Back PainMATCHNCT02286141
Matching Appropriate Treatments to Consumers' Healthcare Needs, MATCH
An observational study of Back Pain, run by Kaiser Permanente at 1 site in United States.
Trial summary
Back pain is one of the most common, controversial and costly problems in healthcare. Despite numerous studies, care for back pain has deteriorated over time and become much more expensive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- How many people
- 1,760 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group Health enrollees aged 18 and older who make a visit to one of the six primary care clinics participating in this study that results in a diagnosis of non-specific back pain.
Who may be able to join
- At least one primary care visit at one of the 6 Group Health clinics involved in this study resulting in a clinical Diagnosis of Back Pain.
Who cannot join
- Pregnancy, Blindness, Deafness, Unable to read or speak English, Paralysis, Psychoses, major, Dementia, Severe Vision problems Severe Hearing problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Evaluation of a Patient-Centered Risk Stratification Method for Improving Primary Care for Back Pain
Back pain is one of the most common, controversial and costly problems in healthcare. Despite numerous studies, care for back pain has deteriorated over time and become much more expensive. The risk stratification approach developed in England and found effective in National Health Service general practices in the UK provides a very promising strategy for improving care for back pain in the U.S.
The MATCH trial will use a cluster randomization design involving 6 primary care clinics at Group Health. Of these 6 clinics, 3 will be randomized to receive Group Health's standard training in the use of Group Health back pain guidelines and 3 clinics will receive this standard training plus supplemental training. Primary care clinicians and physical therapists in the intervention group will receive training in the use of the STarTBack risk stratification strategy for matching the most appropriate evidence-based treatments to the needs of patients in each risk level. We will evaluate the effect of this supplemental training on patient outcomes, clinician and physical therapist knowledge and comfort treating patients with back pain, and utilization of services for back pain.
Read the detailed description
Many Americans suffer from back pain for which no specific cause has been identified. Doctors in the United States do not have a standard toolkit of helpful treatments for addressing non-specific back pain. This contributes to frustration and unrelieved suffering for many patients and a sense of helplessness for many doctors. Recently, researchers in England developed a tool called "STarT Back" which helps doctors identify the types of treatments that are most likely to help patients with different pain experiences. This tool divides persons with back pain into three categories based on their answers to 9 simple questions about their pain and its effect on their lives. Doctors can then recommend treatments that are most likely to be helpful for patients in each category. This method has not yet been tested in the United States where healthcare is very different than in England. This project will test an enhanced version of the method at Group Health, a healthcare system in Washington State.
OBJECTIVES: A research team at Group Health will test how well an enhanced version of the STarT Back method works for patients with back pain. Since this method is new in the United States it is important to find out if it meets the needs of patients and doctors, and whether it can be easily used in the doctor's office.
The goals of this project are to:
- Adapt the STarT Back method for use at Group Health, using its computerized health record system.
- See how well the method works in three Group Health clinics, compared with three similar clinics where the method is not in place. We will learn from patients and doctors whether the method improved the treatment process and provided patients with greater relief from their back pain.
- Share the results of this study with other groups, including patients, doctors, healthcare leaders, and other scientists.
METHODS: It is important to understand whether using the method helps provide patients with more pain relief and improves their quality of life. We will invite patients visiting their primary care doctors for back pain to take part in the study. We will also ask doctors and care teams from these clinics to be part of this research. Patients who agree to be in the study will be asked questions about their back pain soon after their doctor visit and again 2 and 6 months later. These questions will be asked in a telephone or mailed survey. This information will allow us to see if using this approach in doctors' offices reduces pain and improves quality of life. We will also ask a small number of patients more in-depth questions to find out if there are ways we can improve this approach. Persons with back pain will be part of the research team. They will give their opinions about all details of the study, including the strategy for implementing the approach, the questions we ask patients and doctors, and how we report the results of the study.
- Conditions
- Back Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Patients receiving care at primary care clinics randomized to receive the supplemental training on stratified care for back pain through the use of the StartBack Tool will be considered to be a part of the intervention group. Randomization is done at the clinic level and not at the individual patient level. | |
| Control | Patients receiving care at primary care clinics randomized to receive the standard Group Health training on the updated Guidelines for Back Pain Care will be considered to be a part of the control group. Randomization is done at the clinic level and not at the individual patient level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain related dysfunction
Back-related dysfunction will be measured with the modified Roland Disability Questionnaire ("Roland scale"), which asks whether 23 specific activities were limited due to back pain during the past week (yes or no). This measure has been found to be reliable, valid and sensitive to clinical changes and is appropriate for telephone administration and patients with moderate disability.
