrome | Behavioral: Telemedicine ICU Recovery Clinic Visit | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 202 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care |
Actual Study Start Date : | February 14, 2024 |
Estimated Primary Completion Date : | November 30, 2027 |
Estimated Study Completion Date : | May 31, 2028 |
Arm | Intervention/treatment |
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Experimental: Telemedicine ICU Recovery Clinic
scheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility
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Behavioral: Telemedicine ICU Recovery Clinic Visit
Multidisciplinary clinic visit that encompasses a medical examination, medication management, neuropsychological exam with focused psychotherapy, case management, and patient-centered consultation. |
No Intervention: Standard Recovery Conditions (i.e., Control)
Control group participants will proceed with follow-up as determined by the discharging hospital team and directed to use the provided PICS guide to connect with commonly used resources.
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- Cognitive function - MoCA [ Time Frame: 6 months ]The Montreal Cognitive Assessment-Blind is a 13-item widely used research measure for cognitive function that assesses memory, attention, language, recall, orientation, and abstraction. Test scores range from 0 (worst) to 22 (best) with a score below 18 being abnormal. Individual tasks on the MoCA-Blind are relatively difficult, reflecting less of a ceiling effect than comparable tools. Among widely used global screening measures, the MoCA has been consistently found to be the most sensitive in identifying even mild expressions of cognitive impairment.
- Cognitive function - PROMIS [ Time Frame: 6 months ]The PROMIS Cognitive Function is an 8-item patient-reported outcome measure assessing patient-perceived changes in mental acuity, verbal/nonverbal memory, verbal fluency, and concentration. Raw scores are converted to a standardized T-score with a mean of 50. Higher T-scores indicates better cognitive function.
- Physical function - ADL [ Time Frame: 6 months ]Katz's Activities of Daily Living (ADL) is a 6-item self-report of ability to perform ADLs (e.g., bathing, dressing) independently. Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-6 with lower scores indicating greater dependence.
- Physical function - IADL [ Time Frame: 6 months ]Lawton's Instrumental Activities of Daily Living (IADL) is an 8-item self-report of independence in performing IADLs (e.g., meal preparation, finance management). Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-8 with lower scores indicating greater dependence.
- Physical function - quality of life [ Time Frame: 6 months ]EuroQol-5D-5L is a 6-item self-report questionnaire of health status. Items are scored on 5 levels of severity ranging from 'no problems' to 'extreme problems' and higher scores indicating worse quality of life.
- Mental health - PTSD [ Time Frame: 6 months ]PTSD symptoms will be measured using the Impact of Events Scale-Revised (IES-R), a 22-item tool designed to measure the subjective distress caused by traumatic events. Subjects rate each item from 0 (not at all) to 4 (extremely) to indicate the degree to which they have been bothered by a particular symptom over the past week. Total score is obtained by calculating the mean of all items. Subscale scores can be calculated for avoidance, hyperarousal, and intrusion. Higher scores indicate more distress related to the specific event being evaluated.
- Mental health - anxiety/depression [ Time Frame: 6 months ]Depression and Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report. Subjects rate each item from 0 (absence) to 3 (extreme) to indicate the degree to which they have experienced the symptom in the past 7 days. The total possible score ranges from 0-21 per subscale with more than 11 being abnormal.
- Social integration [ Time Frame: 6 months ]Berkman-Syme's Social Network Index measure of marital status, friends/family contact, church membership, and group membership. The index considers number and importance of social ties across categories using a summative measure (range: 0-4). For example, there is heavier weighting for intimate contacts (4x the weight of group membership) over church membership (2x the weight of group membership).
- Self management [ Time Frame: 6 months ]Patient Activation Measure, a 13-item survey quantifying how much someone is informed about and involved in their health care. The raw score is converted to an activation score (range: 0 [no activation] to 100 [high activation]). Domains assess importance of active role, confidence and knowledge to take action, taking action, and continuing healthy behaviors under stress.
- Post-Traumatic Growth [ Time Frame: 6 months ]Post-Traumatic Growth Inventory, a 21-item scale with higher scores indicating greater post-traumatic growtth
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults (age ≥45)
- Admitted to a medical or surgical ICU
- Treated for ARF (with mechanical ventilation) and/or septic shock (with vasopressors)
Exclusion Criteria:
- hospice care at discharge or not expected to survive 6 months
- no access to a computer or electronic device (e.g., tablet, smart phone) with cellular or WiFi connection for a telemedicine clinic visit
- substance abuse or psych disorder that prevents independent living
- inability to speak English
- severe dementia preventing independent living prior to index hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014931
Contact: Leanne M Boehm, PhD | 615-343-1051 | leanne.boehm@vanderbilt.edu |
United States, Ohio | |
Ohio State University Wexner Medical Center | Not yet recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Nathan Brummel, MD | |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Leanne Boehm, PhD, RN |
Principal Investigator: | Leanne M Boehm, PhD | Vanderbilt University |
Publications:
Responsible Party: | Leanne M Boehm, Assistant Professor, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT06014931 |
Other Study ID Numbers: |
190790-Phase 2 R01AG077644 ( U.S. NIH Grant/Contract ) |
First Posted: | August 28, 2023 Key Record Dates |
Last Update Posted: | March 1, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Sharing data generated by this project is an essential part of the proposed research. The investigators seek to make data available to the community of scientists interested in ICU recovery care, specifically related to older adults attending ICU-RCs. The TelePORT trial will yield longitudinal outcomes data from approximately 202 adults. The final data set will contain de-identified demographic information and patient outcome responses on PICS, social integration, self-management, and other exploratory outcomes. Data will be available for sharing after the publication date of the main results from the final dataset. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | after study completion |
Access Criteria: | When approval is granted, data-sharing agreements that provide for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed will be instituted. Requests for data must be made in writing and must clearly state the intended use of the requested data and expected length of time for data analyses. This request must be sent directly to the study contact PI who will record all requests for NIH reporting and secure IRB involvement in the process. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |