DementiaNCT06374992
Family Involvement Hospital Ethnography
An observational study of Dementia, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 13 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Aim 1 will comprise a population of adults with cognitive impairment hospitalized in the Duke University Health System (DUHS), their family caregiver, and health care workers on their care team. Aim 2 will comprise health system leaders within DUHS.
Who may be able to join
- Having a documented diagnosis of dementia or cognitive impairment
- Slated for admission to the hospital or admitted to the hospital
- Able to speak about the topics in the interview in English
- Capable of providing consent OR legally authorized representative (LAR) consents to patient's participation in study
- Exclusion criteria for patient participants: Incapable of providing consent AND LAR unable to be reached or does not consent
- Age 18 or older
Show all 18Show fewer
- Able to speak about the topics in the interview in English
- Is accompanying the patient slated for admission to the hospital or admitted to the hospital when the patient is approached, is the person the patient identifies as being the family member most involved in their hospital care, or is the emergency contact person for the patient listed in the medical record
- Willing to participate
- Age >18
- Employed by Duke University Health System
- Physician, advanced practice provider (APP), or nurse on the care team of the patient with cognitive impairment
- Able to provide informed consent
- Willing to participate
- Exclusion criteria for health care worker participants: Other profession (non-physician, APP, or nurse) on care team of the patient
- AIM 2:
- Inclusion criteria: Hospital executives, department chairs, division chiefs, nurse managers, medical directors, and other health system leaders.
- Exclusion criteria: Does not have leadership role within the health system.
Who cannot join
- Incapable of providing informed consent
- Accompanying patient as a paid caregiver or aide
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Regional Hospital
Durham, North Carolina, 27704
About this study
Official title: A Hospital Ethnography of Family Involvement in the Care of Hospitalized Older Adults With Cognitive Impairment
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:
- What features of the healthcare system facilitate or hinder family involvement in care from the perspective of patients, families, and healthcare workers?
- 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.
Read the detailed 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.
- Conditions
- Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Hospitalized older adults with cognitive impairment/dementia | |
| Family | Family member, friend, or neighbor involved in a hospitalization of an older adult motivated by a personal relationship rather than financial remuneration | |
| Healthcare Worker | Physicians, APPs, or nurses involved in the care of the patient with cognitive impairment/dementia | |
| Health system leader | Hospital executives, department chairs, division chiefs, nurse managers, medical directors, and other leaders within the health system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facilitators and Barriers to Family Involvement in Care of Hospitalized Older Adults with Cognitive Impairment
Assessed via interviews and observation of patient/family dyad throughout hospitalization and possible healthcare professionals on care team
Measured: Entry interview within 24 hours of admission through exit interview within 72 hours of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start2 May 2024
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Vick, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374992
- Sponsor's protocol ID
- Pro00114569
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hospital Ethnography of Family Involvement in the Care of Hospitalized Older Adults With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06374992
- Acronym / sponsor ID
- Pro00114569
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What features of the healthcare system facilitate or hinder family involvement in care from the perspective of patients, families, and healthcare workers?
- 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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Hospitalized older adults with cognitive impairment/dementia |
| Family | – | –Family member, friend, or neighbor involved in a hospitalization of an older adult motivated by a personal relationship rather than financial remuneration |
| Healthcare Worker | – | –Physicians, APPs, or nurses involved in the care of the patient with cognitive impairment/dementia |
| Health system leader | – | –Hospital executives, department chairs, division chiefs, nurse managers, medical directors, and other leaders within the health system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Aim 1 will comprise a population of adults with cognitive impairment hospitalized in the Duke University Health System (DUHS), their family caregiver, and health care workers on their care team. Aim 2 will comprise health system leaders within DUHS.
Key inclusion criteria (18 listed)
- Having a documented diagnosis of dementia or cognitive impairment
- Slated for admission to the hospital or admitted to the hospital
- Able to speak about the topics in the interview in English
- Capable of providing consent OR legally authorized representative (LAR) consents to patient's participation in study
- Exclusion criteria for patient participants: Incapable of providing consent AND LAR unable to be reached or does not consent
Key exclusion criteria (2 listed)
- Incapable of providing informed consent
- Accompanying patient as a paid caregiver or aide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Facilitators and Barriers to Family Involvement in Care of Hospitalized Older Adults with Cognitive Impairment
Time frame: Entry interview within 24 hours of admission through exit interview within 72 hours of discharge
Assessed via interviews and observation of patient/family dyad throughout hospitalization and possible healthcare professionals on care team
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Vick, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facilitators and Barriers to Family Involvement in Care of Hospitalized Older Adults with Cognitive Impairment (time frame: Entry interview within 24 hours of admission through exit interview within 72 hours of discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.