PainESPNCT01816763
Effective Screening for Pain Study
A study testing NRS pain one week, PEG and DVPRS in people with Pain and Pain Management, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain Management
- What is being tested?
- NRS pain one week, PEG and DVPRS
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2015to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Veterans are eligible to participate in the clinical trial when presenting for routine care in the primary care clinic at all sites (VA at Palo Alto, Minneapolis, and Portland).
- All are eligible who do not opt out of participation.
- All participants in the baseline tablet intervention will also be eligible for a one week follow up telephone interview - unless they are unable to complete a phone interview (see exclusions).
- For the qualitative Veteran component, all Veterans who can hear and respond in an interview are eligible.
- Providers/staff must be clinic and facility staff including administrative clerks, regular part time or full time employees in primary care who routinely participate in the care of Veterans who have painful conditions.
Who cannot join
- Veterans who meet either of the following exclusion criteria that may interfere with outcome assessment will be ineligible for the follow up telephone interview:
- a) no working telephone (home, office, or mobile)
- b) hearing impaired and unable to complete a phone survey
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS).
The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products.
Read more
Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference. The PEG is very similar to the gold standard Brief Pain Inventory (BPI) from which it is derived, in its sensitivity, specificity, and sensitivity to change in detecting clinically important, functionally impairing pain.
The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered NRS.
Read the detailed description
Background:
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS).
The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products.
Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference.
The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered pain now.
Objectives:
- Qualitatively evaluate Veteran and multidisciplinary provider perspectives on pain screening and the use of the NRS vs. the PEG items, clinician-assessed vs. patient-reported pain 2a) Quantitatively assess, in a 3-arm randomized controlled primary care clinical team-based trial using tablets, the feasibility and completion rates, validity, and variability of pain information obtained comparing: Tablet-based vs. nurse-documented pain (e.g., 5th vital sign by tablet vs. clinician assessed) and the rate and severity of pain detected in tablet-based 'NRS one week' (Arm 1), tablet-based PEG (Arm 2), and DVPRS (Arm 3). Also pain, self-reported disability.
2b) Informed by Aims 1 and 2a, qualitatively evaluate provider perspectives on different pain reports to facilitate better pain management.
Methods:
The investigators are conducting a two phase mixed method study that will build on prior work to develop and test enhanced pain screening approaches for primary care and Patient Aligned Care Teams (PACTs). In the first (development) phase of the study, the investigators will conduct semi-structured qualitative interviews and focus groups with primary care clinicians, other primary care team members including non-provider staff, and primary care Veteran patients, to understand what patient-reported pain assessment data are most useful for clinical decision-making and how this pain information can best be integrated into primary care team processes, including the role of informatics to optimize primary care pain management and link pain screening to management. This will inform the development of the enhanced pain screening approaches used in the Aim 2 randomized controlled trial (RCT). The investigators will also submit the enhanced tablet-based pain screening approaches to usability testing by the University of California Office of Information Technology.
The second (testing) phase of the study will include a multisite RCT to test the final enhanced pain screening approaches (Arm 1 PEG; Arm 2 NRS 'pain now', Arm 3 DVPRS) compared with the NRS one week (all Arms), on patient and primary care clinician outcomes. The investigators will assess whether the approaches improve detection of pain-related impairment, and also the feasibility, acceptability, and provider and patient experience with enhanced screening.
Status:
The investigators have completed data collection, coding, and analyses for all Aims. They have presented some findings as conference posters and presentations and published several manuscripts.
Findings from Aim 1 were used to guide the development of a tablet-based pain screening survey that the investigators tested in Aim 2a as a randomized control trial. The investigators have have completed data collection, and are currently analyzing results.
- Conditions
- Pain, Pain Management
- Being tested
- NRS pain one week, PEG, DVPRS
- Keywords
- Health Care Quality, Access, and Evaluation, Primary Health Care, Medical Informatics
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRS pain one weekBehavioural
Eligible patients will be randomly assigned to complete a patient-reported 'NRS one week' on a tablet prior to making contact with a nursing staff vital signs screener.
PEGBehavioural
Eligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener.
DVPRSBehavioural
Eligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener.
| Study group | Role | What they receive |
|---|---|---|
| tablet based NRS pain one week, followed by nurse pain screen | Experimental | tablet-based patient self-report of the 'NRS pain one week' Receives: Behavioral: NRS pain one week |
| tablet based PEG, followed by nurse pain screen | Experimental | tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) Receives: Behavioral: PEG |
| DVPRS, followed by nurse pain screen | Experimental | Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now Receives: Behavioral: DVPRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity)
pain (Numeric Rating Scale - NRS and PEG (full scale name) and Defense Veterans Pain Rating Scale - DVPRS measures) using overall pain derived from each of the three measures compared cross sectionally with the three pain intensity items and scale of the Chronic Pain Grade (CPG) questionnaire. The latter addresses pain 'now', average pain, and worst pain. All measures (NRS, PEG, DVPRS, and CPG) are scored from 0-10 where 0 equals no pain and 10 equals worst possible pain.). the NRS is a one item pain intensity measure, the PEG is a 3 item measure combining pain intensity, pain-related emotional and functional interference, and the DVPRS integrates pain intensity, pain interference, faces pain, and colormetric indicators on a 0-10 overall pain scale. The study used no subscales for the NRS, PEG, or DVPRS, and all values reported are total measure scores, computed as the average of items. We compare them to the pain intensity score of the CPG. Higher scores signify worse pain.
Measured: Baseline (e.g., time of clinic visit) measures were cross sectionally assessed
Secondary outcomes (2)
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen
Number of persons who failed to complete (NRS and PEG and DVPRS measures). the measures vary in complexity as the NRS is one item, the PEG 3 items, and the DVPRS includes 10 items integrating color, faces pain, function, and intensity descriptions of pain. Measures are fully described in Outcome 1 description.
Measured: Baseline cross sectional comparison at the time of clinic visit
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Number of Participants Who Rated Overall Functional Status Worse Relative to Peers Using the Gill Single Item Questionnaire
descriptive analysis comparing overall pain rated by the three measures at Baseline (NRS, PEG, DVPRS), two of which include function (PEG and DVPRS), using the outcome of pre-specified single item of self-reported function compared to one's peers as validated by Gill et. al.. All pain outcome measures (NRS, PEG, DVPRS) are described fully in Outcome 1. Gill single item is not otherwise formally named. It is a 3 item scale querying "self rated activity level relative to peers" where the categories include "less active, about as active, and more active" and is scored as a categorical 0-2 rating where 2 is optimal and 0 is worst relative function.
Measured: Baseline cross-sectional comparison at time of clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJun 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karl A. Lorenz, MD MSHS, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816763
- Sponsor's protocol ID
- CRE 12-030
- Acronym
- ESP
- Status last verified
- May 2019
- First submitted
- 11 Mar 2013
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Giannitrapani KF, Ahluwalia SC, McCaa M, Pisciotta M, Dobscha S, Lorenz KA. Barriers to Using Nonpharmacologic Approaches and Reducing Opioid Use in Primary Care. Pain Med. 2018 Jul 1;19(7):1357-1364. doi: 10.1093/pm/pnx220.
PubMed 29059412Haverfield MC, Giannitrapani K, Timko C, Lorenz K. Patient-Centered Pain Management Communication from the Patient Perspective. J Gen Intern Med. 2018 Aug;33(8):1374-1380. doi: 10.1007/s11606-018-4490-y. Epub 2018 May 29.
PubMed 29845465Giannitrapani K, McCaa M, Haverfield M, Kerns RD, Timko C, Dobscha S, Lorenz K. Veteran Experiences Seeking Non-pharmacologic Approaches for Pain. Mil Med. 2018 Nov 1;183(11-12):e628-e634. doi: 10.1093/milmed/usy018.
PubMed 29590422Ahluwalia SC, Giannitrapani KF, Dobscha SK, Cromer R, Lorenz KA. "It Encourages Them to Complain": A Qualitative Study of the Unintended Consequences of Assessing Patient-Reported Pain. J Pain. 2018 May;19(5):562-568. doi: 10.1016/j.jpain.2017.12.270. Epub 2018 Feb 5.
PubMed 29421247Giannitrapani KF, Day RT, Azarfar A, Ahluwalia SC, Dobscha S, Lorenz KA. What Do Providers Want from a Pain Screening Measure Used in Daily Practice? Pain Med. 2019 Jan 1;20(1):68-76. doi: 10.1093/pm/pny135.
PubMed 30085285Giannitrapani KF, Glassman PA, Vang D, McKelvey JC, Thomas Day R, Dobscha SK, Lorenz KA. Expanding the role of clinical pharmacists on interdisciplinary primary care teams for chronic pain and opioid management. BMC Fam Pract. 2018 Jul 3;19(1):107. doi: 10.1186/s12875-018-0783-9.
PubMed 29970008Giannitrapani KF, Ahluwalia SC, Day RT, Pisciotta M, Dobscha S, Lorenz K. Challenges to teaming for pain in primary care. Healthc (Amst). 2018 Mar;6(1):23-27. doi: 10.1016/j.hjdsi.2017.06.006. Epub 2017 Jul 13. No abstract available.
PubMed 28711504
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Screening for Pain Study
- ClinicalTrials.gov ID
- NCT01816763
- Acronym / sponsor ID
- ESP / CRE 12-030
- Conditions
- Pain, Pain Management
- Keywords
- Health Care Quality, Access, and Evaluation, Primary Health Care, Medical Informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jun 2015
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS).
The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products.
Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference. The PEG is very similar to the gold standard Brief Pain Inventory (BPI) from which it is derived, in its sensitivity, specificity, and sensitivity to change in detecting clinically important, functionally impairing pain.
The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered NRS.
Detailed description
Background:
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS).
The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products.
Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference.
The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered pain now.
Objectives:
- Qualitatively evaluate Veteran and multidisciplinary provider perspectives on pain screening and the use of the NRS vs. the PEG items, clinician-assessed vs. patient-reported pain 2a) Quantitatively assess, in a 3-arm randomized controlled primary care clinical team-based trial using tablets, the feasibility and completion rates, validity, and variability of pain information obtained comparing: Tablet-based vs. nurse-documented pain (e.g., 5th vital sign by tablet vs. clinician assessed) and the rate and severity of pain detected in tablet-based 'NRS one week' (Arm 1), tablet-based PEG (Arm 2), and DVPRS (Arm 3). Also pain, self-reported disability.
2b) Informed by Aims 1 and 2a, qualitatively evaluate provider perspectives on different pain reports to facilitate better pain management.
Methods:
The investigators are conducting a two phase mixed method study that will build on prior work to develop and test enhanced pain screening approaches for primary care and Patient Aligned Care Teams (PACTs). In the first (development) phase of the study, the investigators will conduct semi-structured qualitative interviews and focus groups with primary care clinicians, other primary care team members including non-provider staff, and primary care Veteran patients, to understand what patient-reported pain assessment data are most useful for clinical decision-making and how this pain information can best be integrated into primary care team processes, including the role of informatics to optimize primary care pain management and link pain screening to management. This will inform the development of the enhanced pain screening approaches used in the Aim 2 randomized controlled trial (RCT). The investigators will also submit the enhanced tablet-based pain screening approaches to usability testing by the University of California Office of Information Technology.
The second (testing) phase of the study will include a multisite RCT to test the final enhanced pain screening approaches (Arm 1 PEG; Arm 2 NRS 'pain now', Arm 3 DVPRS) compared with the NRS one week (all Arms), on patient and primary care clinician outcomes. The investigators will assess whether the approaches improve detection of pain-related impairment, and also the feasibility, acceptability, and provider and patient experience with enhanced screening.
Status:
The investigators have completed data collection, coding, and analyses for all Aims. They have presented some findings as conference posters and presentations and published several manuscripts.
Findings from Aim 1 were used to guide the development of a tablet-based pain screening survey that the investigators tested in Aim 2a as a randomized control trial. The investigators have have completed data collection, and are currently analyzing results.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tablet based NRS pain one week, followed by nurse pain screen | Experimental | Behavioral: NRS pain one weektablet-based patient self-report of the 'NRS pain one week' |
| tablet based PEG, followed by nurse pain screen | Experimental | Behavioral: PEGtablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) |
| DVPRS, followed by nurse pain screen | Experimental | Behavioral: DVPRSDefense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All Veterans are eligible to participate in the clinical trial when presenting for routine care in the primary care clinic at all sites (VA at Palo Alto, Minneapolis, and Portland).
- All are eligible who do not opt out of participation.
- All participants in the baseline tablet intervention will also be eligible for a one week follow up telephone interview - unless they are unable to complete a phone interview (see exclusions).
- For the qualitative Veteran component, all Veterans who can hear and respond in an interview are eligible.
- Providers/staff must be clinic and facility staff including administrative clerks, regular part time or full time employees in primary care who routinely participate in the care of Veterans who have painful conditions.
