A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults
- Conditions
- Mechanical Ventilation ComplicationDeliriumCognitive ImpairmentCritical Illness
- Interventions
- Behavioral: Post-ICU Problem Solving
- Registration Number
- NCT03972384
- Lead Sponsor
- Ohio State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- >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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Post-ICU Problem Solving 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.
- Primary Outcome Measures
Name Time Method Change in development of Chronic Illness self management practices(as measured by Self-Efficacy Scale) Week 2 and Week 12 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 of Cognitive function as measured by Self-Administered Gerocognitive Examination Week 1 and week 12 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 anxiety levels as measured by Geriatric Anxiety Scale (GAS) Week 1 and Week 12 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) Week 1 and Week 12 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 Week 1 and Week 12 Measures Health Related Quality of Life
Change in participant's rate of depression as measured by Patient Health Questionnaire - 2) Week 1 and Week 12 Measure of the program's effect on rate of depression
Assess change in functional independence when performing instrumental activities of daily living using the Lawton Instrumental Activities of Daily Living. Week 1 and Week 12 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.Change in medication adherence practices (as measured by Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE)) Week 2 and Week 12 Measure change in medication Adherence by using the MedMaIDE scale that contains a maximum total score of 13.
Access change in participant use of the health system Week 12 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 the effect of the Post-Intensive Care Problem Solving program through intervention completion rates 15 months Assess the effect of the Post-intensive care program through intervention completion rates.
Assess change in functional independence when performing activities of daily living as measured by the Katz Activities of Daily Living Scale. Week 1 and Week 12 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ohio State University College of Nursing
🇺🇸Columbus, Ohio, United States