Chronic Disease, Critical Illness, Respiratory Distress Syndrome, Adult, Respiratory Failure, Sepsis, Shock, Shock, Hypovolemic, Shock, Septic
Conditions
Keywords
Post-Intensive Care Syndrome (PICS), Chronic Critical Illness
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.
Interventions
BEHAVIORALPeer 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.
BEHAVIORALUsual Care Group
Usual care.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale (CES-D) | 1-week 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. |
| 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 | 1-week Post-intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale 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. |
| Short Form-36 (SF-36) | 1-week 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 |
| Patient Activation Measure | 1-week 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health services utilization | 1-week Post-intervention | Utilization of health services |
Countries
United States
Outcome results
None listed