Clinical trial NCT03788096: Peer Support for Post Intensive Care Syndrome Self-Management
Official title: Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Social Network Index
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 1-week Post-intervention
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 3 months post-intervention
measure: Social Network Index
timeFrame: 1-week Post-intervention
measure: Patient Activation Measure
timeFrame: 1-week Post-intervention
measure: Patient Activation Measure
timeFrame: 3 months post-intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
timeFrame: 1-week Post-intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
timeFrame: 3 months post-intervention
measure: Short Form-36 (SF-36)
timeFrame: 1-week Post-intervention
measure: Short Form-36 (SF-36)
timeFrame: 3 months post-intervention
Other outcomes:
measure: Health services utilization
timeFrame: 1-week Post-intervention
measure: Health services utilization
timeFrame: 3 months post intervention
Locations:
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
Study officials:
References: