Computerized Decision Support Tool for Pain Management in Primary Care

NCT04716621

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Treated at the Institute for Family Health

2. Spoke English or Spanish

3. Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months

4. Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).

5. Willingness to complete questionnaires three times

6. A commitment to return to the practice

7. Reachable by phone

8. No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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Advanced Information
Descriptive Information
Brief Title  ICMJE Computerized Decision Support Tool for Pain Management in Primary Care
Official Title  ICMJE Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
Brief Summary

Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care.

The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.

Detailed Description This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Other: Early intervention
    The Pain Management Support System for Primary Care (PMSS-PC) generated "best practice alerts" and gave clinicians access to a pain assessment template, measures of psychological distress and substance use, guidelines for drug and non-drug therapies, and facilitated referrals. At implementation, clinicians at the practices were offered in-person and virtual education through six webinars on best practices for pain.
  • Other: Delayed intervention
    Delayed wait-list control group. The second arm involved three additional sites receiving the PMSS-PC intervention 6 months after the first arm. Initial outcomes from the PMSS-PC Experimental Intervention arm were compared to those of this Wait-list Control arm.
Study Arms  ICMJE
  • Experimental: Early intervention
    Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.
    Intervention: Other: Early intervention
  • Delayed intervention
    Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.
    Intervention: Other: Delayed intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2021)
528
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Treated at the Institute for Family Health
  2. Spoke English or Spanish
  3. Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
  4. Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).
  5. Willingness to complete questionnaires three times
  6. A commitment to return to the practice
  7. Reachable by phone
  8. No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments

Exclusion Criteria:

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Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04716621
Other Study ID Numbers  ICMJE 8408357
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MJHS Institute for Innovation in Palliative Care
Study Sponsor  ICMJE MJHS Institute for Innovation in Palliative Care
Collaborators  ICMJE
  • Pfizer
  • The Institute for Family Health
Investigators  ICMJE Not Provided
PRS Account MJHS Institute for Innovation in Palliative Care
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP