Peer Support for Post Intensive Care Syndrome Self-Management

Not Applicable

• Conditions: Respiratory Failure; Shock, Hypovolemic; Critical Illness; Shock, Septic; Chronic Disease; Respiratory Distress Syndrome, Adult; Sepsis; Shock

• Registration Number: NCT03788096
• Lead Sponsor: University of Texas at Austin

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.

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-27
• Study Start: 2020-04-20
• Status Verified: 2020-10
• Primary Completion: 2020-10-27
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-02
• Study Completion: 2021-01-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Social Network Index	3 months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Center for Epidemiologic Studies Depression Scale (CES-D)	3 months post-intervention	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.
Patient Activation Measure	3 months post-intervention	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.
Social Network Index	1-week Post-intervention	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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale	3 months post-intervention	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
Short Form-36 (SF-36)	3 months post-intervention	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

Trial Locations

Locations (1)

Baylor Scott & White Health; 🇺🇸 Temple, Texas, United States