NCT02286141

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,760

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

November 5, 2014

Last Update Submit

December 22, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 month

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy, Blindness, Deafness, Unable to read or speak English, Paralysis, Psychoses, major, Dementia, Severe Vision problems Severe Hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

  • 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.

  • Cherkin 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.

  • Suri 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.

  • Cherkin 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.

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel C Cherkin, PhD

    Group Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations