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

Primary Purpose

Critical Illness, Mechanical Ventilation Complication, Delirium

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Post-ICU Problem Solving
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Post-ICU Syndrome, Recovery, Home Discharge, Problem Solving, Adaptation

Eligibility Criteria

55 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University College of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Post-ICU Problem Solving

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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.
Change in participant's rate of depression as measured by Patient Health Questionnaire - 2)
Measure of the program's effect on rate of depression
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.
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.
Change in Health related Quality of Life by a Short Form Health Survey - 36
Measures Health Related Quality of Life
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2019
Last Updated
October 4, 2022
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03972384
Brief Title
A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
Acronym
PIC-UPS
Official Title
A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Mechanical Ventilation Complication, Delirium, Cognitive Impairment
Keywords
Post-ICU Syndrome, Recovery, Home Discharge, Problem Solving, Adaptation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups randomized to treatment (Post-ICU problem solving program) or usual care (no Post-ICU problem solving program).
Masking
Outcomes Assessor
Masking Description
Data collectors are blind to condition.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-ICU Problem Solving
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Post-ICU Problem Solving
Other Intervention Name(s)
PIC-UPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Cognitive function as measured by Self-Administered Gerocognitive Examination
Description
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.
Time Frame
Week 1 and week 12
Title
Change in development of Chronic Illness self management practices(as measured by Self-Efficacy Scale)
Description
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).
Time Frame
Week 2 and Week 12
Title
Change in medication adherence practices (as measured by Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE))
Description
Measure change in medication Adherence by using the MedMaIDE scale that contains a maximum total score of 13.
Time Frame
Week 2 and Week 12
Title
Change in participant's rate of depression as measured by Patient Health Questionnaire - 2)
Description
Measure of the program's effect on rate of depression
Time Frame
Week 1 and Week 12
Title
Change in anxiety levels as measured by Geriatric Anxiety Scale (GAS)
Description
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.
Time Frame
Week 1 and Week 12
Title
Change in depression levels as measured by Geriatric Depression Scale (GDS)
Description
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.
Time Frame
Week 1 and Week 12
Title
Change in Health related Quality of Life by a Short Form Health Survey - 36
Description
Measures Health Related Quality of Life
Time Frame
Week 1 and Week 12
Title
Assess the effect of the Post-Intensive Care Problem Solving program through intervention completion rates
Description
Assess the effect of the Post-intensive care program through intervention completion rates.
Time Frame
15 months
Title
Access change in participant use of the health system
Description
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.
Time Frame
Week 12
Title
Assess change in functional independence when performing activities of daily living as measured by the Katz Activities of Daily Living Scale.
Description
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.
Time Frame
Week 1 and Week 12
Title
Assess change in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living.
Description
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.
Time Frame
Week 1 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JUDITH A TATE, PhD
Phone
614-292-4907
Email
tate.230@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Solove, MA
Phone
614-247-8366
Email
solove.3@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith A Tate, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Nursing
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace K Njoroge, MS
Phone
614-688-2530
Email
gkmbogo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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