Palliative Care Planner (PCplanner)

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095363
• Other study ID #: Pro00108264
• Status: Completed
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Au DH, Udris EM, Fihn SD, McDonell MB, Curtis JR. Differences in health care utilization at the end of life among patients with chronic obstructive pulmonary disease and patients with lung cancer. Arch Intern Med. 2006 Feb 13;166(3):326-31. doi: 10.1001/archinte.166.3.326. — View Citation

Bajwah S, Higginson IJ, Ross JR, Wells AU, Birring SS, Patel A, Riley J. Specialist palliative care is more than drugs: a retrospective study of ILD patients. Lung. 2012 Apr;190(2):215-20. doi: 10.1007/s00408-011-9355-7. Epub 2012 Jan 5. — View Citation

Bausewein C, Booth S, Gysels M, Kuhnbach R, Haberland B, Higginson IJ. Understanding breathlessness: cross-sectional comparison of symptom burden and palliative care needs in chronic obstructive pulmonary disease and cancer. J Palliat Med. 2010 Sep;13(9):1109-18. doi: 10.1089/jpm.2010.0068. — View Citation

Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax. 2000 Dec;55(12):1000-6. doi: 10.1136/thorax.55.12.1000. — View Citation

Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29. — View Citation

Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004. — View Citation

Moens K, Higginson IJ, Harding R; EURO IMPACT. Are there differences in the prevalence of palliative care-related problems in people living with advanced cancer and eight non-cancer conditions? A systematic review. J Pain Symptom Manage. 2014 Oct;48(4):660-77. doi: 10.1016/j.jpainsymman.2013.11.009. Epub 2014 May 5. — View Citation

Olson A, Hartmann N, Patnaik P, Wallace L, Schlenker-Herceg R, Nasser M, Richeldi L, Hoffmann-Vold AM, Cottin V. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey. Adv Ther. 2021 Feb;38(2):854-867. doi: 10.1007/s12325-020-01578-6. Epub 2020 Dec 14. — View Citation

Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91. doi: 10.1001/archinte.164.1.83. — View Citation

Ryerson CJ, Vittinghoff E, Ley B, Lee JS, Mooney JJ, Jones KD, Elicker BM, Wolters PJ, Koth LL, King TE Jr, Collard HR. Predicting survival across chronic interstitial lung disease: the ILD-GAP model. Chest. 2014 Apr;145(4):723-728. doi: 10.1378/chest.13-1474. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of hospitalizations during study	Admission to a hospital abstracted from electronic health record	Up to 16 weeks
Other	Referral to palliative care specialist during study	Referral to palliative care specialist during study abstracted from electronic health record	Up to 16 weeks
Other	Referral to hospice during study	Referral to inpatient or home hospice during study abstracted from electronic health record	Up to 16 weeks
Primary	Feasibility of intervention	Number of participants who stated intervention was easy to use as measured by patient survey.	Up to 16 weeks
Primary	Acceptability of intervention	Number of participants who stated they were satisfied with the intervention as measured by patient survey.	Up to 16 weeks
Primary	Completion of intervention	Number of participants who completed all three surveys and intervention telephone visits.	Up to 16 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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