Clinical trial NCT02746354: Effects of a Patient Driven Assessment Process With Complex Pain Patients
Official title: Effects of a Patient Driven Assessment Process With Complex Pain Patients (PDAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Analgesics, Opioid
Primary Health Care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain severity and functioning
timeFrame: Change at 5 months, change from 5 to10 months and change at 10 months
Secondary outcomes:
measure: Quality of sleep
timeFrame: Change at 5 months, change from 5 to10 months and change at 10 months
measure: Patient skill in managing health care
timeFrame: Change at 5 months, change from 5 to10 months and change at 10 months
measure: Health-related quality of life
timeFrame: Change at 5 months, change from 5 to10 months and change at 10 months
measure: Clinician empathy
timeFrame: Change at 5 months, change from 5 to10 months and change at 10 months
measure: Self-care practices
timeFrame: Change at 5 months, change from 5 to10 months and change at 10 months
measure: Health services utilization
timeFrame: Change at 5 months, change from 5 to10 months and change at 10 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
References: