Pain SMART: Shared Medical Appointments to Refocus Treatment

Chronic Pain Clinical Trial

Official title:

Pain SMART: Shared Medical Appointments to Refocus Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03707886
• Other study ID #: 02103-0001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: March 2020

Study information

• Verified date: October 2018
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study will test whether a shared medical appointment for Veterans with chronic pain is feasible and acceptable to veteran patients and their providers. The shared medical appointment, called Pain SMART (Shared Medical Appointments to Refocus Treatment), is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain. The overall goal of Pain SMART is to improve pain care for Veterans. Veterans will be randomized in equal numbers to either attend a Pain SMART visit or to receive educational information in the mail. The primary outcome of this pilot study is whether or not the shared medical appointment is feasible and acceptable to patients and providers.

Description:

Objectives: The primary purpose of this study is to understand the feasibility and acceptability of a shared medical appointment for patients with chronic pain called Pain SMART (Shared Medical Appointments to Refocus Treatment).

Intervention: The overall goal of Pain SMART is to increase the use of evidenced-based pain management strategies including pain self-management and other non-pharmacological pain management approaches. Pain SMART is a brief one-visit shared medical appointment delivered by primary care team members (e.g., primary care providers) and a behavioral health specialist (e.g., a clinical health psychologist). Pain SMART uses motivational interviewing to enhance effective and mutually rewarding communication among providers and Veterans to increase pain self-management, including uptake of non-pharmacological approaches to pain management, to ultimately enhance quality of care and Veteran functioning.

Study Participants: Primary care providers/staff will be recruited to participate in Pain SMART visits as shared medical appointment facilitators. Additionally, up to 80 veterans with chronic pain will be recruited.

Research Design: This study is a randomized pilot study in which Veteran participants are randomized to attend Pain SMART or to a minimally enhanced usual care condition (i.e., receive an educational brochure via mail). Veteran participants will be randomized in equal numbers to both conditions. Data collected from Veteran participants at baseline and three months following baseline; data will also be collected from primary care participants regarding their experience with Pain SMART. Data collection will include quantitative measures (e.g., information regarding pain and pain management approaches used) and qualitative measures (e.g., interviews about participants' experiences with Pain SMART).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Veteran Inclusion Criteria:

• Receives primary care from provider at VA Connecticut who is participating in the study

• Prescribed an opioid for chronic pain

Veteran Exclusion Criteria:

• Active suicidal ideation

• Psychotic disorder

• Active consult to opioid reassessment clinic at VA Connecticut

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Pain SMART
Pain SMART is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain to discuss pain management approaches.

Other:
• minimally enhanced usual care
The minimally enhanced usual care group will receive educational information via mail about non-pharmacological approaches to pain management.

Locations

Country	Name	City	State
United States	Va Connecticut Healthcare System	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System	VISN1 Career Development Award Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain management strategies used - Self-reported use of pain management strategies	We have developed a measure that asks participants if they have tried any pain management strategies in the past three months (e.g., acupuncture, cognitive behavioral therapy).	3 months
Primary	Feasibility of participant recruitment	ability to recruit Veterans to enroll in the study and attend group, as evidenced by randomizing 80 veterans over the study period and by having at least 60% of veterans randomized to attend the group show up to to the group	3 months
Secondary	Pain management strategies used - Chronic Pain Coping Inventory	The chronic pain coping inventory measures the use of pain self-management strategies (e.g., activity pacing)	3 months