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

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT02746354

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Other: The MySupport tool	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The MySupport tool Utilization of the MySupport tool, a tailored patient-centered assessment	Other: The MySupport tool Utilization of the MySupport tool, a tailored patient-centered assessment
No Intervention: Usual care

Arm

Intervention/Treatment

Experimental: The MySupport tool

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

Other: The MySupport tool

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

No Intervention: Usual care

Outcome Measures

Primary Outcome Measures

Pain severity and functioning [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 Outcome Measures

Quality of sleep [Change at 5 months, change from 5 to10 months and change at 10 months]
Insomnia Severity Index
Patient skill in managing health care [Change at 5 months, change from 5 to10 months and change at 10 months]
Patient Activation Measure
Health-related quality of life [Change at 5 months, change from 5 to10 months and change at 10 months]
EuroQuol Instrument
Clinician empathy [Change at 5 months, change from 5 to10 months and change at 10 months]
CARE measure
Self-care practices [Change at 5 months, change from 5 to10 months and change at 10 months]
Questionnaire
Health services utilization [Change at 5 months, change from 5 to10 months and change at 10 months]
Electronic medical records

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Center for Health Research	Portland	Oregon	United States	97227

Sponsors and Collaborators

Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT02746354

Other Study ID Numbers:

Pro00003197

First Posted:

Apr 21, 2016

Last Update Posted:

Apr 21, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Kaiser Permanente

Chronic Pain

Analgesics, Opioid

Primary Health Care

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Apr 21, 2016