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Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)

Primary Purpose

Critical Illness, Sepsis, Shock, Septic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Support with Motivational Interviewing
Usual Care Group
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Post-Intensive Care Syndrome (PICS), Chronic Critical Illness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age18 years or older
  • ICU length of stay 8 days or longer
  • expected to survive hospitalization with a discharge destination to home within 28 days of hospital discharge
  • diagnosed with 2 or more chronic conditions.

Exclusion Criteria:

  • death prior to hospital discharge
  • enrollment in Hospice services at the time of hospital discharge
  • non-communicative
  • no access to telephone
  • incarcerated

Sites / Locations

  • Baylor Scott & White HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PS-PICS Peer Support Intervention

Usual Care Group

Arm Description

ICU mentors will be responsible for providing support to survivor participants randomized to the PS-PICS peer support intervention. Mentors will be trained in motivational interviewing techniques to engage mentees in goal setting and emotional management that is not readily accessible as part of discharge planning.

A control intervention will be used to provide comparison data consistent with usual care (absence of structured peer support telephone intervention) to evaluate the impact of the PS-PICS peer support intervention.

Outcomes

Primary Outcome Measures

Social Network Index
Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.

Secondary Outcome Measures

Center for Epidemiologic Studies Depression Scale (CES-D)
Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.
Center for Epidemiologic Studies Depression Scale (CES-D)
Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.
Social Network Index
Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.
Patient Activation Measure
Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness. The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.
Patient Activation Measure
Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness. The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?). The maximum total score is 65. Higher values represent higher levels of fatigue.
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
The Measure includes a scale. Please provide the following scale information: Specify the full (unabbreviated) scale name and construct (i.e., indicate what the scale measures if not clear from name). Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values. For example, if the *total* score is reported, the *total* range should be provided. If *subscale* scores are reported, the range for each *subscale* should be provided. The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?). The maximum total score is 65. Higher values represent higher levels of fatigue. If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.). N/A
Short Form-36 (SF-36)
Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi
Short Form-36 (SF-36)
Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi

Full Information

First Posted
November 20, 2018
Last Updated
October 30, 2020
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03788096
Brief Title
Peer Support for Post Intensive Care Syndrome Self-Management
Acronym
PS-PICS
Official Title
Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
October 27, 2020 (Anticipated)
Study Completion Date
January 27, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design is planned. Forty CCI survivors will be randomized (1:1) to either the PS-PICS (peer support) intervention or usual care (control) group.
Detailed Description
Randomized participants will complete 4 study assessments: 1) baseline data at hospital discharge; 2) baseline data post-hospital discharge and before the start of the weekly peer support intervention; 3) post-intervention at the conclusion of the 90-day weekly peer support intervention; and 4) follow-up at 6-months post-hospital discharge. The weekly peer support intervention will be delivered by a small pool of critical illness survivor peers (mentors) recruited from the study site from previous research. Peer support mentors will be trained in peer support and MI, and will deliver 3 months of weekly MI interventions (phone-based) to CCI survivors randomized to the intervention group. Participants randomized to the usual care group will not receive the weekly peer support/MI intervention but will receive the usual discharge planning services currently provided at hospital discharge. Participants in both groups will be contacted by the research team for 4 telephone-based assessments. The design will allow us to test the feasibility and potential impact of the PS-PICS intervention on social relationship measures, depression and self-management. Data collection and analyses are guided by the Individual and Family Self-Management Theory. The Individual and Family Self-Management Theory illustrates the interaction of the process of self-management with risk and protective factors, and short-term and long-term outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Sepsis, Shock, Septic, Shock, Respiratory Failure, Respiratory Distress Syndrome, Adult, Shock, Hypovolemic, Chronic Disease
Keywords
Post-Intensive Care Syndrome (PICS), Chronic Critical Illness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PS-PICS Peer Support Intervention
Arm Type
Experimental
Arm Description
ICU mentors will be responsible for providing support to survivor participants randomized to the PS-PICS peer support intervention. Mentors will be trained in motivational interviewing techniques to engage mentees in goal setting and emotional management that is not readily accessible as part of discharge planning.
Arm Title
Usual Care Group
Arm Type
Placebo Comparator
Arm Description
A control intervention will be used to provide comparison data consistent with usual care (absence of structured peer support telephone intervention) to evaluate the impact of the PS-PICS peer support intervention.
Intervention Type
Behavioral
Intervention Name(s)
Peer Support with Motivational Interviewing
Intervention Description
Mentors will trained in motivational interviewing and will conduct weekly telephone calls with participants randomized to the PS-PICS peer support intervention arm.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Group
Intervention Description
Usual care.
Primary Outcome Measure Information:
Title
Social Network Index
Description
Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.
Time Frame
1-week Post-intervention
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Center for Epidemiologic Studies Depression Scale (CES-D) to measure self-reported symptoms of depression The scale range is 0-60. The total score will be reported. The maximum total score is 60. Higher values represent self-reported symptoms of depression. Higher values represent a worse outcome.
Time Frame
3 months post-intervention
Title
Social Network Index
Description
Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.
Time Frame
1-week Post-intervention
Title
Patient Activation Measure
Description
Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness. The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.
Time Frame
1-week Post-intervention
Title
Patient Activation Measure
Description
Patient Activation Measure (PAM) Survey to measure self-reported active behavior in the self-management of chronic illness. The scale range is 0-100. The total score will be reported. The maximum total score is 100. Higher values represent high levels of activation in self-management. Higher values represent a better outcome.
Time Frame
3 months post-intervention
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?). The maximum total score is 65. Higher values represent higher levels of fatigue.
Time Frame
1-week Post-intervention
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Description
The Measure includes a scale. Please provide the following scale information: Specify the full (unabbreviated) scale name and construct (i.e., indicate what the scale measures if not clear from name). Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values. For example, if the *total* score is reported, the *total* range should be provided. If *subscale* scores are reported, the range for each *subscale* should be provided. The scale range is 0-65. The total score will be reported. For each scale range provided, specify which values are considered to be a better or worse outcome (e.g., Do higher values represent a better or worse outcome?). The maximum total score is 65. Higher values represent higher levels of fatigue. If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.). N/A
Time Frame
3 months post-intervention
Title
Short Form-36 (SF-36)
Description
Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi
Time Frame
1-week Post-intervention
Title
Short Form-36 (SF-36)
Description
Short Form-36 (SF-36) or 36-Item Short Form Health Survey Instrument The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability Sections: ∙ Vitality ∙ Physical functioning ∙ Bodily pain ∙ General health perceptions ∙ Physical role functi
Time Frame
3 months post-intervention
Other Pre-specified Outcome Measures:
Title
Health services utilization
Description
Utilization of health services
Time Frame
1-week Post-intervention
Title
Health services utilization
Description
Utilization of health services
Time Frame
3 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age18 years or older ICU length of stay 8 days or longer expected to survive hospitalization with a discharge destination to home within 28 days of hospital discharge diagnosed with 2 or more chronic conditions. Exclusion Criteria: death prior to hospital discharge enrollment in Hospice services at the time of hospital discharge non-communicative no access to telephone incarcerated
Facility Information:
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Hao
Phone
214-265-3683
Email
Richard.Hao@BSWHealth.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Peer Support for Post Intensive Care Syndrome Self-Management

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