Hospice
Conditions
Brief summary
With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME).
Detailed description
The study intervention focuses on assessing and addressing patient symptoms in the home hospice setting through weekly telehealth visits (for up to 6 weeks) and educational videos that are geared for the patient's informal caregiver. The aim of this phase of the project is two fold. One is that the study team will conduct a single armed (N=6 dyads) pilot study with a focus on optimizing data collection protocols and the intervention. After this step, a randomized pilot study evaluating the feasibility and potential efficacy of I-HoME (N=50 dyads) compared to usual care (N=50 dyads) will be conducted. Phase I of the study to assess feasibility of the intervention was registered on ClinicalTrials.gov as NCT04074304.
Interventions
BEHAVIORALI-HoME
I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos.
Sponsors
National Institute on Aging (NIA)
Visiting Nurse Service of New York
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
Home hospice caregivers must be: * English speaking * 18 years of age or older * not blind * having a family member receiving home hospice care Home hospice patients must be: * English speaking * 65 years of age or older * not blind * enrolled in home hospice care.
Exclusion criteria
* Patients with a terminal diagnosis of dementia or patients who have cognitive impairment and unable to sign a written informed consent will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits. | At the end of the intervention or at 6 weeks, which ever is earlier. | This measure is calculated by dividing the tele-visits conducted out of the total possible tele-visits. This measure shows the adherence of the I-HoME intervention arm to the tele-visits. |
| Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits. | At the end of the intervention or at 6 weeks, which ever is earlier. | The number of I-HoME intervention caregivers who reported at least one technical issues with the tele-visit. Participants in the intervention arm answered questions about whether they experienced technical issues. |
| Percentage of Tele-visits With Hardware Issues Out of the Total Number of Tele-visit Intervention Visits | At the end of the intervention or at 6 weeks, which ever is earlier. | After each intervention visit, participants answered questions about whether they experienced technical issues. This measure was calculated by dividing the number of I-HoME tele-visits during which the participant and/or the interventionist experienced hardware issues by the total number of I-HoME tele-visits administered during the entire study period. |
| Participant Recruitment Rate | During recruitment (22 months) | Recruitment rate was measured by the number of participants consented divided by the number of eligible participants. |
| Participant Attrition From Enrollment to End of Study | At the end of the intervention or at 6 weeks, which ever is earlier. | This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent. |
| Average Length of I-HoME Tele-visit | At the end of the intervention or at 6 weeks, which ever is earlier. | This measure was collected by calculating the average duration (in minutes) of each tele-visit between the participant in I-HoME intervention arm and the interventionalist. |
| Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants | At the end of the intervention or at 6 weeks, which ever is earlier. | This measure is the total number of videos watched by the I-HoME intervention arm participants who received at least one tele-visit. Intervention arm participants self-reported whether they watched the educational videos recommended to them by the interventionist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient Hospitalizations From Enrollment to End of Intervention | From enrollment to the end of the intervention or at 6 weeks, which ever is earlier. | All hospitalizations of the caregivers' patient from enrollment to end of intervention |
| Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | At baseline and weekly for 6 weeks. | Symptom burden score as measured by the Edmonton Symptom Assessment Scale (ESAS). Scale is from a 0 to 90, with higher scores indicating higher symptom burden. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Standard of care. | 40 |
| I-HoME Intervention Weekly televisits with a nurse practitioner that will implement the I-HoME intervention.
I-HoME: I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Control Arm | I-HoME Intervention |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 12.09 | 59.9 years STANDARD_DEVIATION 12.91 | 60.6 years STANDARD_DEVIATION 11.37 |
| Annual Household Income Range $25,000 or less | 11 Participants | 8 Participants | 3 Participants |
| Annual Household Income Range $25,001 to $50,000 | 22 Participants | 11 Participants | 11 Participants |
| Annual Household Income Range $50,001 to $75,000 | 18 Participants | 8 Participants | 10 Participants |
| Annual Household Income Range $75,001 or greater | 28 Participants | 13 Participants | 15 Participants |
| Annual Household Income Range Declined to answer | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 18 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 22 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest Education Completed College degree | 19 Participants | 10 Participants | 9 Participants |
| Highest Education Completed Graduate Degree | 26 Participants | 12 Participants | 14 Participants |
| Highest Education Completed High School or GED | 7 Participants | 4 Participants | 3 Participants |
| Highest Education Completed Post-graduate but no degree | 4 Participants | 2 Participants | 2 Participants |
| Highest Education Completed Some College | 21 Participants | 10 Participants | 11 Participants |
| Highest Education Completed Some high school | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 34 Participants | 17 Participants | 17 Participants |
| Region of Enrollment United States | 80 participants | 40 participants | 40 participants |
| Relationship to Patient Child | 54 Participants | 28 Participants | 26 Participants |
| Relationship to Patient Friend | 1 Participants | 1 Participants | 0 Participants |
| Relationship to Patient Relative | 11 Participants | 5 Participants | 6 Participants |
| Relationship to Patient Spouse/partner | 14 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Female | 63 Participants | 31 Participants | 32 Participants |
| Sex: Female, Male Male | 17 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Average Length of I-HoME Tele-visit
This measure was collected by calculating the average duration (in minutes) of each tele-visit between the participant in I-HoME intervention arm and the interventionalist.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
Population: The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-HoME Intervention | Average Length of I-HoME Tele-visit | 22.5 minutes | Standard Deviation 11.32 |
Primary
Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits.