Measured: 6 month
Back Pain Symptom Bothersomeness
Symptom bothersomeness will be measured by asking participants to rate how "bothersome" their back pain has been during the previous week on a 0 to 10 scale (0 = "not at all bothersome" and 10 = "extremely bothersome"). This question worked well in our previous trials and is highly correlated with a 0-10 measure of pain intensity (r=0.8 to 0.9). It is also highly correlated with measures of function and other outcome measures.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Daniel C Cherkin, PhD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286141
- Sponsor's protocol ID
- PCORI NA
- Acronym
- MATCH
- Status last verified
- Dec 2014
- First submitted
- 5 Nov 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hsu C, Evers S, Balderson BH, Sherman KJ, Foster NE, Estlin K, Levine M, Cherkin D. Adaptation and Implementation of the STarT Back Risk Stratification Strategy in a US Health Care Organization: A Process Evaluation. Pain Med. 2019 Jun 1;20(6):1105-1119. doi: 10.1093/pm/pny170.
PubMed 30272177Cherkin D, Balderson B, Wellman R, Hsu C, Sherman KJ, Evers SC, Hawkes R, Cook A, Levine MD, Piekara D, Rock P, Estlin KT, Brewer G, Jensen M, LaPorte AM, Yeoman J, Sowden G, Hill JC, Foster NE. Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care. J Gen Intern Med. 2018 Aug;33(8):1324-1336. doi: 10.1007/s11606-018-4468-9. Epub 2018 May 22.
PubMed 29790073Suri P, Delaney K, Rundell SD, Cherkin DC. Predictive Validity of the STarT Back Tool for Risk of Persistent Disabling Back Pain in a U.S. Primary Care Setting. Arch Phys Med Rehabil. 2018 Aug;99(8):1533-1539.e2. doi: 10.1016/j.apmr.2018.02.016. Epub 2018 Apr 3.
PubMed 29625095Cherkin D, Balderson B, Brewer G, Cook A, Estlin KT, Evers SC, Foster NE, Hill JC, Hawkes R, Hsu C, Jensen M, LaPorte AM, Levine MD, Piekara D, Rock P, Sherman K, Sowden G, Wellman R, Yeoman J. Evaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol. BMC Musculoskelet Disord. 2016 Aug 24;17(1):361. doi: 10.1186/s12891-016-1219-0.
PubMed 27553626
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Patient-Centered Risk Stratification Method for Improving Primary Care for Back Pain
- ClinicalTrials.gov ID
- NCT02286141
- Acronym / sponsor ID
- MATCH / PCORI NA
- Conditions
- Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,760 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 7 Nov 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.
Back pain is one of the most common, controversial and costly problems in healthcare. Despite numerous studies, care for back pain has deteriorated over time and become much more expensive. The risk stratification approach developed in England and found effective in National Health Service general practices in the UK provides a very promising strategy for improving care for back pain in the U.S.
The MATCH trial will use a cluster randomization design involving 6 primary care clinics at Group Health. Of these 6 clinics, 3 will be randomized to receive Group Health's standard training in the use of Group Health back pain guidelines and 3 clinics will receive this standard training plus supplemental training. Primary care clinicians and physical therapists in the intervention group will receive training in the use of the STarTBack risk stratification strategy for matching the most appropriate evidence-based treatments to the needs of patients in each risk level. We will evaluate the effect of this supplemental training on patient outcomes, clinician and physical therapist knowledge and comfort treating patients with back pain, and utilization of services for back pain.
Detailed description
Many Americans suffer from back pain for which no specific cause has been identified. Doctors in the United States do not have a standard toolkit of helpful treatments for addressing non-specific back pain. This contributes to frustration and unrelieved suffering for many patients and a sense of helplessness for many doctors. Recently, researchers in England developed a tool called "STarT Back" which helps doctors identify the types of treatments that are most likely to help patients with different pain experiences. This tool divides persons with back pain into three categories based on their answers to 9 simple questions about their pain and its effect on their lives. Doctors can then recommend treatments that are most likely to be helpful for patients in each category. This method has not yet been tested in the United States where healthcare is very different than in England. This project will test an enhanced version of the method at Group Health, a healthcare system in Washington State.
OBJECTIVES: A research team at Group Health will test how well an enhanced version of the STarT Back method works for patients with back pain. Since this method is new in the United States it is important to find out if it meets the needs of patients and doctors, and whether it can be easily used in the doctor's office.
The goals of this project are to:
- Adapt the STarT Back method for use at Group Health, using its computerized health record system.
- See how well the method works in three Group Health clinics, compared with three similar clinics where the method is not in place. We will learn from patients and doctors whether the method improved the treatment process and provided patients with greater relief from their back pain.
- Share the results of this study with other groups, including patients, doctors, healthcare leaders, and other scientists.
METHODS: It is important to understand whether using the method helps provide patients with more pain relief and improves their quality of life. We will invite patients visiting their primary care doctors for back pain to take part in the study. We will also ask doctors and care teams from these clinics to be part of this research. Patients who agree to be in the study will be asked questions about their back pain soon after their doctor visit and again 2 and 6 months later. These questions will be asked in a telephone or mailed survey. This information will allow us to see if using this approach in doctors' offices reduces pain and improves quality of life. We will also ask a small number of patients more in-depth questions to find out if there are ways we can improve this approach. Persons with back pain will be part of the research team. They will give their opinions about all details of the study, including the strategy for implementing the approach, the questions we ask patients and doctors, and how we report the results of the study.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | –Patients receiving care at primary care clinics randomized to receive the supplemental training on stratified care for back pain through the use of the StartBack Tool will be considered to be a part of the intervention group. Randomization is done at the clinic level and not at the individual patient level. |
| Control | – | –Patients receiving care at primary care clinics randomized to receive the standard Group Health training on the updated Guidelines for Back Pain Care will be considered to be a part of the control group. Randomization is done at the clinic level and not at the individual patient level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group Health enrollees aged 18 and older who make a visit to one of the six primary care clinics participating in this study that results in a diagnosis of non-specific back pain.
Key inclusion criteria (1 listed)
- At least one primary care visit at one of the 6 Group Health clinics involved in this study resulting in a clinical Diagnosis of Back Pain.
Key exclusion criteria (1 listed)
- Pregnancy, Blindness, Deafness, Unable to read or speak English, Paralysis, Psychoses, major, Dementia, Severe Vision problems Severe Hearing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Back pain related dysfunction
Time frame: 6 month
Back-related dysfunction will be measured with the modified Roland Disability Questionnaire ("Roland scale"), which asks whether 23 specific activities were limited due to back pain during the past week (yes or no). This measure has been found to be reliable, valid and sensitive to clinical changes and is appropriate for telephone administration and patients with moderate disability.
Back Pain Symptom Bothersomeness
Time frame: 6 month
Symptom bothersomeness will be measured by asking participants to rate how "bothersome" their back pain has been during the previous week on a 0 to 10 scale (0 = "not at all bothersome" and 10 = "extremely bothersome"). This question worked well in our previous trials and is highly correlated with a 0-10 measure of pain intensity (r=0.8 to 0.9). It is also highly correlated with measures of function and other outcome measures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Derived from this study: PubMed 30272177Hsu C, Evers S, Balderson BH, Sherman KJ, Foster NE, Estlin K, Levine M, Cherkin D. Adaptation and Implementation of the STarT Back Risk Stratification Strategy in a US Health Care Organization: A Process Evaluation. Pain Med. 2019 Jun 1;20(6):1105-1119. doi: 10.1093/pm/pny170.
- Derived from this study: PubMed 29790073Cherkin D, Balderson B, Wellman R, Hsu C, Sherman KJ, Evers SC, Hawkes R, Cook A, Levine MD, Piekara D, Rock P, Estlin KT, Brewer G, Jensen M, LaPorte AM, Yeoman J, Sowden G, Hill JC, Foster NE. Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care. J Gen Intern Med. 2018 Aug;33(8):1324-1336. doi: 10.1007/s11606-018-4468-9. Epub 2018 May 22.
- Derived from this study: PubMed 29625095Suri P, Delaney K, Rundell SD, Cherkin DC. Predictive Validity of the STarT Back Tool for Risk of Persistent Disabling Back Pain in a U.S. Primary Care Setting. Arch Phys Med Rehabil. 2018 Aug;99(8):1533-1539.e2. doi: 10.1016/j.apmr.2018.02.016. Epub 2018 Apr 3.
- Derived from this study: PubMed 27553626Cherkin D, Balderson B, Brewer G, Cook A, Estlin KT, Evers SC, Foster NE, Hill JC, Hawkes R, Hsu C, Jensen M, LaPorte AM, Levine MD, Piekara D, Rock P, Sherman K, Sowden G, Wellman R, Yeoman J. Evaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol. BMC Musculoskelet Disord. 2016 Aug 24;17(1):361. doi: 10.1186/s12891-016-1219-0.
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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.
Daniel C Cherkin, PhD principal investigator
Group Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by Kaiser Permanente at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Back pain related dysfunction (time frame: 6 month). 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?
On the ClinicalTrials.gov record for NCT02286141, which also lists 4 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 23 Dec 2014.