Palliative Care Planner (PCplanner)

May 11, 2023 updated by: Duke University

The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial

The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Interstitial lung disease (ILD) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. Patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (ICU). Despite the presence of numerous unmet needs, ILD patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (ACP) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. To address this important clinical gap, we propose adapting our existing needs-targeted PCplanner (Palliative Care planner) mobile app platform to the outpatient setting. PCplanner Outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient has diagnosis of idiopathic pulmonary fibrosis
  • Patient has GAP (gender, age, physiology) index score ≥ 4
  • Patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit)

Exclusion Criteria:

  • Patient lacks fluency in English sufficient to complete study surveys
  • Patient is already seeing palliative care or enrolled in hospice
  • NEST score <10 at baseline T1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCplanner mobile app platform
Participants who are randomized to the intervention arm will complete surveys at 3 timepoints and will be given resources on advance care planning via PCplanner, the mobile app platform. They will receive a telephone call by the study team about a week after enrollment to answer any questions about the resources provided. If needs and questions are not resolved quickly after the clinic visit, then another layer of patient support with a telephone call by a palliative care specialist will be provided to the participant to help develop potential management plans.
Behavioral: PCplanner
A mobile app platform that will display participant survey results to clinicians to facilitate communication on specific needs as well as provide resources on advance care planning to participants.
No Intervention: Usual Care
Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of intervention
Time Frame: Up to 16 weeks
Number of participants who stated intervention was easy to use as measured by patient survey.
Up to 16 weeks
Acceptability of intervention
Time Frame: Up to 16 weeks
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Up to 16 weeks
Completion of intervention
Time Frame: Up to 16 weeks
Number of participants who completed all three surveys and intervention telephone visits.
Up to 16 weeks
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Time Frame: Baseline to week 8
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
Baseline to week 8
Documentation of advance care planning in electronic health record
Time Frame: Up to 16 weeks
Includes all or any of the following: code status, healthcare power of attorney, advance directive
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Time Frame: Baseline to week 16
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
Baseline to week 16
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time Frame: Baseline to week 8
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Baseline to week 8
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time Frame: Baseline to week 16
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Baseline to week 16
Change in General Anxiety Disorder-7 (GAD-7) score
Time Frame: Baseline to week 8
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Baseline to week 8
Change in General Anxiety Disorder-7 (GAD-7) score
Time Frame: Baseline to week 16
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Baseline to week 16
Change in Patient Health Questionnaire-10 (PHQ-10) score
Time Frame: Baseline to week 8
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Baseline to week 8
Change in Patient Health Questionnaire-10 (PHQ-10) score
Time Frame: Baseline to week 16
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Baseline to week 16
Change in EuroQol - 5 Dimension (EQ-5D) score
Time Frame: Baseline to week 8
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Baseline to week 8
Change in EuroQol - 5 Dimension (EQ-5D) score
Time Frame: Baseline to week 16
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Baseline to week 16
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Time Frame: Baseline to week 8
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Baseline to week 8
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Time Frame: Baseline to week 16
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Baseline to week 16
Change in Therapeutic Alliance score
Time Frame: Baseline to week 8
Score ranges from 16 to 64 with lower score indicates lower perceived alliance between patient and their provider and higher score indicates better therapeutic alliance.
Baseline to week 8
Change in Therapeutic Alliance score
Time Frame: Baseline to week 16
Score ranges from 16 to 64 with lower score indicates lower perceived alliance between patient and their provider and higher score indicates better therapeutic alliance.
Baseline to week 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hospitalizations during study
Time Frame: Up to 16 weeks
Admission to a hospital abstracted from electronic health record
Up to 16 weeks
Referral to palliative care specialist during study
Time Frame: Up to 16 weeks
Referral to palliative care specialist during study abstracted from electronic health record
Up to 16 weeks
Referral to hospice during study
Time Frame: Up to 16 weeks
Referral to inpatient or home hospice during study abstracted from electronic health record
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Christopher Cox, MD, Duke Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00108264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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