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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Shock; Critical Illness; Shock, Septic; Respiratory Failure; Chronic Disease; Respiratory Distress Syndrome, Adult; Shock, Hypovolemic
• Intervention / Treatment: Behavioral: Peer Support with Motivational Interviewing; Behavioral: Usual Care 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Recruiting
      • Baylor Scott & White Health
      • Contact: Richard Hao; Phone Number: 214-265-3683; Email: Richard.Hao@BSWHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PS-PICS Peer Support Intervention; 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.	Behavioral: Peer Support with Motivational Interviewing; Mentors will trained in motivational interviewing and will conduct weekly telephone calls with participants randomized to the PS-PICS peer support intervention arm.
Placebo Comparator: Usual Care Group; 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.	Behavioral: Usual Care Group; Usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-week Post-intervention
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.	3 months post-intervention
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.	1-week Post-intervention
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.	1-week Post-intervention
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.	3 months post-intervention
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.	1-week Post-intervention
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	3 months post-intervention
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	1-week Post-intervention
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	3 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health services utilization	Utilization of health services	1-week Post-intervention
Health services utilization	Utilization of health services	3 months post intervention

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Anticipated): October 27, 2020
• Study Completion (Anticipated): January 27, 2021

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Post-Intensive Care Syndrome (PICS); Chronic Critical Illness
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Disease; Infant, Newborn, Diseases; Sepsis; Lung Injury; Infant, Premature, Diseases; Syndrome; Shock, Septic; Respiratory Insufficiency; Shock; Chronic Disease; Critical Illness; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Hypovolemia
• Other Study ID Numbers: 2018-08-0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No