Computerized Decision Support Tool for Pain Management in Primary Care

NCT ID: NCT04716621

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-11

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Early intervention

Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.

Group Type EXPERIMENTAL

Early intervention

Intervention Type OTHER

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.

Delayed intervention

Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.

Group Type OTHER

Delayed intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

The Institute for Family Health

OTHER

Sponsor Role collaborator

MJHS Institute for Innovation in Palliative Care

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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8408357

Identifier Type: -

Identifier Source: org_study_id

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