Complementary Therapies in Palliative Care

Palliative Care Provider Online Education in Evidence-Based Complementary Therapies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02644356

Acronym

CTPC

Enrollment

Registered

2015-12-31

Start date

2011-07-31

Completion date

2013-12-31

Last updated

2017-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Care Provider Education

Brief summary

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.

Interventions

BEHAVIORALOnline CE/CME course

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* Professionals not actively working in palliative care settings

Design outcomes

Primary

Measure	Time frame	Description
Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days	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.

Secondary

Measure	Time frame	Description
Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days	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.
Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days	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.
Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days	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.
Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches	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).
Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care	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).
Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches	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).

Participant flow

Participants by arm

Arm	Count
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	51
Total	51

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Online CE/CME Course
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	51 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 12.3
Race/Ethnicity, Customized American Indian	1 participants
Race/Ethnicity, Customized Asian American	8 participants
Race/Ethnicity, Customized Black	6 participants
Race/Ethnicity, Customized Hispanic	7 participants
Race/Ethnicity, Customized White non-hispanic	29 participants
Region of Enrollment United States	51 participants
Sex: Female, Male Female	44 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

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

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

Arm	Measure	Value (MEAN)	Dispersion
Online CE/CME Course	Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days	39.3 units on a scale	Standard Deviation 6

Secondary

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