CClinicalTrials.gg
CompletedNCT02644356CTPCUpdated Mar 17, 2017Results posted

Complementary Therapies in Palliative Care

A Phase 1 interventional study of Online CE/CME course in Health Care Provider Education, sponsored by Collinge and Associates, Inc.. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-17.

Sponsored by Collinge and Associates, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Palliative care represents one of the most rapidly expanding sectors of health care. Its rapid growth has been accompanied by widespread needs for training of multidisciplinary personnel to work with the unique set of health issues specific to its population of patients - not only those at end-of-life, but also patients with long-term, incurable, chronic and degenerative illnesses. This project will develop the first online continuing education program for palliative care personnel in the evidence-based application of complementary therapies, to enhance patient care and quality of life in the palliative care setting.

Read the detailed description

Palliative care represents one of the most rapidly expanding sectors of health care. Its rapid growth has been accompanied by widespread needs for training of multidisciplinary personnel to work with the unique set of health issues specific to its population of patients - not only those at end-of-life, but also patients with long-term, incurable, chronic and degenerative illnesses. Selected complementary therapies offer significant benefits for reducing suffering and improving quality of life in palliative care patients; however, there currently are no systematic educational offerings on the evidence-based application of such therapies in the palliative care setting. This project will develop the first online continuing education program for palliative care personnel in the evidence-based application of complementary therapies in the palliative care setting. The final product will consist of an interactive course with eight modules; Phase I will develop the web infrastructure for the course, and will then pilot test two modules to establish feasibility of the concept. The specific aims are as follows: Aim 1. Build a website capable of delivering an online interactive educational curriculum. Aim 2. Conduct evidence-based reviews of the literature on the application of complementary therapies to pain and dyspnea in palliative care settings. Aim 3. Incorporate the course content into a structure and form that can be effectively delivered over the website. Aim 4. Conduct peer review evaluation of content to determine fidelity of course content with available evidence. Aim 5. Recruit a multidisciplinary sample of health care personnel practicing in the field of palliative care. Aim 6. Conduct pilot testing of two modules of the program. Aim 7. Evaluate {attitudinal and} learning outcomes and user satisfaction feedback to determine feasibility of the approach. Feasibility of the approach will be determined by success in recruitment, compliance, evidence of meeting user learning objectives, and user satisfaction data. The final product to be developed is an eight-module online educational course for multidisciplinary health professionals in the evidence-based application of complementary therapies in palliative care. Commercial application will be as a continuing education program that is licensed to institutions (care facilities, hospitals, universities, colleges) as well as purchased by individual users (fee-based), with discipline-specific continuing education credits available, all administered over the internet. Impact and Innovation: This will be the first online educational program for palliative care personnel on this topic available in the US. The course will spearhead the expansion of the existing paradigm of palliative care to incorporate evidence-based integration of complementary therapies. Technological innovation includes the employment of fluid updating of content to licensees, which is a new development in online education and particularly important given the rapid rate of emergence of new data. Public health benefit: The course will aid in the improvement of quality of palliative care, benefitting potentially millions of recipients in the most rapidly expanding sector of the health care system.

02

Conditions studied

  • Health Care Provider Education
03

In context

Lead sponsor

Collinge and Associates, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Physicians (MD, DO), physician assistant (PA), nurse practitioner (NP), registered nurse (RN), licensed practical nurse (LPN), social worker (BA/BS/BSW, MSW, PhD/DSW), psychologist (MS/MA, PhD/PsyD), counselor (MS/MA),administrator, and chaplain.
  • Must be currently active within palliative care settings.

Exclusion criteria

Exclusion Criteria:

  • Professionals not actively working in palliative care settings
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Online CE/CME course

    Participant in taking the three course modules and completing pre- and post-course data collection.

    Behavioral: Online CE/CME course

Interventions

  • BehavioralOnline CE/CME course

    Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions

06

What researchers measure

Primary outcomes

  1. Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days

    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.

    Time frame: Baseline, 30 days

Secondary outcomes

  1. Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days

    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.

    Time frame: Baseline, 30 days

  2. Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days

    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.

    Time frame: Baseline, 30 days

  3. Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days

    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.

    Time frame: Baseline, 30 days

  4. Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches

    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).

    Time frame: 30 day follow-up

  5. Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches

    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).

    Time frame: 30 day follow-up

  6. Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care

    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).

    Time frame: 30 day follow-up

07

Results

Posted Mar 17, 2017

Participant flow

Participant flow — Overall Study
MilestoneOnline CE/CME Course
Started51
Completed49
Not completed2
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryChange in Test Scores on Knowledge of Course Content From Baseline to 30 Days

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.

Time frame:
Baseline, 30 days
Reported as:
Mean · units on a scale
Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days
units on a scaleOnline CE/CME Course
Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days39.3 ± 6.0
SecondaryChange in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days

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.

Time frame:
Baseline, 30 days
Reported as:
Mean · units on a scale
Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days
units on a scaleOnline CE/CME Course
Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days9.2 ± 1.6
SecondaryChange in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days

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.

Time frame:
Baseline, 30 days
Reported as:
Mean · units on a scale
Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days
units on a scaleOnline CE/CME Course
Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days9.4 ± 1.3
SecondaryChange in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days

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.

Time frame:
Baseline, 30 days
Reported as:
Mean · units on a scale
Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days
units on a scaleOnline CE/CME Course
Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days8.9 ± 1.6
SecondaryPerceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches

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).

Time frame:
30 day follow-up
Reported as:
Mean · units on a scale
Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches
units on a scaleOnline CE/CME Course
Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches3.9 ± 0.33
SecondaryPerceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches

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).

Time frame:
30 day follow-up
Reported as:
Mean · units on a scale
Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches
units on a scaleOnline CE/CME Course
Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches3.7 ± 0.59
SecondaryPerceived Course Relevance: Potential of Course to Contribute to Improved Patient Care

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).

Time frame:
30 day follow-up
Reported as:
Mean · units on a scale
Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care
units on a scaleOnline CE/CME Course
Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care3.5 ± 0.71

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Online CE/CME Course———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Online CE/CME Course
<=18 years0
Between 18 and 65 years51
>=65 years0
Age, Continuous
Age, Continuous(years)Online CE/CME Course
Mean43.8 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)Online CE/CME Course
Female44
Male7
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Online CE/CME Course
White non-hispanic29
Asian American8
Hispanic7
Black6
American Indian1
Region of Enrollment
Region of Enrollment(participants)Online CE/CME Course
United States51
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02644356
Lead sponsor
Collinge and Associates, Inc.
Collaborators
Kozak & Associates, LLC
Responsible party
William Collinge, PhD (President, Collinge and Associates, Inc.) — Principal investigator
First posted
Dec 31, 2015
Start date
Jul 2011
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Mar 17, 2017
Last update
Mar 17, 2017

Study contacts

William B Collinge, PhD, MPH
principal investigator · Collinge and Associates, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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