Palliative Care Planner (PCplanner)

Not Applicable

Completed

• Conditions: Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis
• Interventions: Behavioral: PCplanner

• Registration Number: NCT05095363
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Study Start: 2022-03-16
• Status Verified: 2023-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCplanner mobile app platform	PCplanner	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of intervention	Up to 16 weeks	Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Documentation of advance care planning in electronic health record	Up to 16 weeks	Includes all or any of the following: code status, healthcare power of attorney, advance directive
Feasibility of intervention	Up to 16 weeks	Number of participants who stated intervention was easy to use as measured by patient survey.
Completion of intervention	Up to 16 weeks	Number of participants who completed all three surveys and intervention telephone visits.
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale	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.

Secondary Outcome Measures

Name	Time	Method
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale	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.
Change in General Anxiety Disorder-7 (GAD-7) score	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.
Change in Patient Health Questionnaire-9 (PHQ-9) score	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.
Change in Quality of Life Visual Analogue Scale (QOL VAS)	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.
Change in Patient Health Questionnaire-10 (PHQ-10) score	Baseline to week 16	Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Change in Therapeutic Alliance score	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.
Change in EuroQol - 5 Dimension (EQ-5D) score	Baseline to week 16	Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States