Clinical trial NCT01934413: Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study
Official title: Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Transitional Care
Keywords: Palliative Care
Technology
Rural
Transitional Care
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in mean scores on FACIT-Pal Questionnaire
timeFrame: Baseline, 1 month post-enrollment, 2 months post-enrollment
Secondary outcomes:
measure: Change in mean scores on ESAS-r Questionnaire
timeFrame: Baseline, 1 month post-enrollment, 2 months post-enrollment
Other outcomes:
measure: Health Care Service Utilization
timeFrame: Baseline to 6 months after enrollment
Locations:
city: Mankato
country: United States
facility: Mayo Health System
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Diane E Holland, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: