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Physical Therapists Identifying Patients With Opioid Misuse

Primary Purpose

Opioid Misuse, Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training Arm
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Misuse focused on measuring opioid misuse, physical therapy, physical therapist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • University of Utah physical therapists with at least 0.5 full-time equivalent
  • Self report managing patients with musculoskeletal pain

Exclusion Criteria:

  • None

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training Arm

Arm Description

Outcomes

Primary Outcome Measures

Change in the Drug and Drug Problems Perception Questionnaire (DDPPQ)
The DDPPQ is a 20 item tool used to measure the attitudes of health care providers related to the management of patients misusing drugs and contains 5 subscales (Role Adequacy: 7 items; Role Legitimacy: 2 items; Role Support: 3 items; Role Self-esteem: 4 items; Job Satisfaction: 4 items) Each item is scored on a 7-point scale (1 = strongly agree to 7 = strongly disagree). Each item was modified to asses the health care providers' attitudes about managing patients with opioid misuse.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2022
Last Updated
August 2, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05497154
Brief Title
Physical Therapists Identifying Patients With Opioid Misuse
Official Title
Physical Therapists Identifying Patients With Opioid Misuse
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
May 27, 2023 (Actual)
Study Completion Date
June 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

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 purpose of this study is to develop and operationalize key procedures for physical therapists (n = 12) to address patients who are at risk for or have opioid misuse (OM). The investigators will train physical therapists in procedures to: 1) engage patients at risk for OM in conversations about appropriate opioid use, 2) screen and 3) assess these patients for OM and, 4) refer patients for further treatment if OM is suspected. The investigators will employ a modified Delphi approach to iteratively refine and operationalize the procedures and to arrive at a finalized procedure manual followed by an evaluation of the implementation of these procedures.
Detailed Description
The purpose of this study is to develop and operationalize key procedures for physical therapists (n = 12) to address patients who are at risk for or have OM. The investigators will train physical therapists in procedures to: 1) engage patients at risk for OM in conversations about appropriate opioid use, 2) screen and 3) assess these patients for OM and, 4) refer patients for further treatment if OM is suspected. The investigators will employ a modified Delphi approach to iteratively refine and operationalize the procedures and to arrive at a finalized procedure manual followed by an evaluation of the implementation of these procedures. Approximately 4 months following the development of the manual and the distribution of the finalized manual, the investigators will conduct semi-structured interviews to determine the barriers and facilitators to implementing the procedures learned in the training. Our aims are: Qualitatively evaluate physical therapists' perceptions and recommendations for implementing OM procedures. Evaluate the implementation of the manualized OM procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Misuse, Musculoskeletal Pain
Keywords
opioid misuse, physical therapy, physical therapist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Training Arm
Intervention Description
The training will be composed of 4 separate training sessions provided every 2 - 4 weeks. During the 1st session (45 minutes), the investigators will educate the physical therapist about the different categories of opioid use including opioid misuse (OM) and the risks associated with OM as well as training to engage the patient in a conversation about opioid use. The 2nd and 3rd sessions (30 minutes each) involve training in procedures to screen and assess patients at risk for OM, respectively. The 4th session (30 minutes) involves training in procedures to refer patients to a specialist or a primary care provider for further treatment if OM is suspected.
Primary Outcome Measure Information:
Title
Change in the Drug and Drug Problems Perception Questionnaire (DDPPQ)
Description
The DDPPQ is a 20 item tool used to measure the attitudes of health care providers related to the management of patients misusing drugs and contains 5 subscales (Role Adequacy: 7 items; Role Legitimacy: 2 items; Role Support: 3 items; Role Self-esteem: 4 items; Job Satisfaction: 4 items) Each item is scored on a 7-point scale (1 = strongly agree to 7 = strongly disagree). Each item was modified to asses the health care providers' attitudes about managing patients with opioid misuse.
Time Frame
Baseline, immediate post training, 4 months after last training session
Other Pre-specified Outcome Measures:
Title
Thematic analysis from semi-structured interviews
Description
Semi-structured interviews to assess barriers and facilitators of implementing the procedures learned in the training
Time Frame
4 months after the last training session
Title
Reach
Description
Proportion of physical therapists who agreed to attend the training that attended all training sessions
Time Frame
Immediate post training
