- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644356
Complementary Therapies in Palliative Care (CTPC)
January 30, 2017 updated by: William Collinge, PhD, Collinge and Associates, Inc.
Palliative Care Provider Online Education in Evidence-Based Complementary Therapies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- Professionals not actively working in palliative care settings
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online CE/CME course
Participant in taking the three course modules and completing pre- and post-course data collection.
|
Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days
Time Frame: Baseline, 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.
|
Baseline, 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days
Time Frame: Baseline, 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.
|
Baseline, 30 days
|
Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days
Time Frame: Baseline, 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.
|
Baseline, 30 days
|
Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days
Time Frame: Baseline, 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.
|
Baseline, 30 days
|
Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches
Time Frame: 30 day follow-up
|
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).
|
30 day follow-up
|
Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches
Time Frame: 30 day follow-up
|
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).
|
30 day follow-up
|
Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care
Time Frame: 30 day follow-up
|
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).
|
30 day follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William B Collinge, PhD, MPH, Collinge and Associates, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
December 12, 2015
First Submitted That Met QC Criteria
December 29, 2015
First Posted (Estimate)
December 31, 2015
Study Record Updates
Last Update Posted (Actual)
March 17, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- R43CA157005 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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