Pain and Symptom Management in Rural Communities (TelePain)

Palliative Care Symptom Management in Rural Communities

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Palliative Care
• Intervention / Treatment: Behavioral: telehealth enhanced pain management

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care
Experimental: telehealth enhanced pain management; video-case conferences for providers PainTracker for patients	Behavioral: telehealth enhanced pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	pain severity	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ 4	anxiety and depressive symptoms	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
cost	HUI-3	12 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: pain and symptom management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: STUDY00002019; R01NR012450 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided