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Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study (TPC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Diane Holland, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01934413
First received: August 29, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The purpose of this pilot study is to develop and test a technology-enhanced transitional palliative care (TPC) intervention for patients and caregivers living in rural locations. The investigators hypothesize that access to palliative care will be improved, thereby improving patient and caregiver reported outcomes and decreasing the use of costly health services.


Condition Intervention
Palliative Care
Transitional Care
Behavioral: Technology-Enhanced Transitional Palliative Care
Other: Usual Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in mean scores on FACIT-Pal Questionnaire [ Time Frame: Baseline, 1 month post-enrollment, 2 months post-enrollment ] [ Designated as safety issue: No ]
    The patient's quality of life will be determined by the change in mean scores from baseline to 1 month and 2 months post enrollment, using the Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal). The FACIT-Pal palliative subscale contains 19 questions specific to persons with life-limiting illness. Each item is rated on a 5 point numeric rating scale from 9 (not at all) to 4 (very much). Scores range from 0-76. Higher scores indicate better quality of life.


Secondary Outcome Measures:
  • Change in mean scores on ESAS-r Questionnaire [ Time Frame: Baseline, 1 month post-enrollment, 2 months post-enrollment ] [ Designated as safety issue: No ]
    The patient's symptom intensity will be determined by the change in mean scores from baseline to 1 month and 2 months post enrollment, as measured by the Edmonton Symptom Assessment System (revised) ESAS-r scale, The ESAS-r captures the patient's perspective on 9 symptoms that are common in palliative care (pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, wellbeing). An optional 10th symptom can be reported. Each symptom is rated on an 11 point numeric rating scale from 0 (symptom absent or best) to 10 (worst possible). Scores range from 0-100, with lower scores indicating patient perceives fewer or no symptoms and higher scores indicating patient perceives worse symptoms.


Other Outcome Measures:
  • Health Care Service Utilization [ Time Frame: Baseline to 6 months after enrollment ] [ Designated as safety issue: No ]
    Health Services information will be summarized by review of medical records and administrative databases for number of unplanned hospitalizations, number of intensive care unit days, total length of hospital stay (days), number of emergency department visits, number of clinic office visits, number of home healthcare visits, time (in days) to hospice admission, and time (days) receiving hospice.


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Technology-Enhanced TPC
In addition to receiving usual palliative care service in the hospital setting, Technology-Enhanced Transitional Palliative Care patients will receive Transitional Care from the Palliative Care consulting team beginning in the hospital within 24 hours of study enrollment and continuing post discharge for eight weeks in their homes in rural locations by means of video visits with the Palliative Care consulting team.
Behavioral: Technology-Enhanced Transitional Palliative Care
The Transitional Care intervention will be initiated within 24 hours after enrollment, and will include initial transitional care planning, daily hospital visits, crisis prevention planning by an experienced Palliative Care nurse. The intervention will continue after the patient is discharged to home or short term skilled nursing facility, and it will involve an in-person visit between 24-48 hours post discharge, weekly virtual visits via iPad and video conference technology, and additional home visits as needed. Care plans established during initial planning will be implemented and adjusted under the guidance of the palliative care nurse delivering the intervention.
Usual standard of care
The control group will receive only the current standard palliative care service in the hospital setting, which includes standard in-hospital palliative care consultation and standard discharge planning.
Other: Usual Standard of Care
Usual care includes routine hospital discharge planning and usual physician care in primary and specialty outpatient clinics post hospital discharge. The PC consulting service provides consulting services in the inpatient setting. There are no standardized, intentional services provided to outpatients by the PC consulting team. Services provided to outpatients may occur sporadically as initiated by the patient. The majority of PC follow-up if any is a single phone call to the patient/caregiver. To account for the time spent and number of contacts made with the intervention group, the control group will be contacted by phone weekly by a non-nurse member of the study team not involved with the intervention, asked to relate what, if any, medically-related events occurred.

Detailed Description:

The purpose of the proposed research is to design and evaluate a technology enhanced transitional palliative care (TPC) intervention for patients living in rural locations. The contributions of the proposed research are expected to address the gap in palliative care services and transitions of care for rural patients. This research is significant because it addresses the challenges of three independently important health care foci - needs of rural patients, care transitions, and the evolving field of palliative care. The study will not simply address the critical barrier imposed by distance, but also extend PC practice by improving transition management for the impending dramatic increase in seriously ill and dying patients in rural areas through evolving demographic shifts. The goal of the proposed research is to advance the development of transitional care strategies for rural PC patients and caregivers, and provide evidence of new ways to support continuity of care for patients with life-limiting conditions.

The study is guided by the "Transitional Care Model" or "TCM" as developed by Naylor which combines quality, cost, and satisfaction. The TCM has a solid evidence base from more than 15 years of multidisciplinary research. Unique features of the model include care that is delivered and coordinated by the same nurse across hospital and home settings 7 days per week for an average of 2 to 3 months using evidence-based protocols with a focus on long term outcomes. Core components of the model include a holistic, person/family centered approach and protocol guided care. The nurse functions as part of an interdisciplinary team with shared accountability, however, the nurse is the single "point person" across an episode of care providing the vital link from hospital to home. Inherent within the model is shared communication systems that span care settings.

A randomized control trial design will be used. Community dwelling adult patients and their caregivers who receive a palliative care consult while hospitalized in the hospital will be enrolled in the study, then randomized to group membership and followed for a total of 8 weeks after hospital discharge. Following a detailed protocol for TPC, the intervention group will receive weekly video session visits (using computer software that allows audio/visual contact through the computer screen) by the study nurse. The investigators will determine the feasibility and acceptability of the TPC intervention and study methods and procedures when engaging palliative care patients and their caregivers. The investigators will compare patient and caregiver reported outcomes and determine effect size for patients receiving technology-enhanced TPC (intervention group) to patients in the control group, and they will explore the impact of the technology-enhanced TPC intervention on health care service utilization.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients hospitalized at study site, and their designated caregiver (if available)
  • Receiving palliative care
  • Returning home or to a facility for short term (30 days) rehabilitation
  • Able to provide informed consent
  • Able to complete self-reported questionnaires without assistance

Exclusion Criteria:

  • Long-term placement in skilled nursing facility after hospitalization
  • Receiving hospice
  • Living within city limits of hospital
  • Cognitive impairments
  • Non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934413

Locations
United States, Minnesota
Mayo Health System Recruiting
Mankato, Minnesota, United States, 56001
Contact: Jordan D Coffey    507-385-4785    Coffey.Jordan@mayo.edu   
Sub-Investigator: Cory J. Ingram, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Diane E Holland, PhD, RN Mayo Clinic
  More Information

No publications provided

Responsible Party: Diane Holland, Clinical Nurse Researcher, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01934413     History of Changes
Other Study ID Numbers: 13-006242
Study First Received: August 29, 2013
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Palliative Care
Technology
Rural
Transitional Care

ClinicalTrials.gov processed this record on November 23, 2014