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

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Critical Illness; Cognitive Impairment; Mechanical Ventilation Complication
• Intervention / Treatment: Behavioral: Post-ICU Problem Solving

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Solove, MA; Phone Number: 614-247-8366; Email: solove.3@osu.edu
• Study Contact Backup: Name: JUDITH A TATE, PhD; Phone Number: 614-292-4907; Email: tate.230@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43231
      • The Ohio State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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	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.	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.	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	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.	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.	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.	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.	Week 1 and Week 12

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Judith A Tate, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Recovery; Problem Solving; Adaptation; Post-ICU Syndrome; Home Discharge
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Disease Attributes; Cognition Disorders; Cognitive Dysfunction; Critical Illness
• Other Study ID Numbers: 2019H0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No