Chronic PainNCT05585619
Difficult Encounters in Pain Medicine
An observational study of Chronic Pain, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators are seeking to determine factors associated with difficult patient encounters in an academic pain clinic. The investigators are examining 36 different variables to determine the association with "difficult" patient encounters as independently rated by a trainee and attending physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain treatment
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 29 Mar 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Chronic pain patients seen for a new consultation at the Johns Hopkins Blaustein Pain Treatment Center
Who may be able to join
- ≥ 18 years of age
- Pain duration > 3 months
- New Visit (or no visit within 3 years)
Who cannot join
- Referral only for diagnostic procedure
- Friend or relative, or direct referral from friend or relative
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Difficult Encounters in a Chronic Pain Setting: An Analysis of Factors Associated With "Difficult"
The investigators are seeking to determine factors associated with difficult patient encounters in an academic pain clinic. The investigators are examining 36 different variables to determine the association with "difficult" patient encounters as independently rated by a trainee and attending physician.
Read the detailed description
Pain is associated with significant psychosocial pathology include axis 1 diagnoses, opioid use and misuse, unemployment, and strained relationships, and treatments for chronic pain are often ineffective. Collectively, these factors may result in a higher prevalence of patients characterized as 'difficult', which can lead to missed diagnoses, barriers to care resulting in poorer outcomes (professional pessimism, mistrust, passive treatment, referrals to other providers or discharge), patient complaints and 'HERO' events, avoidable legal claims, and increased risk of professional burnout. Characterizing patients as "difficult" (instead of encounters) may have negative consequences for future care, and there are few studies that have explored patients' perspectives on "difficult" encounters. Although several articles have narratively explored this issue, there are few targeted at chronic pain patients, and no studies in this population that set out to determine what variables are associated with a "difficult encounter", the congruence between patients' and providers' impressions of an encounter, or whether difficult encounters are associated with pain treatment outcome.
- Conditions
- Chronic Pain
- Being tested
- Pain treatment
- Keywords
- chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain treatmentOther
Any pain treatment to include medications, procedures, or referrals
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients | New chronic pain consults seen by a trainee and attending pain physician Receives: Other: Pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty of encounter as rated by trainee
Difficulty of encounter as rated by a 6-point Likert scale (1=very pleasant, 6=extremely difficult)
Measured: Immediately after consult
Difficulty of encounter as rated by attending physician
Difficulty of encounter as rated by a 6-point Likert scale (1=very pleasant, 6=extremely difficult)
Measured: Immediately after consult
Secondary outcomes (5)
Patient global impression of change
1-7 Likert scale (1=no change or worse, 7=a great deal better)
Measured: 1-2 months post-treatment
Pain score
0-10 numerical pain scale (0=no pain, 10= worst pain imaginable)
Measured: 1-2 months post-treatment
Categorical success
Binary measure of success (2-point or greater decrease in average pain score coupled with a score of 5 or greater on Patient global impression of change scale)
Measured: 1-2 months post-treatment
Appointment status
Showed up on time or showed up late or missed appointment
Measured: 1-2 months post-treatment
Number of side effects
Side effects from medications or complications from procedures
Measured: 1-2 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start10 Oct 2022
- Primary completion15 Dec 2023
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven P. Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585619
- Sponsor's protocol ID
- IRB00334965
- Status last verified
- May 2024
- First submitted
- 14 Oct 2022
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Variables studied, outcomes, statistical codes
Publications
Wasan AD, Wootton J, Jamison RN. Dealing with difficult patients in your pain practice. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):184-92. doi: 10.1016/j.rapm.2004.11.005.
PubMed 15765460Hinchey SA, Jackson JL. A cohort study assessing difficult patient encounters in a walk-in primary care clinic, predictors and outcomes. J Gen Intern Med. 2011 Jun;26(6):588-94. doi: 10.1007/s11606-010-1620-6. Epub 2011 Jan 25.
PubMed 21264521Liu WL, van Gelderen E, Mawalkar R, Wang EJ, Treisman G, Cohen SP. Do difficult encounters affect pain treatment outcomes? A prospective cohort study. Pain Med. 2025 Sep 1;26(9):554-561. doi: 10.1093/pm/pnaf027.
PubMed 40100641
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficult Encounters in a Chronic Pain Setting: An Analysis of Factors Associated With "Difficult"
- ClinicalTrials.gov ID
- NCT05585619
- Acronym / sponsor ID
- IRB00334965
- Conditions
- Chronic Pain
- Keywords
- chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 19 Oct 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 investigators are seeking to determine factors associated with difficult patient encounters in an academic pain clinic. The investigators are examining 36 different variables to determine the association with "difficult" patient encounters as independently rated by a trainee and attending physician.
Detailed description
Pain is associated with significant psychosocial pathology include axis 1 diagnoses, opioid use and misuse, unemployment, and strained relationships, and treatments for chronic pain are often ineffective. Collectively, these factors may result in a higher prevalence of patients characterized as 'difficult', which can lead to missed diagnoses, barriers to care resulting in poorer outcomes (professional pessimism, mistrust, passive treatment, referrals to other providers or discharge), patient complaints and 'HERO' events, avoidable legal claims, and increased risk of professional burnout. Characterizing patients as "difficult" (instead of encounters) may have negative consequences for future care, and there are few studies that have explored patients' perspectives on "difficult" encounters. Although several articles have narratively explored this issue, there are few targeted at chronic pain patients, and no studies in this population that set out to determine what variables are associated with a "difficult encounter", the congruence between patients' and providers' impressions of an encounter, or whether difficult encounters are associated with pain treatment outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients | – | Other: Pain treatmentNew chronic pain consults seen by a trainee and attending pain physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic pain patients seen for a new consultation at the Johns Hopkins Blaustein Pain Treatment Center
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Pain duration > 3 months
- New Visit (or no visit within 3 years)
Key exclusion criteria (2 listed)
- Referral only for diagnostic procedure
- Friend or relative, or direct referral from friend or relative
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 |
|---|---|---|
| Pain treatmentAny pain treatment to include medications, procedures, or referrals | Other | Chronic pain patients |
Primary outcome
Difficulty of encounter as rated by trainee
Time frame: Immediately after consult
Difficulty of encounter as rated by a 6-point Likert scale (1=very pleasant, 6=extremely difficult)
Difficulty of encounter as rated by attending physician
Time frame: Immediately after consult
Difficulty of encounter as rated by a 6-point Likert scale (1=very pleasant, 6=extremely difficult)
5 secondary outcomes
Patient global impression of change
Time frame: 1-2 months post-treatment
Pain score
Time frame: 1-2 months post-treatment
Categorical success
Time frame: 1-2 months post-treatment
Appointment status
Time frame: 1-2 months post-treatment
Number of side effects
Time frame: 1-2 months post-treatment
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 10 May 2024.
- Results publication: PubMed 15765460Wasan AD, Wootton J, Jamison RN. Dealing with difficult patients in your pain practice. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):184-92. doi: 10.1016/j.rapm.2004.11.005.
- Results publication: PubMed 21264521Hinchey SA, Jackson JL. A cohort study assessing difficult patient encounters in a walk-in primary care clinic, predictors and outcomes. J Gen Intern Med. 2011 Jun;26(6):588-94. doi: 10.1007/s11606-010-1620-6. Epub 2011 Jan 25.
- Derived from this study: PubMed 40100641Liu WL, van Gelderen E, Mawalkar R, Wang EJ, Treisman G, Cohen SP. Do difficult encounters affect pain treatment outcomes? A prospective cohort study. Pain Med. 2025 Sep 1;26(9):554-561. doi: 10.1093/pm/pnaf027.
- Individual participant dataSharing planned: Yes. Variables studied, outcomes, statistical codes
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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.
Steven P. Cohen, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Johns Hopkins University 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 3 inclusion and 2 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 10 May 2024. 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?
Difficulty of encounter as rated by trainee (time frame: Immediately after consult). The study lists 2 primary outcomes in all. 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 NCT05585619, which also lists 3 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 10 May 2024.