A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults

NCT ID: NCT03972384

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2023-03-01

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.

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.

Conditions

Critical Illness; Mechanical Ventilation Complication; Delirium; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Post-ICU Problem Solving

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PIC-UPS

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Judith Tate

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith A Tate, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University College of Nursing

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2019H0089

Identifier Type: -

Identifier Source: org_study_id