Difficult Encounters in Pain Medicine

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05585619
• Other study ID #: IRB00334965
• Status: Completed
• Start date: October 10, 2022
• Est. completion date: March 29, 2024

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: March 29, 2024
• Est. primary completion date: December 15, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Pain treatment
Any pain treatment to include medications, procedures, or referrals

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hinchey 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficulty of encounter as rated by trainee	Difficulty of encounter as rated by a 6-point Likert scale (1=very pleasant, 6=extremely difficult)	Immediately after consult
Primary	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)	Immediately after consult
Secondary	Patient global impression of change	1-7 Likert scale (1=no change or worse, 7=a great deal better)	1-2 months post-treatment
Secondary	Pain score	0-10 numerical pain scale (0=no pain, 10= worst pain imaginable)	1-2 months post-treatment
Secondary	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)	1-2 months post-treatment
Secondary	Appointment status	Showed up on time or showed up late or missed appointment	1-2 months post-treatment
Secondary	Number of side effects	Side effects from medications or complications from procedures	1-2 months post-treatment