Title
Adoption 1- engaging patients in conversations
Description
Percentage of physical therapists who attended the training that report engaging patients in conversations about opioid misuse,
Time Frame
Approximately 4 months after last training session
Title
Adoption 2 - screening
Description
Percentage of physical therapists who attended the training that report screening for opioid misuse
Time Frame
Approximately 4 months after last training session
Title
Adoption 3 - assessing
Description
Percentage of physical therapists who attended the training that report assessing patients for opioid misuse
Time Frame
Approximately 4 months after last training session
Title
Adoption 4 - referring
Description
Percentage of physical therapists who attended the training that report referring for opioid misuse
Time Frame
Approximately 4 months after last training session
Title
Qualitative thematic analysis of each focus group
Description
The investigators will conduct focus groups after each training session. All sessions will be analyzed together to qualitatively assess the physical therapists' receptivity to the procedures learned in the training sessions.
Time Frame
Immediately after each of the 4 training sessions.
Title
Change in the Frequency of opioid misuse management practices - Adapted from the Alcohol Education Survey
Description
Questions were adapted: "How often do you ask patients about alcohol problems?" was modified to: "How often do you ask patients about problems with prescription opioid medication misuse? 4 additional questions were similarly modified ([1] How often do you formally screen patients for prescription opioid medication misuse using screening instruments, such as the Current Opioid Misuse Measure or other tools; [2] How often do you assess patients' readiness to change their prescription opioid medication misuse behaviors?; [3] How often do you discuss/advise patients to change their prescription opioid medication misuse behaviors?; [4] How often do you refer patients with prescription opioid medication misuse for further assessments or interventions?). Scoring: Never, Rarely (less than 10% of the time), Occasionally (about 30% of the time), Sometimes (about 50% of the time), Frequently (about 70% of the time), Usually (about 90% of the time), Every time.
Time Frame
Baseline, immediately post training and to approximately 4 months after the last training session
Title
Manual of procedures
Description
At the end of the study after the individual interviews, the investigators will finalize the manual of opioid misuse procedures for physical therapists.
Time Frame
Approximately 4 months after the last training session.
Title
Change in the Confidence in opioid misuse management practices. Adapted from the Alcohol Education Survey
Description
These questions were adapted from a survey developed to improve health care providers' management of patients with alcohol problems. The questions are: ([1] I am confident in my ability to ask patients about prescription opioid medication misuse, [2] I am confident in my ability to formally screen patients for prescription opioid medication misuse using screening instruments, such as the Current Opioid Misuse Measure or other tools; [3] I am confident in my ability to assess patients' readiness to change their prescription opioid medication misuse behaviors; [4] I am confident in my ability to discuss/advise patients to change their prescription opioid medication misuse behaviors; [5] I am confident in my ability to refer patients with prescription opioid medication misuse for further assessments or interventions?). Each confidence with management practice question was scored on a 7-point Likert scale (1 = no confidence; 7 = high confidence).
Time Frame
Baseline, immediately post training and to approximately 4 months after the last training session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: University of Utah physical therapists with at least 0.5 full-time equivalent Self report managing patients with musculoskeletal pain Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Magel, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data to be shared: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). What documents will be available: Study protocol, statistical analysis plan, Analytic code. With whom will the data be shared: Researchers who provide a methodologically sound proposal For what type of analyses: To achieve the aims in approved proposal
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
By what mechanism will data be made available: Proposal should be directed to Jake.Magel@hsc.utah.edu to gain access, data requestors will need to sign a data access agreement. Link to data will be provided.
Citations:
PubMed Identifier
12085073
Citation
D'Onofrio G, Nadel ES, Degutis LC, Sullivan LM, Casper K, Bernstein E, Samet JH. Improving emergency medicine residents' approach to patients with alcohol problems: a controlled educational trial. Ann Emerg Med. 2002 Jul;40(1):50-62. doi: 10.1067/mem.2002.123693.
Results Reference
background
PubMed Identifier
17222274
Citation
Watson H, Maclaren W, Kerr S. Staff attitudes towards working with drug users: development of the Drug Problems Perceptions Questionnaire. Addiction. 2007 Feb;102(2):206-15. doi: 10.1111/j.1360-0443.2006.01686.x.
Results Reference
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Physical Therapists Identifying Patients With Opioid Misuse

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