Viewing Study NCT02783365



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Last Modification Date: 2024-10-26 @ 12:03 PM
Study NCT ID: NCT02783365
Status: COMPLETED
Last Update Posted: 2019-09-13
First Post: 2016-05-17

Brief Title: Improving the Management of Chronic Pain in Primary Care
Sponsor: University of Missouri-Columbia
Organization: University of Missouri-Columbia

Study Overview

Official Title: Improving the Management of Chronic Pain in Primary Care
Status: COMPLETED
Status Verified Date: 2019-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None