Effects of a Patient Driven Assessment Process With Complex Pain Patients

NCT02746354 | Completed

• 1 other identifier: Pro00003197
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic Pain; Analgesics, Opioid; Primary Health Care

Outcome Measures

Primary Outcomes (1)

• Pain severity and functioning

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

  Change at 5 months, change from 5 to10 months and change at 10 months

Secondary Outcomes (6)

• Quality of sleep

  Change at 5 months, change from 5 to10 months and change at 10 months

• Patient skill in managing health care

  Change at 5 months, change from 5 to10 months and change at 10 months

• Health-related quality of life

  Change at 5 months, change from 5 to10 months and change at 10 months

• Clinician empathy

  Change at 5 months, change from 5 to10 months and change at 10 months

• Self-care practices

  Change at 5 months, change from 5 to10 months and change at 10 months

Study Arms (2)

The MySupport tool

EXPERIMENTAL

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

Other: The MySupport tool

Usual care

NO INTERVENTION

Interventions

The MySupport tool OTHER

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

The MySupport tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 21, 2016
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)