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Peer Support for Post Intensive Care Syndrome Self-Management

NCT ID: NCT03788096

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2021-01-27

Brief Summary

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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

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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.

Conditions

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Critical Illness Sepsis Shock, Septic Shock Respiratory Failure Respiratory Distress Syndrome, Adult Shock, Hypovolemic Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Peer Support with Motivational Interviewing

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Usual Care Group

Intervention Type BEHAVIORAL

Usual care.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care Group

Usual care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Valerie Danesh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baylor Scott & White Health

Temple, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Richard Hao

Role: primary

[email protected]
214-265-3683

Other Identifiers

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2018-08-0097

Identifier Type: -

Identifier Source: org_study_id