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Pain SMART: Shared Medical Appointments to Refocus Treatment

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain SMART
minimally enhanced usual care
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring chronic pain, shared medical appointment, veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Va Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pain SMART (Intervention Arm)

Minimally Enhanced Usual Care

Arm Description

The Intervention Arm will be invited to participate in a one-time group intervention, Pain SMART

The Minimally Enhanced Usual Care group will receive educational information via mail.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
August 28, 2018
Last Updated
October 14, 2018
Sponsor
VA Connecticut Healthcare System
Collaborators
VISN1 Career Development Award Program
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1. Study Identification

Unique Protocol Identification Number
NCT03707886
Brief Title
Pain SMART: Shared Medical Appointments to Refocus Treatment
Official Title
Pain SMART: Shared Medical Appointments to Refocus Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
Collaborators
VISN1 Career Development Award Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, shared medical appointment, veterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain SMART (Intervention Arm)
Arm Type
Experimental
Arm Description
The Intervention Arm will be invited to participate in a one-time group intervention, Pain SMART
Arm Title
Minimally Enhanced Usual Care
Arm Type
Placebo Comparator
Arm Description
The Minimally Enhanced Usual Care group will receive educational information via mail.
Intervention Type
Behavioral
Intervention Name(s)
Pain SMART
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
minimally enhanced usual care
Intervention Description
The minimally enhanced usual care group will receive educational information via mail about non-pharmacological approaches to pain management.
Primary Outcome Measure Information:
Title
Feasibility of participant recruitment
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain management strategies used - Chronic Pain Coping Inventory
Description
The chronic pain coping inventory measures the use of pain self-management strategies (e.g., activity pacing)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Pain management strategies used - Self-reported use of pain management strategies
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Va Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain SMART: Shared Medical Appointments to Refocus Treatment

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