Peer Support for Post Intensive Care Syndrome Self-Management

NCT03788096 | Unknown DMC

• 1 other identifier: 2018-08-0097
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Center for Epidemiologic Studies Depression Scale (CES-D)

  1-week Post-intervention

• Center for Epidemiologic Studies Depression Scale (CES-D)

  3 months post-intervention

• Social Network Index

  1-week Post-intervention

• Patient Activation Measure

  1-week Post-intervention

• Patient Activation Measure

  3 months post-intervention

Other Outcomes (2)

• Health services utilization

  1-week Post-intervention

• Health services utilization

  3 months post intervention

Study Arms (2)

PS-PICS Peer Support Intervention

EXPERIMENTAL

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

Usual Care Group

PLACEBO COMPARATOR

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

Interventions

Peer Support with Motivational Interviewing BEHAVIORAL

Mentors will trained in motivational interviewing and will conduct weekly telephone calls with participants randomized to the PS-PICS peer support intervention arm.

PS-PICS Peer Support Intervention

Usual Care Group BEHAVIORAL

Usual care.

Usual Care Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Baylor Scott & White Health

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness; Sepsis; Shock, Septic; Shock; Respiratory Insufficiency; Respiratory Distress Syndrome; Chronic Disease; postintensive care syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

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

Model Details: A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 27, 2018
• Study Start: April 20, 2020
• Primary Completion: October 27, 2020
• Study Completion: January 27, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

US (1)