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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788096
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Valerie Danesh, 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.

Condition or disease Intervention/treatment Phase
Critical Illness Sepsis Shock, Septic Shock Respiratory Failure Respiratory Distress Syndrome, Adult Shock, Hypovolemic Chronic Disease Behavioral: Peer Support with Motivational Interviewing Behavioral: Usual Care Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: 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.
Behavioral: Usual Care Group
Usual care.




Primary Outcome Measures :
  1. Social Network Index [ Time Frame: 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 :
  1. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 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.

  2. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 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.

  3. Social Network Index [ Time Frame: 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.

  4. Patient Activation Measure [ Time Frame: 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.


  5. Patient Activation Measure [ Time Frame: 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.


  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale [ Time Frame: 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.


  7. Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale [ Time Frame: 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


  8. Short Form-36 (SF-36) [ Time Frame: 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


  9. Short Form-36 (SF-36) [ Time Frame: 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



Other Outcome Measures:
  1. Health services utilization [ Time Frame: 1-week Post-intervention ]
    Utilization of health services

  2. Health services utilization [ Time Frame: 3 months post intervention ]
    Utilization of health services



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Valerie Danesh, Assistant Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03788096    
Other Study ID Numbers: 2018-08-0097
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valerie Danesh, University of Texas at Austin:
Post-Intensive Care Syndrome (PICS)
Chronic Critical Illness
Additional relevant MeSH terms:
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Shock, Septic
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Syndrome
Shock
Critical Illness
Chronic Disease
Hypovolemia
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Disease Attributes
Lung Injury
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation