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OpenTrials
Completed

NCT Number: NCT02746354

Effects of a Patient Driven Assessment Process With Complex Pain Patients

The objective of this study is to engage patients with chronic pain and other key stakeholders in an iterative process of pilot-testing a validated patient generated instrument, the Measure Yourself Medical Outcome Profile (MYMOP), to support primary care encounters and provide a direct comparison between a strategy of incorporating patient reported outcomes into the package of care for complex pain patients and usual care. The specific aims of this phase of the project are to: 1) adapt the MYMOP for use in the primary care setting well-integrated into everyday practice flow, and 2) evaluate whether the utilization of the MYMOP data in routine primary care encounters results in improvements in patient symptoms and functioning over time as well as increased satisfaction with the visit for patients and primary care providers. To achieve Aim 2, the investigators will compare the reported outcomes and health care utilization from participating patients in this study for whom the MYMOP-based instrument will be used in routine clinical care to a matched group of chronic pain patients who will not receive the MYMOP-based assessment but will otherwise have similarly collected data. This also allows us to evaluate of the extent to which use of the tool adds patient-centered information to more conventional instruments. In addition to these two aims, for a third aim, the investigators plan to collect qualitative data from patients, their family members, Kaiser Permanente Northwest (KPNW) health care providers, and KPNW administrators to better understand the needs of this subpopulation of patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Kaiser Permanente Northwest health plan members with at least 12 months of continuous eligibility at time of study entry and receive primary care from participating physicians
  • Continued opioid use during the previous 6 months, as defined by 2 or more dispenses of long-acting opioids and/or a minimum cumulative supply of 90 days' worth of short-acting opioids based on electronic medical record (EMR) d) EMR recorded diagnosis of nonspecific chronic pain, Fibromyalgia, or diagnosis of ≥ 2 types of pain in the past year

Exclusion criteria

  • Active cancer
  • Substance abuse or dependence
  • Hospice care
  • Severe mental illness

Treatment and study plan

The MySupport tool

Other

Utilization of the MySupport tool, a tailored patient-centered assessment

Primary outcomes

  1. Pain severity and functioning

    Time frame: Change at 5 months, change from 5 to10 months and change at 10 months

    Brief Pain Inventory (BPI-SF): pain severity and pain interference subscales

Secondary outcomes

  1. Quality of sleep

    Time frame: Change at 5 months, change from 5 to10 months and change at 10 months

    Insomnia Severity Index

  2. Patient skill in managing health care

    Time frame: Change at 5 months, change from 5 to10 months and change at 10 months

    Patient Activation Measure

  3. Health-related quality of life

    Time frame: Change at 5 months, change from 5 to10 months and change at 10 months

    EuroQuol Instrument

  4. Clinician empathy

    Time frame: Change at 5 months, change from 5 to10 months and change at 10 months

    CARE measure

  5. Self-care practices

    Time frame: Change at 5 months, change from 5 to10 months and change at 10 months

    Questionnaire

  6. Health services utilization

    Time frame: Change at 5 months, change from 5 to10 months and change at 10 months

    Electronic medical records

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Effects of a Patient Driven Assessment Process With Complex Pain Patients (PDAP)

Acronym: PDAP

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 21, 2016
Registry last updated
Apr 21, 2016

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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