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Improving the Management of Chronic Pain in Primary Care

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photo-elicitation and online group support
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients will need to meet the following criteria in order to participate in the study:

  • they must be between the ages of 18-75
  • they must have an established care relationship with the practitioner (having had at least two previous visits for chronic pain of at least 6 months' duration)
  • they must read and understand English
  • they must be willing to sign a consent. Patients must have a device to take pictures (e.g., camera, phone, or tablet) and access to the internet in order to complete REDcap (the online data collection tool we will use to capture quantitative data in order to assess intervention impact), and participate in the online discussions via Facebook.

Exclusion Criteria:

  • No terminal illness, and/or a life expectancy of < 1yr.

Sites / Locations

  • University of Missouri, Dept. of Family and Community Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

The intervention uses photo-elicitation and online group support (via Facebook) to improve patients' overall experience of chronic pain and patient-identified areas of function. This intervention was informed by the Photovoice methodology developed by Wang and Burris (1994). Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them in office visits with their physician or mid-level clinician.

Patients in the control practices will receive usual care and will be eligible to participate in the intervention after their participation in the study is completed at 12 months.

Outcomes

Primary Outcome Measures

Change in the score on the 3-item measure of chronic pain (PEG)
The PEG asks 3 questions about (1) severity of pain on average in the past week, (2) how much has pain interfered with your life during the past week, and (3) how much has pain interfered with your general activity.

Secondary Outcome Measures

Change in the score on the Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ is a 10-item questionnaire asking "how confident you are" in performing activities in the specified areas.
Change in the score on the Chronic Pain Acceptance Questionnaire (CPAQ)
We will use 8 of the 20 questions in the CPAQ, which ask about pain acceptance.
Change in score on a scale measuring the patient-centeredness of an office visit (Stewart et al., 2004)
This scale of patient-centeredness asks 14 questions about how patient-centered the office visit was. We will use a subset of the 14 items.

Full Information

First Posted
May 17, 2016
Last Updated
September 11, 2019
Sponsor
University of Missouri-Columbia
Collaborators
American Academy of Family Physicians National Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT02783365
Brief Title
Improving the Management of Chronic Pain in Primary Care
Official Title
Improving the Management of Chronic Pain in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
American Academy of Family Physicians National Research Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There are an estimated 100 million Americans with chronic pain. The enormity of the problem at the societal level is staggering, not simply in terms of its sheer prevalence but also the societal costs, including health care expenditures, disability compensation, lost productivity, and lost employment potential. The pharmacological focus in treatment tends to give patients with chronic pain a negative stereotype as many are viewed as drug seeking, or worse, they are perceived to have an imaginary illness. It is argued that these stigmas not only negatively affect the patients' healthcare experience, but also perpetuate maladaptive coping. In addition, it is suggested that reliance on pharmacological approaches have contributed to the rate of overdoses from prescribed opioids. In order to address this burden facing society, patients need opportunities to foster a sense of self-efficacy to manage their pain, as well as improve their healthcare experience by allowing them to dialogue with their clinician openly and freely about their chronic pain, and coping strategies. This study is designed to explore the impact of an intervention using photo-elicitation (based on Photovoice) and online group support (via Facebook) on participants' overall experience of chronic pain and patient-identified areas of function. Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them. This method serves as an empowering tool to connect participants to key stakeholders in the community, facilitates change and opportunities that otherwise would not be available to marginalized groups.
Detailed Description
This is a multi-site study occurring between the University of Missouri, and the American Academy of Family Physicians National Research Network (NRN). The University of Missouri will be responsible for the following: Coordinating the approval of initial protocol as well as subsequent amendments. Ensure that each site is using the correct version of the protocol. Serve as the study contact. Participate in the selection of qualified sites for participation (the NRN will be responsible for recruitment and randomization. This process will be overseen by MU). Monitor progress and oversee all conduct of the study at participating sites. Responsible for the data analysis, reporting, integrity, and accuracy of data. There will be one protocol document, and each site will utilize this document. The lead site (MU) will develop the informed consent, which includes language that data will be shared with the NRN. The NRN will be the Institutional Review Board (IRB) of record for the 18 practices recruited to participate within the NRN, and will provide a letter of authorization and final IRB approval to the lead PI (MU). The study will test if a photo elicitation intervention combined with access to online community support and a chronic pain guideline can improve a 3-item measure of chronic pain [the PEG score: Pain intensity (P), Enjoyment of Life (E), and General Activity (G)] and a patient-identified area of function, compared to a group who receive the guideline alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention uses photo-elicitation and online group support (via Facebook) to improve patients' overall experience of chronic pain and patient-identified areas of function. This intervention was informed by the Photovoice methodology developed by Wang and Burris (1994). Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them in office visits with their physician or mid-level clinician.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control practices will receive usual care and will be eligible to participate in the intervention after their participation in the study is completed at 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Photo-elicitation and online group support
Intervention Description
See above information.
Primary Outcome Measure Information:
Title
Change in the score on the 3-item measure of chronic pain (PEG)
Description
The PEG asks 3 questions about (1) severity of pain on average in the past week, (2) how much has pain interfered with your life during the past week, and (3) how much has pain interfered with your general activity.
Time Frame
Change from baseline to 12 months after enrollment
Secondary Outcome Measure Information:
Title
Change in the score on the Pain Self-Efficacy Questionnaire (PSEQ)
Description
The PSEQ is a 10-item questionnaire asking "how confident you are" in performing activities in the specified areas.
Time Frame
Change from baseline to 12 months after enrollment
Title
Change in the score on the Chronic Pain Acceptance Questionnaire (CPAQ)
Description
We will use 8 of the 20 questions in the CPAQ, which ask about pain acceptance.
Time Frame
Change from baseline to 12 months after enrollment
Title
Change in score on a scale measuring the patient-centeredness of an office visit (Stewart et al., 2004)
Description
This scale of patient-centeredness asks 14 questions about how patient-centered the office visit was. We will use a subset of the 14 items.
Time Frame
Change from baseline to 12 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will need to meet the following criteria in order to participate in the study: they must be between the ages of 18-75 they must have an established care relationship with the practitioner (having had at least two previous visits for chronic pain of at least 6 months' duration) they must read and understand English they must be willing to sign a consent. Patients must have a device to take pictures (e.g., camera, phone, or tablet) and access to the internet in order to complete REDcap (the online data collection tool we will use to capture quantitative data in order to assess intervention impact), and participate in the online discussions via Facebook. Exclusion Criteria: No terminal illness, and/or a life expectancy of < 1yr.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin H Crenshaw, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri, Dept. of Family and Community Medicine
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will post de-identified data on an open-access website when the study is completed.

Learn more about this trial

Improving the Management of Chronic Pain in Primary Care

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