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Clinical Trials/NCT01934413
NCT01934413CompletedNot Applicable

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

Mayo Clinic2 sites in 1 country17 target enrollmentStarted: September 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
2
Primary Endpoint
Change in mean scores on FACIT-Pal Questionnaire

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in mean scores on FACIT-Pal Questionnaire

Time Frame: Baseline, 1 month post-enrollment, 2 months post-enrollment

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 Outcomes

  • Change in mean scores on ESAS-r Questionnaire(Baseline, 1 month post-enrollment, 2 months post-enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Diane Holland

Clinical Nurse Researcher

Mayo Clinic

Study Sites (2)

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