The purpose of this study is to assess the feasibility and acceptability of mPal, a multilevel implementation strategy to improve palliative care use among advanced stage lung cancer patients receiving cancer treatment.
In this study, 60 advanced stage lung cancer patients will be randomized to mPal's patient-level component or usual care. Oncology providers will receive the mPal intervention. mPal is designed to help oncology providers integrate outpatient palliative care (non-hospice palliative care; NHPC) into routine clinical practice through: 1) electronic health record enhancements; 2) patient education and preparation for NHPC discussions when patients are in clinic to see their oncology providers; and 3) provider education about NHPC. This study will examine the feasibility and acceptability of mPal and gather preliminary data on potential outcomes for a future effectiveness trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
75
mPal's patient content includes a multi-component web-based tool with the following: (1) a brief educational video that seeks to educate patients about palliative care; (2) and assessment of palliative care knowledge; (3) assessment of palliative care needs; and (4) an assessment of whether patients would like to meet with palliative care or discuss palliative care and their palliative care needs with their oncology provider. The provider-level component includes provider education on palliative care. The system-level component includes electronic health record modifications to facilitate palliative care discussions and referrals.
University of Kentucky
Lexington, Kentucky, United States
Feasibility of Enrollment
Enrollment feasibility is defined as the number of eligible and approached patients who agree to participate
Time frame: up to 6 months
Patient Palliative Care Referrals
Number of patients in each arm who receive a referral to palliative care within 1-month and 3-months post-intervention
Time frame: up to 3-months post-intervention
Acceptability of Intervention
4-item acceptability of intervention measure (AIM); items responded to on a 5-point Likert-type scale (1 - 5) with higher scores indicating greater acceptability.
Time frame: up to 2 weeks post-intervention viewing
Change in Palliative Care Attitudes
Palliative Care Attitudes Scale; 9-items responded to on a Likert-type scale (range 9 - 60) with higher scores indicating more favorable attitudes and motivation towards palliative care. Mean change in total score at Time 2 is presented, adjusted for the baseline value of PCAS Total Score at baseline, age, and sex.
Time frame: Baseline, up to 2-months post intervention
Feasibility of Intervention
4-item feasibility of intervention measure (FIM); items responded to on a 5-point Likert-type scale (1 - 5) with higher scores indicating higher feasibility.
Time frame: up to 2 weeks post-intervention viewing
Feasibility of Retention
Feasibility of retention is defined as the number of patients who complete baseline and follow-up questionnaire
Time frame: up to 2-months post-intervention
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Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 1: How Would You Describe Your Level of Knowledge About Palliative Care?
The percentage of participants responding, "know what palliative care is and could explain it to someone else" reported. Odds ratio was calculated using logistic regression. Item 1 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to respond to this question: "How would you describe your level of knowledge about palliative care?" Participants can respond, "I've never heard of it," "I know a little bit about palliative care," or "I know what palliative care is and could explain it to someone else." For the analysis, the first two responses were collapsed to create a dichotomous variable ("have no or little knowledge of palliative care" versus "know what palliative care is and could explain it to someone else").
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 2: Help Friends and Family to Cope With a Patient's Illness
The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression. Item 2 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Help friends and family to cope with a patient's illness." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree" ("Strongly agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified correct knowledge of palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support
The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression. Item 3 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Offer social and emotional support." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree" ("Strongly agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified correct knowledge of palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 4: Manage Pain and Other Physical Symptoms
The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression. Item 4 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Manage pain and other physical symptoms." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree" ("Strongly agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified correct knowledge of palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 5: Give Patients More Time at the End of Life
The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression. Item 5 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement regarding the goal of palliative care: "Give patients more time at the end of life." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree/Don't know" ("Strongly agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified correct knowledge of palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 6: Accepting Palliative Care Means Giving up
The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression. Item 6 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement about palliative care: "Accepting palliative care means giving up." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree/Don't know" ("Strongly agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified positive belief about palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 7: It is a Doctor's Obligation to Inform All Patients With Cancer About the Option of Palliative Care
The percentage of participants responding, "Agree" reported. Odds ratio was calculated using logistic regression. Item 7 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement about palliative care: "It is a doctor's obligation to inform all patients with cancer about the option of palliative care." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree" ("Strongly agree" or "Somewhat agree") versus "Disagree/Don't know" ("Somewhat disagree," "Strongly disagree," or "Don't know"). For this item, "Agree" signified positive belief about palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 8: If You Accept Palliative Care, You Must Stop Other Treatments
The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression. Item 8 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement about palliative care: "If you accept palliative care, you must stop other treatments." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree/Don't know" ("Strongly agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified correct knowledge of palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 9: Palliative Care is the Same as Hospice Care
The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression. Item 9 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement about palliative care: "Palliative care is the same as hospice care." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree/Don't know" ("Strongly agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified correct knowledge of palliative care.
Time frame: Baseline and at 1-month follow-up
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 10: When I Think of "Palliative Care," I Automatically Think of Death
The percentage of participants responding, "Disagree" reported. Odds ratio was calculated using logistic regression. Item 10 in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS) asks participants to state the degree to which they agree or disagree with this statement about palliative care: "When I think of "palliative care," I automatically think of death." Participants can respond, "Strongly agree," "Somewhat agree," "Somewhat disagree," "Strongly disagree," or "Don't know." For the analysis, we dichotomized the responses into "Agree/Don't know" ("Strongly agree," "Somewhat agree," or "Don't know") versus "Disagree" ("Somewhat disagree" or "Strongly disagree"). For this item, "Disagree" signified positive belief about palliative care.
Time frame: Baseline and at 1-month follow-up