Palliative Care Planner (PCplanner)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial

Conditions
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Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Behavioral: PCplanner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCplanner mobile app platform<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention | Number of participants who stated intervention was easy to use as measured by patient survey. | Up to 16 weeks | 
| Acceptability of intervention | Number of participants who stated they were satisfied with the intervention as measured by patient survey. | Up to 16 weeks | 
| Completion of intervention | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, advance care planning