Telehealth Visits to Discuss Advanced Directives for Patients Newly Diagnosed With High Grade Glioma

January 9, 2024 updated by: Sara J Hardy, University of Rochester

Early Telehealth Visits for Discussion of Advanced Directives for Patients Newly Diagnosed With High Grade Glioma: Impact on Patient Care and Satisfaction

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early STructured Advanced care Referrals by Telehealth

Early START visit using checklist over telephone or zoom:

A telehealth visit conducted within 4 months of patient diagnosis, with the goal of encouraging patients to discuss and document their end-of-life wishes prior to the onset of cognitive impediments common among patients with late-stage high grade glioma.

Prior to visit subject receives pre-visit educational guide and copy of advance directive form

Follow up surveys:

Immediate: provider feedback survey

2-4 weeks after visit: subject feedback survey and caregiver/family feedback survey

After subject death: caregiver/family survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced Directive Completion Rate
Time Frame: Time of diagnosis to 3rd oncology visit at an average of 4 months
Percentage of patients who complete an advanced directive by the third oncology visit
Time of diagnosis to 3rd oncology visit at an average of 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early START visit completion
Time Frame: Time of diagnosis to 3rd oncology visit at an average of 4 months
Percentage of Early START (Early STructured Advanced care Referrals by Telehealth) visits completed by the third oncology visit
Time of diagnosis to 3rd oncology visit at an average of 4 months
Checklist use
Time Frame: Time of Early START visit [on average between 3-4 months after diagnosis]
Percentage of providers who use the checklist
Time of Early START visit [on average between 3-4 months after diagnosis]
Duration of visit
Time Frame: Duration of visit [average 60 min]
Duration of time in minutes
Duration of visit [average 60 min]
Advanced Care Directive Completion by patient vs proxy
Time Frame: Time of diagnosis to death up to 5 years after registration
Percentage of completed Advanced Care Directives completed by proxy (rather than by the patient)
Time of diagnosis to death up to 5 years after registration
Chemotherapy use at end of life
Time Frame: Time of diagnosis to death up to 5 years after registration
Percentage of patients that were treated with chemotherapy within 14 days of death
Time of diagnosis to death up to 5 years after registration
Hospice enrollment
Time Frame: Time of diagnosis to death up to 5 years after registration
Percentage of patients who were enrolled in hospice >7 days prior to death
Time of diagnosis to death up to 5 years after registration
Palliative care and/or hospice involvement at end of life
Time Frame: Time of diagnosis to death up to 5 years after registration
Percentage of patients who received a palliative care or hospice consult prior to death
Time of diagnosis to death up to 5 years after registration
Setting of end of life
Time Frame: Time of diagnosis to death up to 5 years after registration
Percentage of patients for whom setting of death was consistent with their wishes
Time of diagnosis to death up to 5 years after registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sara Hardy, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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