Chronic Noncancer PainI-PRONCT02188667
Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care
A study testing Providers of Novel Care in people with Chronic Noncancer Pain, run by University of Florida at 4 sites in United States.
Trial summary
The purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Noncancer Pain
- What is being tested?
- Providers of Novel Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Providers at one of six active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
- Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional providing primary care services
Who cannot join
- Residents or other trainees at one of four active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Family Medicine at Hampton Oaks
Gainesville, Florida, 32607
Family Medicine at Haile Plantation
Gainesville, Florida, 32608
Eastside Community Practice
Gainesville, Florida, 32641
Family Medicine at Jonesville
Gainesville, Florida, 32669
About this study
Official title: An Integrative and Sustainable Approach to Pain Management in Primary Care
The purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization.
Read the detailed description
The initiative has three components to aid clinicians' care of patients with chronic noncancer pain: (1) education, (2) standardized patient reported outcomes data collection, and (3) evidence-based brief treatment reminders. Practices will be randomized to either receive the three novel components (treatment group) or continue with usual care (control group).
Providers in the treatment group will be asked (a) to complete a series of six online education modules in pain care, (b) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (c) asked to review this data and related care recommendations during the patient visit, and (d) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Primary study outcomes include comparison of treatment and control group provider and patient satisfaction surveys. Secondary outcome measures include provider referral rates, patient outcomes, patient treatments recommended/ordered, and patient service utilization/costs.
- Conditions
- Chronic Noncancer Pain
- Being tested
- Providers of Novel Care, Providers of Usual Care
- Keywords
- Chronic Noncancer Pain, Musculoskeletal Pain, Neuropathic Pain, Headache Pain
- Medical subject headings
- Musculoskeletal Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providers of Novel CareOther
Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Providers of Usual CareOther
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
| Study group | Role | What they receive |
|---|---|---|
| Providers of Novel Care | Active comparator | Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. Receives: Other: Providers of Novel Care |
| Providers of Usual Care | Sham comparator | Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. Receives: Other: Providers of Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Satisfaction Survey
This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain. Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015). Provider satisfaction data for both the treatment and control groups will be compared.
Measured: Up to 15 months
Patient Satisfaction Survey
This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit. Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015). Patient satisfaction data for both the treatment and control groups will be compared.
Measured: Up to 15 months
Secondary outcomes (7)
Hospital Readmission Rates
The data will be collected retrospectively for a history of hospital readmission rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Measured: Up to 5 years
Lab Orders and Results
The data will be collected retrospectively for a history of lab orders and results (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data will be
Measured: Up to 5 years
Prescribed and Dispensed Medications
The data will be collected retrospectively for a history of prescribed and dispensed medications (June 2011 - June 2015). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Measured: Up to 5 years
Pain Intensity
The data will be collected retrospectively for a history of pain intensity (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Measured: Up to 5 years
Medical Costs
The data will be collected retrospectively for a history of medical costs (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.This will include cost of pain related care for charge amounts and billed amounts for specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.
Measured: Up to 5 years
Health Care Utilization
The data will be collected retrospectively for a history of health care utilization (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. This will include utilization of specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.
Measured: Up to 5 years
Pain Specialist Referral Rates
The data will be collected retrospectively for a history of pain specialist referral rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Noncancer PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Christopher A Harle, PhD, Principal investigator, University of FloridaRobert W Hurley, MD, PhD, Principal investigator, University of FloridaNicole Marlow, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188667
- Sponsor's protocol ID
- IRB201300433
- Other IDs
- 8578749
- Acronym
- I-PRO
- Status last verified
- Mar 2016
- First submitted
- 7 Jul 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative and Sustainable Approach to Pain Management in Primary Care
- ClinicalTrials.gov ID
- NCT02188667
- Acronym / sponsor ID
- I-PRO / IRB201300433
- Conditions
- Chronic Noncancer Pain
- Keywords
- Chronic Noncancer Pain, Musculoskeletal Pain, Neuropathic Pain, Headache Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization.
Detailed description
The initiative has three components to aid clinicians' care of patients with chronic noncancer pain: (1) education, (2) standardized patient reported outcomes data collection, and (3) evidence-based brief treatment reminders. Practices will be randomized to either receive the three novel components (treatment group) or continue with usual care (control group).
Providers in the treatment group will be asked (a) to complete a series of six online education modules in pain care, (b) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (c) asked to review this data and related care recommendations during the patient visit, and (d) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Primary study outcomes include comparison of treatment and control group provider and patient satisfaction surveys. Secondary outcome measures include provider referral rates, patient outcomes, patient treatments recommended/ordered, and patient service utilization/costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Providers of Novel Care | Active comparator | Other: Providers of Novel CareProviders in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. |
| Providers of Usual Care | Sham comparator | Other: Providers of Usual CareProviders in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Providers at one of six active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
- Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional providing primary care services
Key exclusion criteria (1 listed)
- Residents or other trainees at one of four active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Providers of Novel CareProviders in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. | Other | Providers of Novel Care |
| Providers of Usual CareProviders in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. | Other | Providers of Usual Care |
Primary outcome
Provider Satisfaction Survey
Time frame: Up to 15 months
This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain. Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015). Provider satisfaction data for both the treatment and control groups will be compared.
Patient Satisfaction Survey
Time frame: Up to 15 months
This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit. Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015). Patient satisfaction data for both the treatment and control groups will be compared.
7 secondary outcomes
Hospital Readmission Rates
Time frame: Up to 5 years
Lab Orders and Results
Time frame: Up to 5 years
Prescribed and Dispensed Medications
Time frame: Up to 5 years
Pain Intensity
Time frame: Up to 5 years
Medical Costs
Time frame: Up to 5 years
Health Care Utilization
Time frame: Up to 5 years
Pain Specialist Referral Rates
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Noncancer Pain
Recruiting
Music as an Adjunct to Ketamine Therapy for Chronic Pain
Chronic Pain, Chronic Noncancer Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher A Harle, PhD principal investigator
University of Florida
Robert W Hurley, MD, PhD principal investigator
University of Florida
Nicole Marlow, PhD principal investigator
University of Florida
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providers of Novel Care in people with Chronic Noncancer Pain, run by University of Florida at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Satisfaction Survey (time frame: Up to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016; AzTrials last refreshed its copy on 31 Oct 2026.