NCT01934413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.4 years

First QC Date

August 29, 2013

Last Update Submit

February 13, 2015

Conditions

Keywords

Palliative CareTechnologyRuralTransitional Care

Outcome Measures

Primary Outcomes (1)

  • Change in mean scores on FACIT-Pal Questionnaire

    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.

    Baseline, 1 month post-enrollment, 2 months post-enrollment

Secondary Outcomes (1)

  • Change in mean scores on ESAS-r Questionnaire

    Baseline, 1 month post-enrollment, 2 months post-enrollment

Other Outcomes (1)

  • Health Care Service Utilization

    Baseline to 6 months after enrollment

Study Arms (2)

Technology-Enhanced TPC

ACTIVE COMPARATOR

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

Usual standard of care

OTHER

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

Interventions

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.

Technology-Enhanced TPC

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.

Usual standard of care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Long-term placement in skilled nursing facility after hospitalization
  • Receiving hospice
  • Living within city limits of hospital
  • Cognitive impairments
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Health System

Mankato, Minnesota, 56001, United States

Location

Study Officials

  • Diane E Holland, PhD, RN

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Researcher

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 4, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations