Pain SMART: Shared Medical Appointments to Refocus Treatment
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|ClinicalTrials.gov Identifier: NCT03707886|
Recruitment Status : Unknown
Verified October 2018 by VA Connecticut Healthcare System.
Recruitment status was: Enrolling by invitation
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Pain SMART Other: minimally enhanced usual care||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pain SMART: Shared Medical Appointments to Refocus Treatment|
|Actual Study Start Date :||August 31, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Pain SMART (Intervention Arm)
The Intervention Arm will be invited to participate in a one-time group intervention, Pain SMART
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.
Placebo Comparator: Minimally Enhanced Usual Care
The Minimally Enhanced Usual Care group will receive educational information via mail.
Other: minimally enhanced usual care
The minimally enhanced usual care group will receive educational information via mail about non-pharmacological approaches to pain management.
- Feasibility of participant recruitment [ Time Frame: 3 months ]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
- Pain management strategies used - Chronic Pain Coping Inventory [ Time Frame: 3 months ]The chronic pain coping inventory measures the use of pain self-management strategies (e.g., activity pacing)
- Pain management strategies used - Self-reported use of pain management strategies [ Time Frame: 3 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707886
|United States, Connecticut|
|Va Connecticut Healthcare System|
|West Haven, Connecticut, United States, 06516|