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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05497154
Other study ID # 3394
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2022
Est. completion date June 8, 2023

Study information

Verified date August 2023
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. Qualitatively evaluate physical therapists' perceptions and recommendations for implementing OM procedures. 2. Evaluate the implementation of the manualized OM procedures.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 8, 2023
Est. primary completion date May 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Training Arm
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.

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Thematic analysis from semi-structured interviews Semi-structured interviews to assess barriers and facilitators of implementing the procedures learned in the training 4 months after the last training session
Other Reach Proportion of physical therapists who agreed to attend the training that attended all training sessions Immediate post training
Other Adoption 1- engaging patients in conversations Percentage of physical therapists who attended the training that report engaging patients in conversations about opioid misuse, Approximately 4 months after last training session
Other Adoption 2 - screening Percentage of physical therapists who attended the training that report screening for opioid misuse Approximately 4 months after last training session
Other Adoption 3 - assessing Percentage of physical therapists who attended the training that report assessing patients for opioid misuse Approximately 4 months after last training session
Other Adoption 4 - referring Percentage of physical therapists who attended the training that report referring for opioid misuse Approximately 4 months after last training session
Other Qualitative thematic analysis of each focus group 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. Immediately after each of the 4 training sessions.
Other Change in the Frequency of opioid misuse management practices - Adapted from the Alcohol Education Survey 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. Baseline, immediately post training and to approximately 4 months after the last training session
Other Manual of procedures At the end of the study after the individual interviews, the investigators will finalize the manual of opioid misuse procedures for physical therapists. Approximately 4 months after the last training session.
Other Change in the Confidence in opioid misuse management practices. Adapted from the Alcohol Education Survey 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). Baseline, immediately post training and to approximately 4 months after the last training session
Primary 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. Baseline, immediate post training, 4 months after last training session
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