Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06374992 |
| Other study ID # |
Pro00114569 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Duke University |
| Contact |
Judith Vick |
| Phone |
919-970-9469 |
| Email |
judith.vick[@]duke.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is to learn about the role of family members in caring
for hospitalized older adults with cognitive impairment. The main questions it aims to answer
are:
1. What features of the healthcare system facilitate or hinder family involvement in care
from the perspective of patients, families, and healthcare workers?
2. How do hospital leaders understand the facilitators and barriers to family involvement?
Data collection will occur via semi-structure interviews, direct observation, and artifact
analysis.
Description:
The investigators will use three complementary ethnographic approaches to achieve the study
aims: direct observation (Aim 1); interviews with key informants (Aims 1 and 2); and analysis
of artifacts such as policy documents related to visitation, care of cognitively impaired
older adults, and family-centered care in the hospital (Aim 2).
AIM 1: To identify facilitators and barriers to family member involvement in the care of
hospitalized older adults with cognitive impairment using in-context, semi-structured
interviews and unobtrusive direct observation of patients, families, and healthcare workers.
The investigators will employ participant observation and semi-structured interviews for each
enrolled patient-family member dyad. For each dyad, the investigators will conduct two
interviews, each lasting approximately 30-60 minutes. One interview will occur within 24
hours of admission ("entry interview") and one within 72 hours of discharge ("exit
interview"). Both interviews will address how the participant (patient if able to contribute,
and family member) perceive the family member in relation to the healthcare team and their
experiences of involvement in care. Each dyadic patient/family interview will be conducted by
the Principal Investigator or her delegate and digitally recorded, with the consent of
participants, for subsequent transcription and analysis. In addition, three periods of direct
observation will occur. Direct observations will focus on interactions between hospital
staff, patients, and families, and what family members do during a patient's hospital stay.
Observations will be recorded as field notes. Finally, the investigators will interview one
to three healthcare workers (physicians, advanced practice providers, nurses) involved in the
patient's care for each enrolled patient-family dyad. Healthcare worker interviews will take
place either during the patient's hospitalization or within a week of the patient's discharge
and may take place in person or remotely (phone or videoconference). Demographic and baseline
data from the patient, family member, and healthcare workers that may affect family
involvement will also be collected.
AIM 2: To understand hospital leadership perspectives on barriers to integration of family
members into care for hospitalized older adult patients with cognitive impairment. For this
aim, the investigators will conduct one-on-one interviews hospital leadership. After consent
is obtained, study staff will conduct each interview using a semi-structured interview guide
which queries topics on system-level facilitators and barriers to family involvement in the
care of hospitalized older adults with cognitive impairment (e.g., visiting hour policies,
rounding schedules). Aim 2 will also include an artifact analysis of policy documents related
to visitation, care of cognitively impaired older adults, and family-centered care in the
hospital.
