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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The MySupport tool
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring Chronic Pain, Analgesics, Opioid, Primary Health Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Center for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The MySupport tool

Usual care

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of sleep
Insomnia Severity Index
Patient skill in managing health care
Patient Activation Measure
Health-related quality of life
EuroQuol Instrument
Clinician empathy
CARE measure
Self-care practices
Questionnaire
Health services utilization
Electronic medical records

Full Information

First Posted
April 14, 2016
Last Updated
April 20, 2016
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02746354
Brief Title
Effects of a Patient Driven Assessment Process With Complex Pain Patients
Acronym
PDAP
Official Title
Effects of a Patient Driven Assessment Process With Complex Pain Patients (PDAP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Analgesics, Opioid, Primary Health Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The MySupport tool
Arm Type
Experimental
Arm Description
Utilization of the MySupport tool, a tailored patient-centered assessment
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
The MySupport tool
Intervention Description
Utilization of the MySupport tool, a tailored patient-centered assessment
Primary Outcome Measure Information:
Title
Pain severity and functioning
Description
Brief Pain Inventory (BPI-SF): pain severity and pain interference subscales
Time Frame
Change at 5 months, change from 5 to10 months and change at 10 months
Secondary Outcome Measure Information:
Title
Quality of sleep
Description
Insomnia Severity Index
Time Frame
Change at 5 months, change from 5 to10 months and change at 10 months
Title
Patient skill in managing health care
Description
Patient Activation Measure
Time Frame
Change at 5 months, change from 5 to10 months and change at 10 months
Title
Health-related quality of life
Description
EuroQuol Instrument
Time Frame
Change at 5 months, change from 5 to10 months and change at 10 months
Title
Clinician empathy
Description
CARE measure
Time Frame
Change at 5 months, change from 5 to10 months and change at 10 months
Title
Self-care practices
Description
Questionnaire
Time Frame
Change at 5 months, change from 5 to10 months and change at 10 months
Title
Health services utilization
Description
Electronic medical records
Time Frame
Change at 5 months, change from 5 to10 months and change at 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Patient Driven Assessment Process With Complex Pain Patients

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