Recruiting

Observational Study

Sponsor:

University of Texas at Austin

Code:

NCT03788096

Conditions

Critical Illness

Sepsis

Shock, Septic

Shock

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Peer Support with Motivational Interviewing

Usual Care Group

Study Details

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

Study ID

NCT03788096

Start date

Apr 20, 2020

Status verified date

Oct, 2020

Completion date

Jan 27, 2021

Anticipated

Primary completion date

Oct 27, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Usual Care Group

Usual care.

Primary outcome measure

  • Social Network Index [ Time Frame: 3 months post-intervention ]

Central Contacts and Locations

Locations

Baylor Scott & White Health

Recruiting

Temple, Texas, United States, 76508

Contacts

Richard Hao

214-265-3683Richard.Hao@BSWHealth.org

More Information

Sponsor

University of Texas at Austin

Last update posted

Nov 2, 2020

Last verified

Oct, 2020

Keywords

  • Post-Intensive Care Syndrome (PICS)
  • Chronic Critical Illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2020-11-02.