Trial Outcomes & Findings for Complementary Therapies in Palliative Care (NCT NCT02644356)

NCT ID: NCT02644356

Last Updated: 2017-03-17

Results Overview

Investigator-generated test of change in knowledge about theory, mechanisms of action, delivery, indications for use, evidence of efficacy; total of 45 multiple choice questions covering three modalities: acupuncture, massage, and music interventions. Range of total possible correct responses was from 0-45, with subscores as follows: range for acupuncture, 0-15; massage, 0-16; music interventions, 0-14. Total score is the sum of the combined subscores.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

51 participants

Primary outcome timeframe

Baseline, 30 days

Results posted on

2017-03-17

Participant Flow

Participant milestones

Participant milestones
Measure
Online CE/CME Course
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Overall Study
STARTED
51
Overall Study
COMPLETED
49
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Online CE/CME Course
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Overall Study
Withdrawal by Subject
2

Baseline Characteristics

Complementary Therapies in Palliative Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Online CE/CME Course
n=51 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Age, Continuous
43.8 years
STANDARD_DEVIATION 12.3 • n=99 Participants
Sex: Female, Male
Female
44 Participants
n=99 Participants
Sex: Female, Male
Male
7 Participants
n=99 Participants
Race/Ethnicity, Customized
White non-hispanic
29 participants
n=99 Participants
Race/Ethnicity, Customized
Asian American
8 participants
n=99 Participants
Race/Ethnicity, Customized
Hispanic
7 participants
n=99 Participants
Race/Ethnicity, Customized
Black
6 participants
n=99 Participants
Race/Ethnicity, Customized
American Indian
1 participants
n=99 Participants
Region of Enrollment
United States
51 participants
n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 30 days

Population: Disciplines: Nursing, 22; physician, 11; social work, 13; chaplaincy, 4; administrators, 4; counseling/psychology, 2 (some reported more than one discipline).

Investigator-generated test of change in knowledge about theory, mechanisms of action, delivery, indications for use, evidence of efficacy; total of 45 multiple choice questions covering three modalities: acupuncture, massage, and music interventions. Range of total possible correct responses was from 0-45, with subscores as follows: range for acupuncture, 0-15; massage, 0-16; music interventions, 0-14. Total score is the sum of the combined subscores.

Outcome measures

Outcome measures
Measure
Online CE/CME Course
n=49 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days
39.3 units on a scale
Standard Deviation 6.0

SECONDARY outcome

Timeframe: Baseline, 30 days

Population: There was missing data for one subject for this item.

Investigator-generated scale of confidence in understanding modality safety considerations. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.

Outcome measures

Outcome measures
Measure
Online CE/CME Course
n=48 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days
9.2 units on a scale
Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline, 30 days

Population: There was missing data for one subject for this item.

Investigator-generated scale of confidence in making evidence-based recommendations about the modality. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.

Outcome measures

Outcome measures
Measure
Online CE/CME Course
n=48 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days
9.4 units on a scale
Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline, 30 days

Population: There was missing data for one subject for this item.

Investigator-generated scale of confidence in communicating about the modality to patients, families and colleagues in PC contexts. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.

Outcome measures

Outcome measures
Measure
Online CE/CME Course
n=48 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days
8.9 units on a scale
Standard Deviation 1.6

SECONDARY outcome

Timeframe: 30 day follow-up

Population: There was missing data for one subject for this item.

Investigator-generated scale of perceived importance and relevance of course content: "How important is it for palliative care providers to know about non-pharmacological approaches to symptom management?" Likert scale ranges from 1 (not at all) to 4 (extremely).

Outcome measures

Outcome measures
Measure
Online CE/CME Course
n=48 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches
3.9 units on a scale
Standard Deviation 0.33

SECONDARY outcome

Timeframe: 30 day follow-up

Population: There was missing data for one subject for this item.

Investigator-generated scale of perceived importance and relevance of course content: "How relevant is the content of this course for increasing palliative care providers' knowledge of non-pharmacological approaches?" Likert scale ranges from 1 (not at all) to 4 (extremely).

Outcome measures

Outcome measures
Measure
Online CE/CME Course
n=48 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches
3.7 units on a scale
Standard Deviation 0.59

SECONDARY outcome

Timeframe: 30 day follow-up

Population: There was missing data for one subject for this item.

Investigator-generated scale of perceived importance and relevance of course content: "To what degree do you think this course could potentially contribute to improved patient care?" Likert scale ranges from 1 (not at all) to 4 (extremely).

Outcome measures

Outcome measures
Measure
Online CE/CME Course
n=48 Participants
Participant in taking the three course modules and completing pre- and post-course data collection. Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care
3.5 units on a scale
Standard Deviation 0.71

Adverse Events

Online CE/CME Course

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Collinge, PhD, MPH

Collinge and Associates, Inc.

Phone: 541-632-3502

Results disclosure agreements

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