Clinical trial NCT03972384: A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
Official title: A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Mechanical Ventilation Complication
Delirium
Cognitive Impairment
Keywords: Post-ICU Syndrome
Recovery
Home Discharge
Problem Solving
Adaptation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 19
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups randomized to treatment (Post-ICU problem solving program) or usual care (no Post-ICU problem solving program).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change of Cognitive function as measured by Self-Administered Gerocognitive Examination
timeFrame: Week 1 and week 12
measure: Change in development of Chronic Illness self management practices(as measured by Self-Efficacy Scale)
timeFrame: Week 2 and Week 12
measure: Change in medication adherence practices (as measured by Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE))
timeFrame: Week 2 and Week 12
measure: Change in participant's rate of depression as measured by Patient Health Questionnaire - 2)
timeFrame: Week 1 and Week 12
measure: Change in anxiety levels as measured by Geriatric Anxiety Scale (GAS)
timeFrame: Week 1 and Week 12
measure: Change in depression levels as measured by Geriatric Depression Scale (GDS)
timeFrame: Week 1 and Week 12
measure: Change in Health related Quality of Life by a Short Form Health Survey - 36
timeFrame: Week 1 and Week 12
measure: Assess the effect of the Post-Intensive Care Problem Solving program through intervention completion rates
timeFrame: 15 months
measure: Access change in participant use of the health system
timeFrame: Week 12
measure: Assess change in functional independence when performing activities of daily living as measured by the Katz Activities of Daily Living Scale.
timeFrame: Week 1 and Week 12
measure: Assess change in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living.
timeFrame: Week 1 and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
affiliation: Ohio State University
name: Judith A Tate, PhD
role: PRINCIPAL_INVESTIGATOR
References: