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

Critical Illness Clinical Trial

— PIC-UPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972384
• Other study ID #: 2019H0089
• Status: Completed
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Critical Illness
• Delirium
• Mechanical Ventilation Complication

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University College of Nursing	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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