NCT05585619

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
428

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

October 14, 2022

Last Update Submit

May 9, 2024

Conditions

Keywords

chronic pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Patient global impression of change

    1-2 months post-treatment

  • Pain score

    1-2 months post-treatment

  • Categorical success

    1-2 months post-treatment

  • Appointment status

    1-2 months post-treatment

  • Number of side effects

    1-2 months post-treatment

Study Arms (1)

Chronic pain patients

New chronic pain consults seen by a trainee and attending pain physician

Other: Pain treatment

Interventions

Any pain treatment to include medications, procedures, or referrals

Chronic pain patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic pain patients seen for a new consultation at the Johns Hopkins Blaustein Pain Treatment Center

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • Liu 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.

MeSH Terms

Conditions

Chronic Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Steven P. Cohen, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 19, 2022

Study Start

October 10, 2022

Primary Completion

December 15, 2023

Study Completion

March 29, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Variables studied, outcomes, statistical codes

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
1-3 years after completion of study
Access Criteria
By request

Locations