The number of I-HoME intervention caregivers who reported at least one technical issues with the tele-visit. Participants in the intervention arm answered questions about whether they experienced technical issues.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
Population: The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits. | Reported Technical Issues | 0 Participants |
| All Participants | Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits. | Did Not Report Technical Issues | 0 Participants |
| I-HoME Intervention | Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits. | Reported Technical Issues | 13 Participants |
| I-HoME Intervention | Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits. | Did Not Report Technical Issues | 22 Participants |
Primary
Participant Attrition From Enrollment to End of Study
This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
Population: This measure includes all participants who were enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Participant Attrition From Enrollment to End of Study | 0 Participants |
| I-HoME Intervention | Participant Attrition From Enrollment to End of Study | 5 Participants |
Primary
Participant Recruitment Rate
Recruitment rate was measured by the number of participants consented divided by the number of eligible participants.
Time frame: During recruitment (22 months)
Population: All participants who we reached out to and were eligible for our study, including those who refused to participate, were unreachable over multiple attempts, and those who were initially interested in participating but not enrolled were included in the number of participants analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Participant Recruitment Rate | 37.7 percentage of enrolled participants |
Primary
Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits.
This measure is calculated by dividing the tele-visits conducted out of the total possible tele-visits. This measure shows the adherence of the I-HoME intervention arm to the tele-visits.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
Population: The total number of tele-visits completed by the I-HoME intervention arm participants was divided by the intended number of tele-visits for this group. The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I-HoME Intervention | Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits. | 89.6 percentage of tele-visits conducted out |
Primary
Percentage of Tele-visits With Hardware Issues Out of the Total Number of Tele-visit Intervention Visits
After each intervention visit, participants answered questions about whether they experienced technical issues. This measure was calculated by dividing the number of I-HoME tele-visits during which the participant and/or the interventionist experienced hardware issues by the total number of I-HoME tele-visits administered during the entire study period.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
Population: This measure was unable to be collected because it was difficult to distinguish hardware issues from other technical issues, which were reported in Primary Outcome #5.
Primary
Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants
This measure is the total number of videos watched by the I-HoME intervention arm participants who received at least one tele-visit. Intervention arm participants self-reported whether they watched the educational videos recommended to them by the interventionist.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
Population: The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I-HoME Intervention | Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants | 23 videos |
Secondary
Number of Patient Hospitalizations From Enrollment to End of Intervention
All hospitalizations of the caregivers' patient from enrollment to end of intervention
Time frame: From enrollment to the end of the intervention or at 6 weeks, which ever is earlier.
Population: This data was unable to be collected because we didn't have access to the patients' medical records after they were discharged to accurately determine whether they were hospitalized after hospice discharge.
Secondary
Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Symptom burden score as measured by the Edmonton Symptom Assessment Scale (ESAS). Scale is from a 0 to 90, with higher scores indicating higher symptom burden.
Time frame: At baseline and weekly for 6 weeks.
Population: This analysis included participants who completed the six-week study. The number of participants analyzed at each time point varied because:~1. Caregiver attrition~2. The caregiver did not answer one or more questions on the survey~3. The caregiver was ineligible to participate due to their care recipient passing away or being discharged from hospice~4. Caregivers in the intervention arm missed the tele-visit session on that particular week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 2 ESAS Score | 34.6 score on a scale | Standard Deviation 15.1 |
| All Participants | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 4 ESAS Score | 34.9 score on a scale | Standard Deviation 16.5 |
| All Participants | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 1 ESAS Score | 38.0 score on a scale | Standard Deviation 16.7 |
| All Participants | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 5 ESAS Score | 37.0 score on a scale | Standard Deviation 16.1 |
| All Participants | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 3 ESAS Score | 34.7 score on a scale | Standard Deviation 15.9 |
| All Participants | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 6 ESAS Score | 36.1 score on a scale | Standard Deviation 15.6 |
| All Participants | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Baseline ESAS Score | 39.0 score on a scale | Standard Deviation 13.9 |
| I-HoME Intervention | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 6 ESAS Score | 39.9 score on a scale | Standard Deviation 20.1 |
| I-HoME Intervention | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Baseline ESAS Score | 43.7 score on a scale | Standard Deviation 17.6 |
| I-HoME Intervention | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 1 ESAS Score | 40.7 score on a scale | Standard Deviation 19.6 |
| I-HoME Intervention | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 2 ESAS Score | 42.5 score on a scale | Standard Deviation 16.8 |
| I-HoME Intervention | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 3 ESAS Score | 42.3 score on a scale | Standard Deviation 16.1 |
| I-HoME Intervention | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 4 ESAS Score | 38.8 score on a scale | Standard Deviation 19.2 |
| I-HoME Intervention | Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks. | Week 5 ESAS Score | 44.1 score on a scale | Standard Deviation 17.9 |