Effects of a Patient Driven Assessment Process With Complex Pain Patients

Chronic Pain Clinical Trial

— PDAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746354
• Other study ID #: Pro00003197
• Status: Completed
• Phase: N/A
• First received: April 14, 2016
• Last updated: April 20, 2016
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• The MySupport tool
Utilization of the MySupport tool, a tailored patient-centered assessment

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of sleep	Insomnia Severity Index	Change at 5 months, change from 5 to10 months and change at 10 months	No
Secondary	Patient skill in managing health care	Patient Activation Measure	Change at 5 months, change from 5 to10 months and change at 10 months	No
Secondary	Health-related quality of life	EuroQuol Instrument	Change at 5 months, change from 5 to10 months and change at 10 months	No
Secondary	Clinician empathy	CARE measure	Change at 5 months, change from 5 to10 months and change at 10 months	No
Secondary	Self-care practices	Questionnaire	Change at 5 months, change from 5 to10 months and change at 10 months	No
Secondary	Health services utilization	Electronic medical records	Change at 5 months, change from 5 to10 months and change at 10 months	No