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Pain and Symptom Management in Rural Communities (TelePain)

Primary Purpose

Chronic Pain, Palliative Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telehealth enhanced pain management
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring pain and symptom management

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years of age
  • diagnosed with pain
  • completion of an outpatient visit in the past 2 months
  • functional fluency in English
  • no cognitive impairment
  • no problems with regular phone lines

Exclusion Criteria:

-

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

telehealth enhanced pain management

usual care

Arm Description

video-case conferences for providers PainTracker for patients

usual care

Outcomes

Primary Outcome Measures

pain
pain severity

Secondary Outcome Measures

PHQ 4
anxiety and depressive symptoms

Full Information

First Posted
February 20, 2014
Last Updated
August 9, 2017
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT02070874
Brief Title
Pain and Symptom Management in Rural Communities
Acronym
TelePain
Official Title
Palliative Care Symptom Management in Rural Communities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients in isolated rural settings often lack easy access to pain care and specialist services. Yet rural residents are more likely than their urban counterparts to be older; be in poorer overall health; suffer from more chronic or serious illnesses and disabilities; be uninsured or underinsured; and live in poverty. Telehealth is an emerging method of health care delivery that has been found useful and effective in many clinical settings and specialties. Telehealth technologies can bridge geographic distance and increase access to specialist care in rural settings. The investigators propose a cluster randomized clinical trial design to test the effects of a telehealth-enhanced palliative care pain-management program for 240 patients and 40 providers in rural health care settings. The proposed program will provide services to both patients and providers: Patients will conduct self-assessments and report pain and other symptoms via telehealth. Health care providers will receive telehealth-delivered case consultations that will include case management, evidence-based practice resources, and peer support. Providers and their patients will be randomly assigned to intervention groups, which receive the telehealth-enhanced palliative care pain-management intervention, or to control groups. The investigators primary aim is to compare patient self-reports of pain and quality of life in the intervention and control groups over 2 months. Aim 2 is to examine, in the intervention and control groups over 2 months, providers' knowledge and attitudes regarding pain and perceived competence in treating pain. Aim 3 is to evaluate the cost-effectiveness of the telehealth intervention. The investigators will use mixed effects models with patients nested within providers to evaluate the effect of the intervention on study outcomes. Findings from this study will be instrumental in advancing telehealth and improving pain management and palliative care among underserved rural populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Palliative Care
Keywords
pain and symptom management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
telehealth enhanced pain management
Arm Type
Experimental
Arm Description
video-case conferences for providers PainTracker for patients
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
telehealth enhanced pain management
Primary Outcome Measure Information:
Title
pain
Description
pain severity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PHQ 4
Description
anxiety and depressive symptoms
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
cost
Description
HUI-3
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years of age diagnosed with pain completion of an outpatient visit in the past 2 months functional fluency in English no cognitive impairment no problems with regular phone lines Exclusion Criteria: -
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23817285
Citation
Bensink ME, Eaton LH, Morrison ML, Cook WA, Curtis RR, Gordon DB, Kundu A, Doorenbos AZ. Cost effectiveness analysis for nursing research. Nurs Res. 2013 Jul-Aug;62(4):279-85. doi: 10.1097/NNR.0b013e318298b0be.
Results Reference
background
PubMed Identifier
24846620
Citation
Eaton LH, Gordon DB, Wyant S, Theodore BR, Meins AR, Rue T, Towle C, Tauben D, Doorenbos AZ. Development and implementation of a telehealth-enhanced intervention for pain and symptom management. Contemp Clin Trials. 2014 Jul;38(2):213-20. doi: 10.1016/j.cct.2014.05.005. Epub 2014 May 17.
Results Reference
background
PubMed Identifier
25616057
Citation
Theodore BR, Whittington J, Towle C, Tauben DJ, Endicott-Popovsky B, Cahana A, Doorenbos AZ. Transaction cost analysis of in-clinic versus telehealth consultations for chronic pain: preliminary evidence for rapid and affordable access to interdisciplinary collaborative consultation. Pain Med. 2015 Jun;16(6):1045-56. doi: 10.1111/pme.12688. Epub 2015 Jan 23.
Results Reference
result
PubMed Identifier
25964869
Citation
Meins AR, Doorenbos AZ, Eaton L, Gordon D, Theodore B, Tauben D. TelePain: A Community of Practice for Pain Management. J Pain Relief. 2015 Mar 11;4(2):177. doi: 10.4172/2167-0846.1000177.
Results Reference
result

Learn more about this trial

Pain and Symptom Management in Rural Communities

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