Peer Support for Post Intensive Care Syndrome Self-Management

Sepsis Clinical Trial

— PS-PICS  

Official title:

Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788096
• Other study ID #: 2018-08-0097
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: January 27, 2021

Study information

• Verified date: October 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 27, 2021
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Chronic Disease
• Critical Illness
• Hypovolemia
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis
• Shock
• Shock, Hypovolemic
• Shock, Septic
• Syndrome

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Baylor Scott & White Health	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health services utilization	Utilization of health services	1-week Post-intervention
Other	Health services utilization	Utilization of health services	3 months post intervention
Primary	Social Network Index	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.	3 months post-intervention
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	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.	1-week Post-intervention
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	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.	3 months post-intervention
Secondary	Social Network Index	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.	1-week Post-intervention
Secondary	Patient Activation Measure	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.	1-week Post-intervention
Secondary	Patient Activation Measure	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.	3 months post-intervention
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale	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.	1-week Post-intervention
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale	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	3 months post-intervention
Secondary	Short Form-36 (SF-36)	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	1-week Post-intervention
Secondary	Short Form-36 (SF-36)	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	3 months post-intervention