Opioid MisuseNCT05497154
Physical Therapists Identifying Patients With Opioid Misuse
A study testing Training Arm in people with Opioid Misuse and Musculoskeletal Pain, run by University of Utah at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Misuse, Musculoskeletal Pain
- What is being tested?
- Training Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2022to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Utah physical therapists with at least 0.5 full-time equivalent
- Self report managing patients with musculoskeletal pain
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Opioid Misuse, Musculoskeletal Pain
- Being tested
- Training Arm
- Keywords
- opioid misuse, physical therapy, physical therapist
- Medical subject headings
- Opioid-Related Disorders, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training ArmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Arm | Experimental | Not described Receives: Behavioral: Training Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediate post training, 4 months after last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start14 Oct 2022
- Primary completion27 May 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid MisuseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jake Magel, University of Utah
- Investigators
- John Magel, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497154
- Sponsor's protocol ID
- 3394
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 12085073Watson 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.
PubMed 17222274
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapists Identifying Patients With Opioid Misuse
- ClinicalTrials.gov ID
- NCT05497154
- Acronym / sponsor ID
- 3394
- Conditions
- Opioid Misuse, Musculoskeletal Pain
- Keywords
- opioid misuse, physical therapy, physical therapist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 27 May 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Arm | Experimental | Behavioral: Training Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- University of Utah physical therapists with at least 0.5 full-time equivalent
- Self report managing patients with musculoskeletal pain
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training ArmThe 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. | Behavioural | Training Arm |
Primary outcome
Change in the Drug and Drug Problems Perception Questionnaire (DDPPQ)
Time frame: Baseline, immediate post training, 4 months after last training session
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Background: PubMed 12085073D'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.
- Background: PubMed 17222274Watson 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.
- Individual participant dataSharing planned: Yes. 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
Related trials for Opioid Misuse
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MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
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Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
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The ENHANCE Project Toolkit
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Recruiting
Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Magel, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Arm in people with Opioid Misuse and Musculoskeletal Pain, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Drug and Drug Problems Perception Questionnaire (DDPPQ) (time frame: Baseline, immediate post training, 4 months after last training session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497154, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.