Improving Needs Among Older Adults

Launched by DUKE UNIVERSITY · Sep 6, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Improving Needs Among Older Adults," is looking to improve the care and support provided to older adults who are critically ill and receiving treatment in intensive care units (ICUs). The researchers have created a mobile app called ICUconnect to help patients and their families express their needs for palliative care, which is specialized support focused on providing relief from symptoms and improving the quality of life. The trial will compare the use of the ICUconnect app with standard care for about 350 patients and their family members at four different hospitals. The goal is to see if using the app leads to better support for patients and reduces feelings of distress.

To participate in the trial, patients must be at least 60 years old, have been in the ICU for at least 48 hours due to serious health issues (like needing help to breathe), and be expected to stay in the ICU for at least three more days. Family members providing support must be at least 18 years old and have a close relationship with the patient. Participants can expect to engage with the app and healthcare team to ensure their needs are met. This trial is a unique opportunity to help improve care for older adults in ICUs and make sure families feel supported during a challenging time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients (who are not interviewed but whose characteristics prompt enrollment of family members)
• • 1. Older adult aged ≥60 years
• • 2. Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU for ≥48 hours
• 3. Serious acute cardiorespiratory condition, defined as ≥1 of the following:
• • mechanical ventilation via endotracheal tube for ≥48 hours continuously
• • non-invasive ventilation (CPAP, BiPAP) for ≥48 hours (breaks of up to 4 hours within each 12-hour period acceptable)\*
• • high flow supplemental oxygen for ≥48 hours continuously\*
• • use of vasopressors or inotropes for shock of any etiology for ≥48 hours continuously \*note that non-invasive ventilation plus high flow supplemental oxygen together totaling ≥48 hours is also acceptable
• • 4. ICU team expect patient to require ICU care for ≥3 more days
• • Family members
• • 1. Adult aged ≥18 years
• • 2. Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of family; Davidson J, et al. Crit Care Med, 45:103-128; 2017)
• • ICU clinicians
• • 1. Adult aged ≥18 years
• • 2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent
• Exclusion Criteria:
• • Patients\*
• • 1. Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely
• • 2. Palliative care consultative team and/or palliative care specialists have followed the patient during the hospitalization.
• • Rationale: this would dilute the intervention's effect.
• • 3. ICU length of stay \>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization.
• • 4. ICU length of stay \>7 days at an outside hospital's ICU before transfer to a study hospital ICU.
• • Rationale: this scenario would represent an atypical outlier case of unique complexity.
• • 5. Hospital length of stay \>10 days at outside hospital (either on ward or ward plus ICU) before transfer to study hospital.
• • Rationale: this scenario would represent an atypical outlier case of unique complexity.
• • 6. Imprisoned person Rationale: this is a vulnerable population.
• • Note that decisional capacity is not an exclusion, as described in the Research Strategy. However, it is anticipated 75-80% of patients will lack decisional capacity due to their critical illness, delirium, and other factors based on our past work with similar eligibility criteria.
• • Family members
• • 1. Low palliative care need burden (i.e., NEST scale score ≤15) at baseline (i.e., T1 data collection).
• • Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST). Furthermore, specialist consultation could misdirect care from those with higher perceived needs in times of institutional staffing stresses. In past work, 15-25% of pilot participants had a NEST ≤15, and all had low levels of distress (see Research Strategy and Recruitment and Retention Plan).
• • 2. Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions.
• • Rationale: the app has not been translated into other languages; also, many outcome measures aren't validated in languages other than English and Spanish.
• • 3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of T1 data collection.
• • Rationale: this indicates a serious level of distress that will require professional assistance beyond that provided by the intervention (or control).
• • 4. Patient regains decisional capacity after informed consent but before the family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would substantially change the nature of the interactions of family members and clinicians.
• • ICU clinicians None