Critical IllnessPIC-UPSNCT03972384
A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
A study testing Post-ICU Problem Solving in people with Critical Illness and Mechanical Ventilation Complication, run by Ohio State University at 1 site in United States.
Trial summary
This study will apply an evidence based program to assist ICU survivors to overcome cognitive problems as a result of their critical illness. This study will determine feasibility of recruitment, retention and engagement with the program as well as acceptability of the program to the participants. Read more about this study
- Who is it for?
- Ages 55 to 89 years
- Conditions the study is for
- Critical Illness, Mechanical Ventilation Complication, Delirium
- What is being tested?
- Post-ICU Problem Solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 1 Mar 2023
- 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 55 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >55 years old
- discharged home following an ICU stay,
- reside at home and were functionally independent prior to admission to the ICU based on family report,
- speak and read English,
- mechanically ventilated for at least 48 hours,
- have more than one positive clinical measurement of delirium during the ICU stay,
- Montreal Cognitive Assessment score (MoCA) between 25-17.
Who cannot join
- Pre-illness diagnosis of dementia or pre-morbid cognitive impairment (IQCODE score >3.51);
- profound uncorrected visual or hearing impairment that precludes use of the telephone;
- psychiatric condition that precludes full participation in the intervention;
- substance abuse as measured by cut-off score of 2 on CAGE-Substance Abuse Screening Tool;
- discharge to hospice care.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43231
About this study
This study will apply an evidence based program to assist ICU survivors to overcome cognitive problems as a result of their critical illness. This study will determine feasibility of recruitment, retention and engagement with the program as well as acceptability of the program to the participants.
Read the detailed description
The Post-Intensive Care Unit Problem Solving (PIC-UPS) is an adaptation of a problem solving strategy developed and tested in diverse patient populations. Its effectiveness has been demonstrated in children with movement disorders or learning difficulties as well as adults with cognitive problems following acute stroke. Participants will be randomized onto usual care and intervention groups. The usual care group will complete study surveys after enrollment and 10 weeks after enrollment. The intervention group will receive the following: In the (PIC-UPS) program, participants will be engaged for 10 sessions, learning how to do skills they select as treatment goals. The first session consists of an assessment, and selecting the goals to meet during the 10 sessions. In the next sessions, conducted at the participant's home, participants practice the skills selected as treatment goals, and assisted by the study team, use strategies to help better learn and perform those skills. Some examples of tasks that others have addressed in these sessions are gardening, yoga breathing, handwriting, managing family finances, medication management, or initiating an exercise regimen. Participants will be encouraged to select tasks most relevant and problematic to their unique situation. In addition to attending the sessions, the participants will be asked to rate the sessions and asked about how useful they were in helping to achieve goals. This involves the completion of some written questionnaires and will take about a half hour.
Sample Assessment and Treatment Schedule Session Description
- Assessment session approximately one and a half hours long. Combination of questionnaires and goal setting interview. Baseline testing of 3 goals.
- Treatment session + 2 surveys, approximately one hour long.
- Treatment session 3, approximately one hour long.
- Treatment session 4, approximately one hour long.
- Treatment session 5, approximately one hour long.
- Treatment session 6, approximately one hour long.
- Treatment session 7, approximately one hour long.
- Treatment session 8, approximately one hour long.
- Treatment session 9, approximately one hour long.
- Treatment session 10, followed by first post-intervention assessments, approximately 2 hours long.
- Being tested
- Post-ICU Problem Solving
- Keywords
- Post-ICU Syndrome, Recovery, Home Discharge, Problem Solving, Adaptation
- Medical subject headings
- Critical Illness, Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-ICU Problem SolvingBehavioural
Also called PIC-UPS
We have adapted the Cognitive Orientation to Daily Occupational Performance (CO-OP) as the Post-ICU Problem Solving intervention to be delivered in the home to patients following an illness that required an ICU stay. CO-OP is a form of meta-cognitive strategy training that teaches individuals to identify and prioritize problematic daily activities, identify barriers impeding performance, generate and evaluate strategies addressing these barriers, and generalize learning through practice. Thus, strategy training teaches skills that can be used to address disability in "real-life" activities, and is integral to personalized rehabilitation services. CO-OP has been adapted in numerous settings and most recently, it is being utilized successfully in patients with acquired cognitive dysfunction following acute stroke. This represents a useful intervention, tested in similar populations with minimal risk to the participants and potential for maximal benefit for this population.
| Study group | Role | What they receive |
|---|---|---|
| Post-ICU Problem Solving | Experimental | The PIC-UPS intervention focuses on self-regulation activities and environmental cues to overcome problems with memory, planning and decision-making. The interventionist uses guided discovery, reviews progress, and emphasizes generalization and transfer to other patient-identified problems. This approach may be more acceptable to participants because they can see the relevance of tasks to everyday life. Activities such as goal-setting, self-evaluation and reflective thinking behaviors enhance self-efficacy and increase the likelihood that the individual will engage in self-management behaviors. The first session of PIC-UPS will be delivered after enrollment to those participants randomized to the intervention group. Weekly intervention sessions will be conducted by a trained interventionist and supplemented by telephone reminders to complete daily homework. Follow-up data collection will be conducted in the home by a blinded data collector three months post-enrollment. Receives: Behavioral: Post-ICU Problem Solving |
| Control Group | No intervention | Participants in the control group will complete several surveys upon enrollment and randomization. Follow-up data collection will be conducted in the home for all participants control group by a blinded data collector three months post-enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Cognitive function as measured by Self-Administered Gerocognitive Examination
Measure of the program's effect on Cognitive Function as measured using the Self-Administered Gerocognitive examination (SAGE) The maximum score is 22. A score of 17 and above is considered normal.
Measured: Week 1 and week 12
Change in development of Chronic Illness self management practices(as measured by Self-Efficacy Scale)
Determine the program's effect on Chronic Illness self- management as measured by the Self-Efficacy to Manage Chronic Disease Scale which is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).
Measured: Week 2 and Week 12
Change in medication adherence practices (as measured by Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE))
Measure change in medication Adherence by using the MedMaIDE scale that contains a maximum total score of 13.
Measured: Week 2 and Week 12
Change in participant's rate of depression as measured by Patient Health Questionnaire - 2)
Measure of the program's effect on rate of depression
Measured: Week 1 and Week 12
Change in anxiety levels as measured by Geriatric Anxiety Scale (GAS)
Measure change in participant's anxiety levels as measured by Geriatric Anxiety Scale that contains 10 questions on anxiety with a scoring scale of 1-6 = Minimal; 7-9 = Mild, 10 = Moderate; 12-30 = Severe.
Measured: Week 1 and Week 12
Change in depression levels as measured by Geriatric Depression Scale (GDS)
Measure change in participant's depression levels as measured by Geriatric Depression Scale that contains 15 questions on depression. A score of 5 or more suggests depression.
Measured: Week 1 and Week 12
Change in Health related Quality of Life by a Short Form Health Survey - 36
Measures Health Related Quality of Life
Measured: Week 1 and Week 12
Assess the effect of the Post-Intensive Care Problem Solving program through intervention completion rates
Assess the effect of the Post-intensive care program through intervention completion rates.
Measured: 15 months
Access change in participant use of the health system
Access change in frequency of use of health system by use of the health system by number of times the study participatns use emergency department services, phone calls to physicians.
Measured: Week 12
Assess change in functional independence when performing activities of daily living as measured by the Katz Activities of Daily Living Scale.
Measure change in participant's functional independence when performing activities of daily living using the Katz Activities of Daily Living Scale. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Measured: Week 1 and Week 12
Assess change in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living.
Assess changes in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living. There are eight domains of function measured with the Lawton IADL scale.
Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded.
Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: Week 1 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start21 Jan 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
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.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Two groups randomized to treatment (Post-ICU problem solving program) or usual care (no Post-ICU problem solving program).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Tate, Ohio State University
- Investigators
- Judith A Tate, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972384
- Sponsor's protocol ID
- 2019H0089
- Acronym
- PIC-UPS
- Status last verified
- Sep 2024
- First submitted
- 8 Apr 2019
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
- ClinicalTrials.gov ID
- NCT03972384
- Acronym / sponsor ID
- PIC-UPS / 2019H0089
- Keywords
- Post-ICU Syndrome, Recovery, Home Discharge, Problem Solving, Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 3 Jun 2019 (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.
This study will apply an evidence based program to assist ICU survivors to overcome cognitive problems as a result of their critical illness. This study will determine feasibility of recruitment, retention and engagement with the program as well as acceptability of the program to the participants.
Detailed description
The Post-Intensive Care Unit Problem Solving (PIC-UPS) is an adaptation of a problem solving strategy developed and tested in diverse patient populations. Its effectiveness has been demonstrated in children with movement disorders or learning difficulties as well as adults with cognitive problems following acute stroke. Participants will be randomized onto usual care and intervention groups. The usual care group will complete study surveys after enrollment and 10 weeks after enrollment. The intervention group will receive the following: In the (PIC-UPS) program, participants will be engaged for 10 sessions, learning how to do skills they select as treatment goals. The first session consists of an assessment, and selecting the goals to meet during the 10 sessions. In the next sessions, conducted at the participant's home, participants practice the skills selected as treatment goals, and assisted by the study team, use strategies to help better learn and perform those skills. Some examples of tasks that others have addressed in these sessions are gardening, yoga breathing, handwriting, managing family finances, medication management, or initiating an exercise regimen. Participants will be encouraged to select tasks most relevant and problematic to their unique situation. In addition to attending the sessions, the participants will be asked to rate the sessions and asked about how useful they were in helping to achieve goals. This involves the completion of some written questionnaires and will take about a half hour.
Sample Assessment and Treatment Schedule Session Description
- Assessment session approximately one and a half hours long. Combination of questionnaires and goal setting interview. Baseline testing of 3 goals.
- Treatment session + 2 surveys, approximately one hour long.
- Treatment session 3, approximately one hour long.
- Treatment session 4, approximately one hour long.
- Treatment session 5, approximately one hour long.
- Treatment session 6, approximately one hour long.
- Treatment session 7, approximately one hour long.
- Treatment session 8, approximately one hour long.
- Treatment session 9, approximately one hour long.
- Treatment session 10, followed by first post-intervention assessments, approximately 2 hours long.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups randomized to treatment (Post-ICU problem solving program) or usual care (no Post-ICU problem solving program).
| Arm | Type | Receives |
|---|---|---|
| Post-ICU Problem Solving | Experimental | Behavioral: Post-ICU Problem SolvingThe PIC-UPS intervention focuses on self-regulation activities and environmental cues to overcome problems with memory, planning and decision-making. The interventionist uses guided discovery, reviews progress, and emphasizes generalization and transfer to other patient-identified problems. This approach may be more acceptable to participants because they can see the relevance of tasks to everyday life. Activities such as goal-setting, self-evaluation and reflective thinking behaviors enhance self-efficacy and increase the likelihood that the individual will engage in self-management behaviors. The first session of PIC-UPS will be delivered after enrollment to those participants randomized to the intervention group. Weekly intervention sessions will be conducted by a trained interventionist and supplemented by telephone reminders to complete daily homework. Follow-up data collection will be conducted in the home by a blinded data collector three months post-enrollment. |
| Control Group | No intervention | –Participants in the control group will complete several surveys upon enrollment and randomization. Follow-up data collection will be conducted in the home for all participants control group by a blinded data collector three months post-enrollment. |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >55 years old
- discharged home following an ICU stay,
- reside at home and were functionally independent prior to admission to the ICU based on family report,
- speak and read English,
- mechanically ventilated for at least 48 hours,
Key exclusion criteria (5 listed)
- Pre-illness diagnosis of dementia or pre-morbid cognitive impairment (IQCODE score >3.51);
- profound uncorrected visual or hearing impairment that precludes use of the telephone;
- psychiatric condition that precludes full participation in the intervention;
- substance abuse as measured by cut-off score of 2 on CAGE-Substance Abuse Screening Tool;
- discharge to hospice care.
