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

NCT ID: NCT01934413

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Palliative Care; Transitional Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Technology-Enhanced Transitional Palliative Care

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

Usual Standard of Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Diane Holland

Clinical Nurse Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diane E Holland, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Health System

Mankato, Minnesota, United States

Countries

United States

Other Identifiers

13-006242

Identifier Type: -

Identifier Source: org_study_id