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Conversational Agents to Improve Quality of Life in Palliative Care (ECA-PAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02750865
Recruitment Status : Enrolling by invitation
First Posted : April 26, 2016
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
Northeastern University
Boston University
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Michael Paasche-Orlow, Boston Medical Center

Brief Summary:

In this study the investigators will advance research on the development of easy to use technologies to empower patients. This is a scalable approach that has a significant potential to reduce suffering for palliative care patients and their caregivers. The investigators will adapt existing tested empathic conversational agents (ECA) for home-based cancer care management and inpatient bedside counseling to provide the following functions:

  1. medication counseling;
  2. physical activity promotion;
  3. symptom management and continual screening for adverse events; and
  4. alleviation of stress and anxiety
  5. spiritual needs assessment; and
  6. advanced care planning.

Data from the system will be monitored by a health professional, who communicates with members of the patient's care team. In this project, this activity will include facilitating referral for palliative care services.

The investigators will conduct pilot studies both at Boston Medical Center and at Northeastern University that will test system usability (Northeastern University and BMC) as well as interview burden (BMC only).

The investigators will conduct a Randomized Control Trial (RCT) to evaluate the agent technology, comparing usual care (UC) versus usual care plus the agent (UC+ECA) for patients 21 or older, with a life expectancy of < 1 year, from outpatient clinics at Boston Medical Center (BMC). Each subject will be enrolled along with a caregiver surrogate subject. In addition to baseline data collection, there will be monthly phone surveys for six months; intervention subjects will use the system for a six-month period of time. In addition, the investigators will conduct a randomized trial within the intervention group to compare subjects getting functions 1-4 (above) versus subjects getting the augmented intervention with all six functions. The intervention will include a nurse management interface to monitor clinical alerts generated by the system to stimulate interventions by the clinical staff.


Condition or disease Intervention/treatment Phase
Palliative Care Behavioral: Embodied Conversational Agent (ECA) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 823 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Conversational Agents to Improve Quality of Life in Palliative Care
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
No Intervention: Control Usual Care
In this arm the subject receives usual care and just completes the baseline interview, monthly telephone surveys about their quality of life, and the exit interview at 6 months after enrollment.
Experimental: Embodied Conversational Agent (ECA)
In this arm the subject is trained how to use a tablet device which they take home for the duration of the study. These subjects complete the baseline interview, monthly telephone surveys about their quality of life, and the exit interview at 6 months after enrollment.
Behavioral: Embodied Conversational Agent (ECA)
The ECA is a computer generated character who will interact with the subject on a daily basis via a touch-screen tablet. The system is designed to provide the following functions: (1) medication counseling; (2) physical activity promotion; (3) symptom management and continual screening for adverse events; and (4) alleviation of stress and anxiety. The investigators will augment the system to include: (5) spiritual needs assessment; and (6) advanced care planning.




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: assessed monthly up to 6 months ]
    QOL will be assessed using QLQ-C15-PAL, a 15-scale-item instrument designed to assess the quality of life of palliative cancer care patients.


Secondary Outcome Measures :
  1. Palliative Care services utilization [ Time Frame: assessed monthly up to 6 months ]
    Rate of receiving palliative care services as evidenced by presence of at least one Palliative Care clinical note in the EMR.

  2. Hospital utilization [ Time Frame: assessed at 6 months ]
    Data on healthcare utilization will be obtained through EMR review and monthly phone survey of all subjects for six months, or until patient death. The investigators will obtain data on the number of urgent care, emergency room, hospital observation visits, and hospital admissions.

  3. Cost [ Time Frame: assessed at 6 months ]
    Costs will be obtained from the actual observed costs from the annual Medical Expenditure Panel Surveys (MEPS) conducted the Agency for Healthcare Research and Quality (AHRQ), specific to each service type (ED, inpatient stay and outpatient visit) and reason for visit (principal diagnosis). We will also adjust for inflation in costs over time. The primary utilization measure will be the total costs for all ED visits, inpatient stays, and outpatient physician visits. As secondary measures the investigators will examine the cost of different services. As a simple budget impact assessment the investigators will also evaluate the cost of the intervention, specifically, the provision of additional nurse management services.

