Pain and Symptom Management in Rural Communities

NCT ID: NCT02070874

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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telehealth enhanced pain management

video-case conferences for providers PainTracker for patients

Group Type EXPERIMENTAL

telehealth enhanced pain management

Intervention Type BEHAVIORAL

usual care

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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telehealth enhanced pain management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Ardith Doorenbos

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23817285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24846620 (View on PubMed)

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.

Reference Type RESULT
PMID: 25616057 (View on PubMed)

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.

Reference Type RESULT
PMID: 25964869 (View on PubMed)

Other Identifiers

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R01NR012450

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002019

Identifier Type: -

Identifier Source: org_study_id

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