Key exclusion criteria (3 listed)
- Veterans who meet either of the following exclusion criteria that may interfere with outcome assessment will be ineligible for the follow up telephone interview:
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 |
|---|---|---|
| NRS pain one weekEligible patients will be randomly assigned to complete a patient-reported 'NRS one week' on a tablet prior to making contact with a nursing staff vital signs screener. | Behavioural | tablet based NRS pain one week, followed by nurse pain screen |
| PEGEligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener. | Behavioural | tablet based PEG, followed by nurse pain screen |
| DVPRSEligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener. | Behavioural | DVPRS, followed by nurse pain screen |
Primary outcome
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity)
Time frame: Baseline (e.g., time of clinic visit) measures were cross sectionally assessed
pain (Numeric Rating Scale - NRS and PEG (full scale name) and Defense Veterans Pain Rating Scale - DVPRS measures) using overall pain derived from each of the three measures compared cross sectionally with the three pain intensity items and scale of the Chronic Pain Grade (CPG) questionnaire. The latter addresses pain 'now', average pain, and worst pain. All measures (NRS, PEG, DVPRS, and CPG) are scored from 0-10 where 0 equals no pain and 10 equals worst possible pain.). the NRS is a one item pain intensity measure, the PEG is a 3 item measure combining pain intensity, pain-related emotional and functional interference, and the DVPRS integrates pain intensity, pain interference, faces pain, and colormetric indicators on a 0-10 overall pain scale. The study used no subscales for the NRS, PEG, or DVPRS, and all values reported are total measure scores, computed as the average of items. We compare them to the pain intensity score of the CPG. Higher scores signify worse pain.
2 secondary outcomes
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen
Time frame: Baseline cross sectional comparison at the time of clinic visit
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Number of Participants Who Rated Overall Functional Status Worse Relative to Peers Using the Gill Single Item Questionnaire
Time frame: Baseline cross-sectional comparison at time of clinic visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29059412Giannitrapani KF, Ahluwalia SC, McCaa M, Pisciotta M, Dobscha S, Lorenz KA. Barriers to Using Nonpharmacologic Approaches and Reducing Opioid Use in Primary Care. Pain Med. 2018 Jul 1;19(7):1357-1364. doi: 10.1093/pm/pnx220.
- Background: PubMed 29845465Haverfield MC, Giannitrapani K, Timko C, Lorenz K. Patient-Centered Pain Management Communication from the Patient Perspective. J Gen Intern Med. 2018 Aug;33(8):1374-1380. doi: 10.1007/s11606-018-4490-y. Epub 2018 May 29.
- Background: PubMed 29590422Giannitrapani K, McCaa M, Haverfield M, Kerns RD, Timko C, Dobscha S, Lorenz K. Veteran Experiences Seeking Non-pharmacologic Approaches for Pain. Mil Med. 2018 Nov 1;183(11-12):e628-e634. doi: 10.1093/milmed/usy018.
- Background: PubMed 29421247Ahluwalia SC, Giannitrapani KF, Dobscha SK, Cromer R, Lorenz KA. "It Encourages Them to Complain": A Qualitative Study of the Unintended Consequences of Assessing Patient-Reported Pain. J Pain. 2018 May;19(5):562-568. doi: 10.1016/j.jpain.2017.12.270. Epub 2018 Feb 5.
- Background: PubMed 30085285Giannitrapani KF, Day RT, Azarfar A, Ahluwalia SC, Dobscha S, Lorenz KA. What Do Providers Want from a Pain Screening Measure Used in Daily Practice? Pain Med. 2019 Jan 1;20(1):68-76. doi: 10.1093/pm/pny135.
- Background: PubMed 29970008Giannitrapani KF, Glassman PA, Vang D, McKelvey JC, Thomas Day R, Dobscha SK, Lorenz KA. Expanding the role of clinical pharmacists on interdisciplinary primary care teams for chronic pain and opioid management. BMC Fam Pract. 2018 Jul 3;19(1):107. doi: 10.1186/s12875-018-0783-9.
- Results publication: PubMed 28711504Giannitrapani KF, Ahluwalia SC, Day RT, Pisciotta M, Dobscha S, Lorenz K. Challenges to teaming for pain in primary care. Healthc (Amst). 2018 Mar;6(1):23-27. doi: 10.1016/j.hjdsi.2017.06.006. Epub 2017 Jul 13. No abstract available.
- Individual participant dataSharing planned: No
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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.
Karl A. Lorenz, MD MSHS principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NRS pain one week, PEG and DVPRS in people with Pain and Pain Management, run by VA Office of Research and Development at 3 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 5 inclusion and 3 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity) (time frame: Baseline (e.g., time of clinic visit) measures were cross sectionally assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816763, which also lists 7 linked publications.
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 19 Jul 2019.