Clinical trial NCT04543201: Telehealth Visits to Discuss Advanced Directives for Patients Newly Diagnosed With High Grade Glioma
Official title: Early Telehealth Visits for Discussion of Advanced Directives for Patients Newly Diagnosed With High Grade Glioma: Impact on Patient Care and Satisfaction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. It is important for patients with HGG to discuss and document their wishes at the end of life. However, many of these patients experience early changes in cognition which impede their decision-making. For this reason, these patients should have early discussions with their providers. However, implementation of this remains challenging in clinical practice.

In this study, we will create an Early STructured Advanced care Referrals by Telehealth (Early START) visit for patients soon after their initial oncology visit. A checklist and pre-visit guide were developed to help guide the visit for both the provider and patient. Providers will receive special training in running these visits. Caregivers and/or family members will be encouraged to participate. Visits will be done using video or telephone and recorded. For patients who do not have access to technology for these visits, it will be provided. After the visit, patients, caregivers and/or family who participated, and providers will fill out surveys to address feasibility of having these extra visits and improve the visits for future. Patients will be followed until death. Caregivers and/or family who participated will be asked about whether end of life was in line with the patient's wishes. We will also use the patient's medical record to assess other aspects of end of life. We will compare end of life outcomes with other similar patients treated at our center.

Detailed description: High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. Discussion and documentation of an advance care plan are needed to achieve end of life goals that are concordant with a patient's wishes. Early cognitive dysfunction in brain tumor patients can impede patients from making decisions about their own care. Patients with HGG, therefore require discussion and documentation of end of life goals early in their disease course, but implementation of this has been elusive.

In this study, we will integrate an Early STructured Advanced care Referrals by Telehealth (Early START) visit into standard neuro-oncologic care prior to initiation of adjuvant chemotherapy in patients with HGG. Multi-disciplinary providers including physicians, advanced practice providers, and nurses will undergo an in-service by palliative care experts to perform Early START with a standardized checklist followed by periodic training sessions. Fifty patients with HGG will be enrolled over a 12-month period. They will receive a pre-visit educational guide to increase literacy regarding advance directives (AD) followed by a provider-led Early START visit that will be recorded. Post-visit assessments will address patient and caregiver perspectives on the intervention, patient and caregiver knowledge, patient satisfaction and patient-reported anxiety measures. A provider questionnaire will assess length of visit, adherence to the checklist and AD outcomes of the visit. Patients will be followed until death. End of life quality measures and concordance of death with goals of care will be assessed using a combination of caregiver surveys and the electronic medical record. These outcomes will be compared to historical controls treated at our center from 2010-2015.

Specific Aims:

Aim 1a. To determine the effectiveness of Early START as measured by AD documentation.

Aim 1b. To determine the utility of Early START as measured by timing of hospice enrollment at the end of life and place of death concordant with the patient's goals.

Hypothesis: As our primary aim, we hypothesize that Early START will increase the percentage of AD documentation by the 3rd oncology visit from 51% to 80%. As secondary outcomes, we hypothesize that it will decrease the percentage of AD that are completed by proxy from 45% to 25%, will improve end of life quality measures as compared to our published historical controls and that the majority of patients who undergo Early START will die in a setting of their choosing.

Aim 2a. To demonstrate the feasibility of Early START as measured by the percent of visits completed prior to the third oncology visit, adherence to a pre-specified checklist, and length of time to complete the visit.

Aim 2b. To optimize the Early START intervention by incorporating patient/caregiver and provider feedback.

Hypothesis: We hypothesize that 80% of visits will be completed using telehealth by the 3rd oncology visit, 80% of providers will utilize the pre-specified checklist and that average visit duration will be less than one hour.

Eligibility criteria: Inclusion Criteria:

* New pathologic diagnosis of WHO grade III or IV glioma within four months of consent
* English speaking

Exclusion Criteria:

* Severe cognitive dysfunction or aphasia precluding discussion of advanced care planning issues

Primary outcomes:
measure: Advanced Directive Completion Rate
timeFrame: Time of diagnosis to 3rd oncology visit at an average of 4 months
Secondary outcomes:
measure: Early START visit completion
timeFrame: Time of diagnosis to 3rd oncology visit at an average of 4 months
measure: Checklist use
timeFrame: Time of Early START visit [on average between 3-4 months after diagnosis]
measure: Duration of visit
timeFrame: Duration of visit [average 60 min]
measure: Advanced Care Directive Completion by patient vs proxy
timeFrame: Time of diagnosis to death up to 5 years after registration
measure: Chemotherapy use at end of life
timeFrame: Time of diagnosis to death up to 5 years after registration
measure: Hospice enrollment
timeFrame: Time of diagnosis to death up to 5 years after registration
measure: Palliative care and/or hospice involvement at end of life
timeFrame: Time of diagnosis to death up to 5 years after registration
measure: Setting of end of life
timeFrame: Time of diagnosis to death up to 5 years after registration
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Sara Hardy, MD
role: PRINCIPAL_INVESTIGATOR
References: