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OpenTrials
Completed

NCT Number: NCT05585619

Difficult Encounters in Pain Medicine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age
  • Pain duration > 3 months
  • New Visit (or no visit within 3 years)

Exclusion criteria

  • Referral only for diagnostic procedure
  • Friend or relative, or direct referral from friend or relative

Treatment and study plan

Pain treatment

Other

Any pain treatment to include medications, procedures, or referrals

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Patient global impression of change

    Time frame: 1-2 months post-treatment

    1-7 Likert scale (1=no change or worse, 7=a great deal better)

  2. Pain score

    Time frame: 1-2 months post-treatment

    0-10 numerical pain scale (0=no pain, 10= worst pain imaginable)

  3. Categorical success

    Time frame: 1-2 months post-treatment

    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)

  4. Appointment status

    Time frame: 1-2 months post-treatment

    Showed up on time or showed up late or missed appointment

  5. Number of side effects

    Time frame: 1-2 months post-treatment

    Side effects from medications or complications from procedures

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Difficult Encounters in a Chronic Pain Setting: An Analysis of Factors Associated With "Difficult"

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 19, 2022
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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