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 |
|---|---|---|
| Post-ICU Problem SolvingAlso: PIC-UPSWe have adapted the Cognitive Orientation to Daily Occupational Performance (CO-OP) as the Post-ICU Problem Solving intervention to be delivered in the home to patients following an illness that required an ICU stay. CO-OP is a form of meta-cognitive strategy training that teaches individuals to identify and prioritize problematic daily activities, identify barriers impeding performance, generate and evaluate strategies addressing these barriers, and generalize learning through practice. Thus, strategy training teaches skills that can be used to address disability in "real-life" activities, and is integral to personalized rehabilitation services. CO-OP has been adapted in numerous settings and most recently, it is being utilized successfully in patients with acquired cognitive dysfunction following acute stroke. This represents a useful intervention, tested in similar populations with minimal risk to the participants and potential for maximal benefit for this population. | Behavioural | Post-ICU Problem Solving |
Primary outcome
Change of Cognitive function as measured by Self-Administered Gerocognitive Examination
Time frame: Week 1 and week 12
Measure of the program's effect on Cognitive Function as measured using the Self-Administered Gerocognitive examination (SAGE) The maximum score is 22. A score of 17 and above is considered normal.
Change in development of Chronic Illness self management practices(as measured by Self-Efficacy Scale)
Time frame: Week 2 and Week 12
Determine the program's effect on Chronic Illness self- management as measured by the Self-Efficacy to Manage Chronic Disease Scale which is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).
Change in medication adherence practices (as measured by Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE))
Time frame: Week 2 and Week 12
Measure change in medication Adherence by using the MedMaIDE scale that contains a maximum total score of 13.
Change in participant's rate of depression as measured by Patient Health Questionnaire - 2)
Time frame: Week 1 and Week 12
Measure of the program's effect on rate of depression
Change in anxiety levels as measured by Geriatric Anxiety Scale (GAS)
Time frame: Week 1 and Week 12
Measure change in participant's anxiety levels as measured by Geriatric Anxiety Scale that contains 10 questions on anxiety with a scoring scale of 1-6 = Minimal; 7-9 = Mild, 10 = Moderate; 12-30 = Severe.
Change in depression levels as measured by Geriatric Depression Scale (GDS)
Time frame: Week 1 and Week 12
Measure change in participant's depression levels as measured by Geriatric Depression Scale that contains 15 questions on depression. A score of 5 or more suggests depression.
Change in Health related Quality of Life by a Short Form Health Survey - 36
Time frame: Week 1 and Week 12
Measures Health Related Quality of Life
Assess the effect of the Post-Intensive Care Problem Solving program through intervention completion rates
Time frame: 15 months
Assess the effect of the Post-intensive care program through intervention completion rates.
Access change in participant use of the health system
Time frame: Week 12
Access change in frequency of use of health system by use of the health system by number of times the study participatns use emergency department services, phone calls to physicians.
Assess change in functional independence when performing activities of daily living as measured by the Katz Activities of Daily Living Scale.
Time frame: Week 1 and Week 12
Measure change in participant's functional independence when performing activities of daily living using the Katz Activities of Daily Living Scale. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Assess change in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living.
Time frame: Week 1 and Week 12
Assess changes in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Judith A Tate, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-ICU Problem Solving in people with Critical Illness and Mechanical Ventilation Complication, run by Ohio State University 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 7 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: finished, as of the sponsor's last update on 25 Sep 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cognitive function as measured by Self-Administered Gerocognitive Examination (time frame: Week 1 and week 12). The study lists 11 primary outcomes in all. 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 25 Sep 2024.