NCT05497154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 3, 2022

Last Update Submit

August 2, 2023

Conditions

Keywords

opioid misusephysical therapyphysical therapist

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (10)

  • Thematic analysis from semi-structured interviews

    4 months after the last training session

  • Reach

    Immediate post training

  • Adoption 1- engaging patients in conversations

    Approximately 4 months after last training session

  • +7 more other outcomes

Study Arms (1)

Training Arm

EXPERIMENTAL
Behavioral: Training Arm

Interventions

Training ArmBEHAVIORAL

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.

Training Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related 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.

    PMID: 12085073BACKGROUND
  • 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.

    PMID: 17222274BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Magel, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 11, 2022

Study Start

October 14, 2022

Primary Completion

May 27, 2023

Study Completion

June 8, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 9 months and ending 36 months following article publication
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.

Locations