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Palliative Care Planner (PCplanner)

Primary Purpose

Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCplanner
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Interstitial Lung Disease focused on measuring palliative care, advance care planning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PCplanner mobile app platform

Usual Care

Arm Description

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.

Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician.

Outcomes

Primary Outcome Measures

Feasibility of intervention
Number of participants who stated intervention was easy to use as measured by patient survey.
Acceptability of intervention
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Completion of intervention
Number of participants who completed all three surveys and intervention telephone visits.
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
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.
Documentation of advance care planning in electronic health record
Includes all or any of the following: code status, healthcare power of attorney, advance directive

Secondary Outcome Measures

Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
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.
Change in Patient Health Questionnaire-9 (PHQ-9) score
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Change in Patient Health Questionnaire-9 (PHQ-9) score
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Change in General Anxiety Disorder-7 (GAD-7) score
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Change in General Anxiety Disorder-7 (GAD-7) score
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Change in Patient Health Questionnaire-10 (PHQ-10) score
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Change in Patient Health Questionnaire-10 (PHQ-10) score
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Change in EuroQol - 5 Dimension (EQ-5D) score
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Change in EuroQol - 5 Dimension (EQ-5D) score
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Change in Therapeutic Alliance score
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.
Change in Therapeutic Alliance score
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.

Full Information

First Posted
October 15, 2021
Last Updated
May 11, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05095363
Brief Title
Palliative Care Planner (PCplanner)
Official Title
The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
Keywords
palliative care, advance care planning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Palliative Care planner (PCplanner) is a mobile app platform that aims to facilitate communication on unmet needs and advance care planning between patients with idiopathic pulmonary fibrosis and their pulmonary clinicians. Participants will be randomized to intervention arm in a 2:1 intervention:control ratio.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCplanner mobile app platform
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician.
Intervention Type
Behavioral
Intervention Name(s)
PCplanner
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of intervention
Description
Number of participants who stated intervention was easy to use as measured by patient survey.
Time Frame
Up to 16 weeks
Title
Acceptability of intervention
Description
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Time Frame
Up to 16 weeks
Title
Completion of intervention
Description
Number of participants who completed all three surveys and intervention telephone visits.
Time Frame
Up to 16 weeks
Title
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Description
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.
Time Frame
Baseline to week 8
Title
Documentation of advance care planning in electronic health record
Description
Includes all or any of the following: code status, healthcare power of attorney, advance directive
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Description
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.
Time Frame
Baseline to week 16
Title
Change in Patient Health Questionnaire-9 (PHQ-9) score
Description
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Time Frame
Baseline to week 8
Title
Change in Patient Health Questionnaire-9 (PHQ-9) score
Description
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Time Frame
Baseline to week 16
Title
Change in General Anxiety Disorder-7 (GAD-7) score
Description
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Time Frame
Baseline to week 8
Title
Change in General Anxiety Disorder-7 (GAD-7) score
Description
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Time Frame
Baseline to week 16
Title
Change in Patient Health Questionnaire-10 (PHQ-10) score
Description
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Time Frame
Baseline to week 8
Title
Change in Patient Health Questionnaire-10 (PHQ-10) score
Description
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Time Frame
Baseline to week 16
Title
Change in EuroQol - 5 Dimension (EQ-5D) score
Description
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Time Frame
Baseline to week 8
Title
Change in EuroQol - 5 Dimension (EQ-5D) score
Description
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Time Frame
Baseline to week 16
Title
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Description
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Time Frame
Baseline to week 8
Title
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Description
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Time Frame
Baseline to week 16
Title
Change in Therapeutic Alliance score
Description
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.
Time Frame
Baseline to week 8
Title
Change in Therapeutic Alliance score
Description
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.
Time Frame
Baseline to week 16
Other Pre-specified Outcome Measures:
Title
Number of hospitalizations during study
Description
Admission to a hospital abstracted from electronic health record
Time Frame
Up to 16 weeks
Title
Referral to palliative care specialist during study
Description
Referral to palliative care specialist during study abstracted from electronic health record
Time Frame
Up to 16 weeks
Title
Referral to hospice during study
Description
Referral to inpatient or home hospice during study abstracted from electronic health record
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Cox, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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