Pain SMART: Shared Medical Appointments to Refocus Treatment

October 14, 2018 updated by: VA Connecticut Healthcare System
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Connecticut Healthcare System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VISN1 Career Development Award Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02103-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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