  4. Mental health [ Time Frame: assessed at enrollment and at 6 months ]
    Mental and Social health will be assessed using the PROMIS Mental Health (including subscales on: depression, anxiety, anger, cognitive function, alcohol use, consequences, and expectancies, psychosocial illness impact, self-efficacy, and smoking,) and PROMIS Social Health (including subscales on: ability to participate in social roles and activities, satisfaction with social roles and activities, social support, social isolation, and companionship) instruments. The NIH PROMIS measures have been subjected to extensive reliability and validity testing.

  5. Patient activation [ Time Frame: assessed at enrollment and at 6 months ]
    Patient Activation will be measured using the Patient Activation Measure (PAM).

  6. Medication adherence [ Time Frame: assessed at enrollment and at 6 months ]
    Medication Adherence will be assessed using the Patient Medication Adherence Questionnaire (PMAQ).

  7. Symptoms [ Time Frame: assessed at enrollment and at 6 months ]
    Symptoms will be assessed using the Edmonton Symptom Assessment Scale-revised (ESAS-r).

  8. Spiritual Needs [ Time Frame: assessed at enrollment and at 6 months ]
    Spiritual Needs will be assessed using the Spiritual Needs Assessment for Patients instrument (SNAP). SNAP includes 23 items in three domains: psychosocial (n=5), spiritual (n=13), and religious (n=5).

  9. Medical Orders for Life-Sustaining Treatment (MOLST) completion rate [ Time Frame: assessed at enrollment and at 6 months ]
    MOLST form completion rate as identified in the Electronic Medical Record

  10. Advance Care Planning and preferences [ Time Frame: assessed at enrollment and at 6 months ]
    ACP communication and preferences will be assessed using a survey that the investigators have used in prior work.

  11. Physical activity [ Time Frame: assessed at enrollment and at 6 months ]
    Physical activity will be assessed using the walking items from the validated CHAMPS questionnaire for older adults. The CHAMPS assesses usual weekly amounts of walking over the previous 4 weeks in minutes per week, and these items have been significantly associated with pedometer steps and were sensitive to change with a prior ECA-based walking promotion intervention for older adults.

  12. Use of the ECA-PAL system by subjects in the intervention group [ Time Frame: assessed at 6 months ]
    Use of the ECA-PAL system will be determined from log files stored in the database, describing the details of all sessions with the patients, including all discussion topics and questions asked.

  13. Satisfaction with the ECA-PAL system [ Time Frame: assessed at 6 months ]
    Satisfaction with the ECA-PAL system will be assessed using attitudinal measures that have been used in the investigators' prior work. These include the 19-item computer program acceptability scale, and the 12-item bonding subscale of the Working Alliance Inventory (WAI).

  14. Social health [ Time Frame: assessed at enrollment and at 6 months ]
    Social health will be assessed using the PROMIS Social Health (including subscales on: ability to participate in social roles and activities, satisfaction with social roles and activities, social support, social isolation, and companionship) instruments.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 21 years of age or older
  2. English speaking
  3. Able to independently consent to be in the study
  4. Has adequate corrected vision to be able to use the ECA system (based on a 1-minute ECA functional screener)
  5. Has adequate hearing to be able to use the ECA system (headphones will be available)
  6. Has a health care provider who endorses the existence of a potentially life-limiting condition and endorses that it would not be a surprise if the patient died within 12 months (PATIENT-SUBJECTS only)

Exclusion Criteria:

  1. Enrolled in hospice
  2. Already being followed by the Palliative Care team
  3. Suicidal or homicidal
  4. In police custody
  5. Do not live in the Boston area
  6. Plan on leaving the Boston area for more than 4 weeks in the next 6 months
  7. Not able to use the ECA tablet computer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750865


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Northeastern University
Boston University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Michael Paasche-Orlow, MD, MPH Boston Medical Center

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Responsible Party: Michael Paasche-Orlow, Associate Professor, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02750865     History of Changes
Other Study ID Numbers: H-34877
1R01NR016131 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Paasche-Orlow, Boston Medical Center:
biomedical technology
palliative care