Health Care Provider EducationPhase 1CTPCNCT02644356
Complementary Therapies in Palliative Care
A Phase 1 study testing Online CE/CME course in people with Health Care Provider Education, run by Collinge and Associates, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Provider Education
- What is being tested?
- Online CE/CME course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Professionals not actively working in palliative care settings
About this study
Official title: 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.
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.
- Conditions
- Health Care Provider Education
- Being tested
- Online CE/CME course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online CE/CME courseBehavioural
Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
| Study group | Role | What they receive |
|---|---|---|
| Online CE/CME course | Experimental | Participant in taking the three course modules and completing pre- and post-course data collection. Receives: Behavioral: Online CE/CME course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 30 days
Secondary outcomes (6)
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.
Measured: Baseline, 30 days
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.
Measured: Baseline, 30 days
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.
Measured: Baseline, 30 days
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).
Measured: 30 day follow-up
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).
Measured: 30 day follow-up
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).
Measured: 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health Care Provider EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collinge and Associates, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Kozak & Associates, LLC
- Responsible party
- Principal investigator, William Collinge, PhD, Collinge and Associates, Inc.
- Investigators
- William B Collinge, PhD, MPH, Principal investigator, Collinge and Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644356
- Sponsor's protocol ID
- R43CA157005
- Acronym
- CTPC
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2015
- Last updated
- 17 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Provider Online Education in Evidence-Based Complementary Therapies
- ClinicalTrials.gov ID
- NCT02644356
- Acronym / sponsor ID
- CTPC / R43CA157005
- Conditions
- Health Care Provider Education
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Collinge and Associates, Inc.University, hospital or other
- Collaborators
- Kozak & Associates, LLC
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 17 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online CE/CME course | Experimental | Behavioral: Online CE/CME courseParticipant in taking the three course modules and completing pre- and post-course data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Professionals not actively working in palliative care settings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online CE/CME courseEducational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions | Behavioural | Online CE/CME course |
Primary outcome
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.
6 secondary outcomes
Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days
Time frame: 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
Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days
Time frame: Baseline, 30 days
Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches
Time frame: 30 day follow-up
Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches
Time frame: 30 day follow-up
Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care
Time frame: 30 day follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Health Care Provider Education
Not yet recruiting
Health Care Professionals Diet App Study
Nutrition Education
Active, not recruiting
Patient Safety Competency-Building Program for Healthcare Professionals in Pediatric Cardiac Critical Care in Ethiopia
Patient Safety, Patient Safety Education
Recruiting
Effectiveness of a Combined e-Learning and Virtual Reality Training Program for Healthcare Providers in Rheumatology
Rheumatic Diseases
Active, not recruitingPhase 3
Evaluation of a Disability-Focused Sexual and Reproductive Health Curriculum for Health Students in Tanzania
Sexual and Reproductive Health, Disability
Not yet recruiting
Effects of a Sleep Education Program on the Health Status of Healthcare Workers Working 12-hour Alternating Day-night Shifts
Healthy Volunteers (HV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Collinge, PhD, MPH principal investigator
Collinge and Associates, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Online CE/CME course in people with Health Care Provider Education, run by Collinge and Associates, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days (time frame: Baseline, 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.