Pain and Symptom Management in Rural Communities

Chronic Pain Clinical Trial

— TelePain  

Official title:

Palliative Care Symptom Management in Rural Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070874
• Other study ID #: STUDY00002019
• Secondary ID: R01NR012450
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: August 9, 2017
• Start date: April 2012
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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:

Related Conditions & MeSH terms

• Chronic Pain
• Palliative Care

Intervention

Behavioral:
• telehealth enhanced pain management

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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). pii: 177. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cost	HUI-3	12 weeks
Primary	pain	pain severity	12 weeks
Secondary	PHQ 4	anxiety and depressive symptoms	12 weeks