TelePain: Pain and Symptom Management in Rural Communities

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT02070874
Collaborator
National Institute of Nursing Research (NINR) (NIH)
259
1
2
63
4.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: telehealth enhanced pain management
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
259 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Palliative Care Symptom Management in Rural Communities
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: telehealth enhanced pain management

video-case conferences for providers PainTracker for patients

Behavioral: telehealth enhanced pain management

No Intervention: usual care

usual care

Outcome Measures

Primary Outcome Measures

  1. pain [12 weeks]

    pain severity

Secondary Outcome Measures

  1. PHQ 4 [12 weeks]

    anxiety and depressive symptoms

Other Outcome Measures

  1. cost [12 weeks]

    HUI-3

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington
  • National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ardith Doorenbos, Associate Professor, University of Washington
ClinicalTrials.gov Identifier:
NCT02070874
Other Study ID Numbers:
  • STUDY00002019
  • R01NR012450
First Posted:
Feb 25, 2014
Last Update Posted:
Aug 11, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Ardith Doorenbos, Associate Professor, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2017