Clinical trial NCT01838057: Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting
Official title: Evaluation of the Clinical and Economic Impact of Pfizer's painPRIMER Program in the Treatment of Low Back Pain in a Primary Care Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Piedmont Healthcare System
First posted: 2013-04-23
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with low back pain

Brief summary: To evaluate the impact of painPRIMER in a prospective six-month clinical investigation looking at clinical outcomes, health care professional and patient satisfaction, healthcare resource use, productivity and direct and indirect costs. The hypothesis is that early identification of the presence of neuropathic pain and back pain related comorbidities, to direct appropriate pharmacologic and non-pharmacologic treatment, painPRIMER would improve patient outcomes and reduce patient cycling, inappropriate use of imaging and surgery, thereby reducing costs and productivity loss associated with these inefficiencies.


Eligibility criteria: Inclusion Criteria:

* Those aged 18 years of age
* Presenting to a HCP with low back pain
* Able to speak, write, and understand both verbal and written English

Exclusion Criteria:

* Conditions that may impede the patient's ability to participate in painPRIMER and complete the questionnaires, as per the HCP's discretion
* Patients presenting who have undergone surgery for back pain in the previous 12 months

  * Patients with Medicare as their primary insurance

Primary outcomes:
measure: Roland Morris Disability Questionnaire: Change from baseline to month 3 in the Roland Morris Disability Questionnaire (RMDQ) total score in the painPRIMER cohort vs control cohort
timeFrame: 3 month
measure: Low back pain (LBP) Cost: LBP (specific and related) direct medical costs associated with utilization of healthcare incurred by each study patient from baseline to month 6
timeFrame: 6 month
Secondary outcomes:
measure: Change from baseline to month 6 in RMDQ total score
timeFrame: 3 and 6 months
measure: Change from baseline to month 3 and 6 in low back pain intensity (LBPI)
timeFrame: 3 and 6 months
measure: Change from baseline to month 3 and 6 daily sleep interference rating scale (DSIRS)
timeFrame: 3 and 6 months
measure: Response as defined as a the proportion of patients with at least 30% and 50% improvement in LBPI at 3 and 6 months
timeFrame: 3 and 6 months
measure: Response as defined as a the proportion of patients with at least 30% and 50% improvement in RMDQ at 3 and 6 months
timeFrame: 3 and 6 months
measure: Quality of Life in the painPRIMER cohort vs control cohort: Change from baseline to month 3 and 6 in the Short- Form.
timeFrame: 3 and 6 months
measure: psychosocial outcomes in the painPRIMER cohort and control cohort: Proportion of patients at risk for depression and/or anxiety (via Patient Health Questionnaire-4 [PHQ-4]) at baseline, 3 and 6 months
timeFrame: 3 and 6 months
measure: psychosocial outcomes in the painPRIMER cohort and control cohort: Changes from baseline to month 3 and 6 in patients at risk for depression (PHQ-8) and anxiety (GAD-7), among those receiving the instrument (NOTE: only given to those scoring >/=
timeFrame: 3 and 6 months
measure: 3 on PHQ-4)
timeFrame: 3 and 6 months
measure: psychosocial outcomes in the painPRIMER cohort and control cohort: Change from baseline to month 3 and 6 in catastrophizing (Coping Strategies Questionnaire -Catastrophizing [CSQ-CAT])
timeFrame: 3 and 6 months
measure: productivity/indirect costs: Changes from baseline to month 3 and 6 in Work Productivity and Activity Impairment (WPAI): Specific Health Problem, LBP
timeFrame: 3 and 6 months
measure: Direct cost: Comparison of resource use/direct medical costs, in 6 months pre-enrollment/index date and 6 months post-enrollment/index date via insurance claims data for painPRIMER and control cohorts
timeFrame: 3 and 6 months
measure: Patient satisfaction with painPRIMER
timeFrame: 3 and 6 months
measure: Healthcare professional satisfaction with painPRIMER
timeFrame: 6 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: Georgia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: