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A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults (PIC-UPS)

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. Identifier: NCT03972384
Recruitment Status : Not yet recruiting
First Posted : June 3, 2019
Last Update Posted : June 20, 2019
Information provided by (Responsible Party):
Judith Tate, Ohio State University

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Illness Mechanical Ventilation Complication Delirium Cognitive Impairment Behavioral: Post-ICU Problem Solving Not Applicable

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

  1. Assessment session approximately one and a half hours long. Combination of questionnaires and goal setting interview. Baseline testing of 3 goals.
  2. Treatment session + 2 surveys, approximately one hour long.
  3. Treatment session 3, approximately one hour long.
  4. Treatment session 4, approximately one hour long.
  5. Treatment session 5, approximately one hour long.
  6. Treatment session 6, approximately one hour long.
  7. Treatment session 7, approximately one hour long.
  8. Treatment session 8, approximately one hour long.
  9. Treatment session 9, approximately one hour long.
  10. Treatment session 10, followed by first post-intervention assessments, approximately 2 hours long.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups randomized to treatment (Post-ICU problem solving program) or usual care (no Post-ICU problem solving program).
Masking: Single (Outcomes Assessor)
Masking Description: Data collectors are blind to condition.
Primary Purpose: Supportive Care
Official Title: A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Experimental: Post-ICU Problem Solving
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.
Behavioral: Post-ICU Problem Solving
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.
Other Name: PIC-UPS

No Intervention: Control Group
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.

Primary Outcome Measures :
  1. Change of Cognitive function as measured by Montreal Cognitive Assessment [ Time Frame: Week 1 and week 12 ]
    Measure of the program's effect on Cognitive Function as measured using the Montreal Cognitive assessment (MoCA) with a score range between 0 and 30. A score of 26 or over is considered to be normal.

  2. 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).

  3. Change in medication adherence practices (as measured by Morisky Self-Adherence Scale) [ Time Frame: Week 2 and Week 12 ]

    Measure change in medication Adherence by using the Morisky scale that contains 4 Yes, No questions. with Yes=0 and No=1

    • Zero is the lowest level of medication adherence
    • 4 is the highest level of medication adherence

  4. 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

  5. Change in Cognitive function as measured by Modified Mini Mental Status Exam [ Time Frame: Week 1 and Week 12 ]
    Measure change in Cognitive Function as measured by Modified Mini Mental Status Exam (MMSE) that has a score range of 1-100 with 1 being low and 100 the highest score.

  6. Change in anxiety levels as measured by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Week 1 and Week 12 ]
    Measure change in participant's anxiety levels as measured by Hospital Anxiety and Depression Scale that contains 7 questions on Depression and 7 questions on anxiety with a scoring scale of 0 - 21. 0-7 = Normal; 8 - 10 = bordeline case; 11-21 = Case.

  7. 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

  8. 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.

  9. Access change in participant use of the health system [ Time Frame: Week 12 ]
    Access change in frequency of use of emergency department services of study participants.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03972384

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Contact: JUDITH A TATE, PhD 614-292-4907

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United States, Ohio
The Ohio State University College of Nursing Recruiting
Columbus, Ohio, United States, 43231
Contact: Grace K Njoroge, MS    614-688-2530   
Sponsors and Collaborators
Ohio State University
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Principal Investigator: Judith A Tate, PhD Ohio State University

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Responsible Party: Judith Tate, Principal Investigator, Ohio State University Identifier: NCT03972384     History of Changes
Other Study ID Numbers: 2019H0089
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Judith Tate, Ohio State University:
Post-ICU Syndrome
Home Discharge
Problem Solving
Additional relevant MeSH terms:
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Critical Illness
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes