Trial Outcomes & Findings for Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation (NCT NCT05270395)

NCT ID: NCT05270395

Last Updated: 2025-05-13

Results Overview

Enrollment feasibility is defined as the number of eligible and approached patients who agree to participate

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: up to 6 months
• Results posted on: 2025-05-13

Participant Flow

In this study, individuals were not randomized until they completed the baseline assessment. Although 75 participants were consented, only 68 completed baseline assessments and were randomized.

Participant milestones

Measure	mPal Intervention Participants in this group will receive the mPal intervention. 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. mPal's provider content (not randomized) will include education. System-level modifications will also be made to the electronic health record to facilitate palliative care discussions and referrals. mPal: 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.	Standard of Care Participants in this group will receive standard of care (applies to patients only).
Overall Study STARTED	34	34
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	mPal Intervention Participants in this group will receive the mPal intervention. 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. mPal's provider content (not randomized) will include education. System-level modifications will also be made to the electronic health record to facilitate palliative care discussions and referrals. mPal: 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.	Standard of Care Participants in this group will receive standard of care (applies to patients only).
Overall Study Lost to Follow-up	2	2
Overall Study Death	1	2
Overall Study Study Team Withdrew	1	0

Baseline Characteristics

Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation

Baseline characteristics by cohort

Measure	mPal Intervention n=34 Participants Participants in this group will receive the mPal intervention. 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. mPal's provider content (not randomized) will include education. System-level modifications will also be made to the electronic health record to facilitate palliative care discussions and referrals. mPal: 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.	Standard of Care n=34 Participants Participants in this group will receive standard of care (applies to patients only).	Total n=68 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 8.3 • n=5 Participants	61.0 years STANDARD_DEVIATION 11.5 • n=7 Participants	62.0 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	34 participants n=7 Participants	68 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Participants were not randomized until they completed baseline assessment, thus, this number is the total individuals eligible.

Enrollment feasibility is defined as the number of eligible and approached patients who agree to participate

Outcome measures

Measure	Eligible Participants n=118 Participants Participants eligible for study and approached to join study	Standard of Care Participants in this group will receive standard of care (applies to patients only).
Feasibility of Enrollment	75 Participants	—

SECONDARY outcome

Timeframe: up to 3-months post-intervention

Number of patients in each arm who receive a referral to palliative care within 1-month and 3-months post-intervention

Outcome measures

Measure	Eligible Participants n=34 Participants Participants eligible for study and approached to join study	Standard of Care n=34 Participants Participants in this group will receive standard of care (applies to patients only).
Patient Palliative Care Referrals	2 Participants	2 Participants

SECONDARY outcome

Timeframe: up to 2 weeks post-intervention viewing

Population: The intervention was only administered to the mPal arm. Participants that completed enough items to calculate a score were included.

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.

Outcome measures

Measure	Eligible Participants n=31 Participants Participants eligible for study and approached to join study	Standard of Care Participants in this group will receive standard of care (applies to patients only).
Acceptability of Intervention	3.95 score on a scale Standard Deviation 0.64	—

SECONDARY outcome

Timeframe: Baseline, up to 2-months post intervention

Population: Participants that completed enough items at the Time 2 assessment were included in the analysis

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=28 Participants Participants in this group will receive standard of care (applies to patients only).
Change in Palliative Care Attitudes	1.12 score on a scale Standard Error 1.33	-0.07 score on a scale Standard Error 1.37

SECONDARY outcome

Timeframe: up to 2 weeks post-intervention viewing

Population: Administered only to intervention participants; Participants that completed enough items at the Time 2 assessment were included in the analysis

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.

Outcome measures

Measure	Eligible Participants n=31 Participants Participants eligible for study and approached to join study	Standard of Care Participants in this group will receive standard of care (applies to patients only).
Feasibility of Intervention	4.03 score on a scale Standard Deviation 0.56	—

SECONDARY outcome

Timeframe: up to 2-months post-intervention

Feasibility of retention is defined as the number of patients who complete baseline and follow-up questionnaire

Outcome measures

Measure	Eligible Participants n=34 Participants Participants eligible for study and approached to join study	Standard of Care n=34 Participants Participants in this group will receive standard of care (applies to patients only).
Feasibility of Retention	30 Participants	30 Participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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").

Outcome measures

Measure	Eligible Participants n=28 Participants Participants eligible for study and approached to join study	Standard of Care n=28 Participants Participants in this group will receive standard of care (applies to patients only).
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?	35.71 Percentage of participants	14.29 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=27 Participants Participants in this group will receive standard of care (applies to patients only).
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	76.67 Percentage of participants	70.37 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=26 Participants Participants in this group will receive standard of care (applies to patients only).
Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support	73.33 Percentage of participants	88.46 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=26 Participants Participants in this group will receive standard of care (applies to patients only).
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	76.67 Percentage of participants	84.62 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=26 Participants Participants in this group will receive standard of care (applies to patients only).
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	26.67 Percentage of participants	15.38 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=27 Participants Participants in this group will receive standard of care (applies to patients only).
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	80.00 Percentage of participants	62.96 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=29 Participants Participants eligible for study and approached to join study	Standard of Care n=28 Participants Participants in this group will receive standard of care (applies to patients only).
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	72.41 Percentage of participants	67.86 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=27 Participants Participants in this group will receive standard of care (applies to patients only).
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	73.33 Percentage of participants	62.96 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=27 Participants Participants in this group will receive standard of care (applies to patients only).
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	66.67 Percentage of participants	48.15 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 1-month follow-up

Population: We analyzed all available cases at Time 2 assessment, which included participants that completed enough items to be included in the analysis.

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.

Outcome measures

Measure	Eligible Participants n=30 Participants Participants eligible for study and approached to join study	Standard of Care n=26 Participants Participants in this group will receive standard of care (applies to patients only).
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	70.00 Percentage of participants	34.62 Percentage of participants

Adverse Events

mPal Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. McLouth

University of Kentucky

Phone: 859-562-2526

Email: laurie.mclouth@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place