Critical IllnessPS-PICSNCT03788096
Peer Support for Post Intensive Care Syndrome Self-Management
A study testing Peer Support with Motivational Interviewing in people with Critical Illness and Sepsis, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critical Illness, Sepsis, Shock, Septic
- What is being tested?
- Peer Support with Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- death prior to hospital discharge
- enrollment in Hospice services at the time of hospital discharge
- non-communicative
- no access to telephone
- incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White Health
Temple, Texas, 76508
Richard Hao, 214-265-3683, Richard.Hao@BSWHealth.org
About this study
Official title: Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)
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.
Read the 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.
- Conditions
- Critical Illness, Sepsis, Shock, Septic, Shock, Respiratory Failure, Respiratory Distress Syndrome, Adult
- Being tested
- Peer Support with Motivational Interviewing, Usual Care Group
- Keywords
- Post-Intensive Care Syndrome (PICS), Chronic Critical Illness
- Medical subject headings
- Critical Illness, Sepsis, Shock, Septic, Shock, Respiratory Insufficiency, Respiratory Distress Syndrome, Chronic Disease, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Support with Motivational InterviewingBehavioural
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 GroupBehavioural
Usual care.
| Study group | Role | What they receive |
|---|---|---|
| PS-PICS Peer Support Intervention | Experimental | 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. Receives: Behavioral: Peer Support with Motivational Interviewing |
| Usual Care Group | Placebo comparator | 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. Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-intervention
Secondary outcomes (9)
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.
Measured: 1-week Post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 1-week Post-intervention
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.
Measured: 1-week Post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 1-week Post-intervention
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
Measured: 3 months post-intervention
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
Measured: 1-week Post-intervention
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
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start20 Apr 2020
- Primary completion27 Oct 2020 (estimated)
- Study completion27 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Danesh, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788096
- Sponsor's protocol ID
- 2018-08-0097
- Acronym
- PS-PICS
- Status last verified
- Oct 2020
- First submitted
- 20 Nov 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)
- ClinicalTrials.gov ID
- NCT03788096
- Acronym / sponsor ID
- PS-PICS / 2018-08-0097
- Conditions
- Critical Illness, Sepsis, Shock, Septic, Shock, Respiratory Failure, Respiratory Distress Syndrome, Adult
- Keywords
- Post-Intensive Care Syndrome (PICS), Chronic Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 27 Oct 2020 (estimated)
- Study completion
- 27 Jan 2021 (estimated)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design.
| Arm | Type | Receives |
|---|---|---|
| PS-PICS Peer Support Intervention | Experimental | Behavioral: Peer Support with Motivational InterviewingICU 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. |
| Usual Care Group | Placebo comparator | Behavioral: Usual Care GroupA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- death prior to hospital discharge
- enrollment in Hospice services at the time of hospital discharge
- non-communicative
- no access to telephone
- incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Support with Motivational InterviewingMentors will trained in motivational interviewing and will conduct weekly telephone calls with participants randomized to the PS-PICS peer support intervention arm. | Behavioural | PS-PICS Peer Support Intervention |
| Usual Care GroupUsual care. | Behavioural | Usual Care Group |
Primary outcome
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.
9 secondary outcomes
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 1-week Post-intervention
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 3 months post-intervention
Social Network Index
Time frame: 1-week Post-intervention
Patient Activation Measure
Time frame: 1-week Post-intervention
Patient Activation Measure
Time frame: 3 months post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Time frame: 1-week Post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Time frame: 3 months post-intervention
Short Form-36 (SF-36)
Time frame: 1-week Post-intervention
Short Form-36 (SF-36)
Time frame: 3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support with Motivational Interviewing in people with Critical Illness and Sepsis, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Network Index (time frame: 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.