NCT02070874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

5.3 years

First QC Date

February 20, 2014

Last Update Submit

August 9, 2017

Conditions

Keywords

pain and symptom management

Outcome Measures

Primary Outcomes (1)

  • pain

    pain severity

    12 weeks

Secondary Outcomes (1)

  • PHQ 4

    12 weeks

Other Outcomes (1)

  • cost

    12 weeks

Study Arms (2)

telehealth enhanced pain management

EXPERIMENTAL

video-case conferences for providers PainTracker for patients

Behavioral: telehealth enhanced pain management

usual care

NO INTERVENTION

usual care

Interventions

telehealth enhanced pain management

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (4)

  • 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.

    PMID: 23817285BACKGROUND
  • 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.

    PMID: 24846620BACKGROUND
  • 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.

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 25, 2014

Study Start

April 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 11, 2017

Record last verified: 2017-08

Locations