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Background: Management of osteoarthritis requires both med- tient Health Questionnaire-8). Linear mixed models that were ad-
ical and behavioral strategies, but some recommended thera- justed for clustering of providers assessed between-group differ-
pies are underused. ences in improvement in outcomes.
Objective: To examine the effectiveness of a combined patient Results: At 12 months, WOMAC scores were 4.1 points lower
and provider intervention for improving osteoarthritis outcomes. (indicating improvement) in the osteoarthritis intervention group
versus usual care (95% CI, ⫺7.2 to ⫺1.1 points; P = 0.009).
Design: Cluster randomized clinical trial with assignment to os- WOMAC function subscale scores were 3.3 points lower in the
teoarthritis intervention and usual care groups. (ClinicalTrials intervention group (CI, ⫺5.7 to ⫺1.0 points; P = 0.005). WOMAC
.gov: NCT01130740) pain subscale scores (P = 0.126), physical performance, and de-
Setting: Department of Veterans Affairs Medical Center in Dur- pressive symptoms did not differ between groups. Although
ham, North Carolina. more patients in the osteoarthritis intervention group received
provider referral for recommended osteoarthritis treatments, the
Participants: 30 providers (clusters) and 300 outpatients with numbers who received them did not differ.
symptomatic hip or knee osteoarthritis.
Limitation: The study was conducted in a single Veterans Affairs
Intervention: The telephone-based patient intervention fo- medical center.
cused on weight management, physical activity, and cognitive
behavioral pain management. The provider intervention in- Conclusion: The combined patient and provider intervention
volved delivery of patient-specific osteoarthritis treatment rec- resulted in modest improvement in self-reported physical func-
ommendations to primary care providers through the electronic tion in patients with hip and knee osteoarthritis.
medical record. Primary Funding Source: Department of Veterans Affairs,
Measurements: The primary outcome was total score on the Health Services Research and Development Service.
Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC) at 12 months. Secondary outcomes were WOMAC Ann Intern Med. 2016;164:73-83. doi:10.7326/M15-0378 www.annals.org
function and pain subscale scores, physical performance (Short For author affiliations, see end of text.
Physical Performance Battery), and depressive symptoms (Pa- This article was published at www.annals.org on 22 December 2015.
missing observations, we multiply imputed missing There were 151 and 149 patient participants in the os-
WOMAC follow-up scores using a Markov-chain Monte teoarthritis intervention and usual care groups, respec-
Carlo algorithm incorporating additional variables be- tively. One patient was assigned to a usual care pro-
yond those in the linear mixed-effects models to vider at the beginning of the recruitment process but
strengthen the missing-at-random assumption (Supple- switched to an osteoarthritis intervention provider be-
ment, available at www.annals.org). fore being notified of his study group assignment. We
For primary and secondary outcomes and continu- decided to include the participant in the assigned
ous process measures, linear mixed models were fit us- group of his provider at the time of notification of ran-
ing the PROC MIXED procedure in SAS, version 9.4 dom assignment (osteoarthritis intervention).
(SAS Institute) (44). A random effect to account for clus- Among enrolled participants, 88% completed
tering of PCPs and an unstructured covariance struc- 6-month measures and 91% completed 12-month mea-
ture for the repeated measures over time were used. sures (Figure). Seventeen participants were withdrawn
For CHAMPS outcomes, the change from baseline to by the study team (10 [3 in the osteoarthritis interven-
12 months was used due to normality assumptions. tion group and 7 in the usual care group] underwent
Predictors in all models included dummy-coded hip or knee replacement or another significant hip or
follow-up time effects and an indicator variable for the knee surgery; 3 [1 in the osteoarthritis intervention
interaction between the intervention and follow-up group and 2 in the usual care group] developed a se-
time effects (45). This model assumed that study rious health condition that would have made general-
groups had equal baseline means, which is appropriate ized exercise or diet advice risky; 2 [1 in each group]
for a randomized, controlled trial and is equivalent in became ineligible after giving consent; 1 in the osteo-
efficiency to an analysis-of-covariance model (46). The arthritis intervention group moved out of the area, mak-
final models also included patient participant race and ing it impossible for treatment recommendations to be
the provider stratification based on the proportion of issued; and 1 switched from an osteoarthritis interven-
female patients. Our primary inference was on the tion provider to a usual care provider before treatment
interaction between the intervention group and recommendations were issued). In addition, 5 patients
follow-up time because this was the estimated differ- withdrew from the study and 5 were lost to follow-up.
ence between groups at the end of the study. For the
change in CHAMPS scores between baseline and 12 Intervention Delivery
months, fixed-effect terms in the model included base- The average number of patient participants en-
line CHAMPS score and an indicator variable for study rolled was 10.0 (SD, 2.1; range, 3 to 12) per provider.
group. For the BMI analysis, in-person weight at the Osteoarthritis intervention participants completed an
12-month follow-up visit was the outcome; sensitivity average of 11.5 (SD, 4.9) of 18 planned telephone calls,
analyses included self-reported weight from partici- and the average length of the calls was 16.6 minutes
pants without an in-person 12-month visit. (SD, 12.4). The study team was able to deliver treat-
In a post hoc analysis that examined clinically ment recommendations to the PCP within the interven-
meaningful change in WOMAC scores (based on prior tion period for all but 8 patient participants. Of these, 2
studies of behavioral and rehabilitative interventions) were withdrawn by the study team, 1 withdrew, 1 was
(37, 39, 47), we categorized patients as either improved reassigned to a nonstudy PCP who had not yet seen the
or not improved at 12 months using a 12% improve- patient, 2 transferred to another VA medical center,
ment (5.8-point reduction) and an 18% improvement and 2 were inadvertently missed by the study team. For
(8.7-point reduction) in the total score from baseline, 26 participants, nonacute visits were scheduled with
which corresponded with the upper and lower range of PCPs not enrolled in the study; in all but 1 case, the
previously reported estimates of clinically meaningful covering PCP agreed to receive the recommendations.
change. We used generalized estimating equation The mean number of recommendations issued was 4.6
models (48) with a logit link function and an unstruc- (SD, 1.8) per patient participant.
tured correlation structure and used empirical SEs for Adverse Events
inference. Four adverse events occurred, but none was asso-
Role of the Funding Source ciated with the osteoarthritis intervention.
The funding source approved the project and mon-
Primary Outcome
itored progress but had no direct role in the design or
At 12 months, the estimated mean change in total
conduct of the study, data analyses, or the decision to
WOMAC score was ⫺4.0 points (95% CI, ⫺6.2 to ⫺1.8
submit the manuscript for publication.
points) in the osteoarthritis intervention group and 0.1
point (CI, ⫺2.1 to 2.3 points) in the usual care group,
RESULTS with an estimated mean difference of ⫺4.1 points (CI,
Participant Enrollment and Retention ⫺7.2 to ⫺1.1 points; P = 0.009) between groups (Table
Forty-three PCPs were approached, and 30 were 2). Both groups showed improvement at 6 months
enrolled (Figure and Table 1). We identified 5094 po- compared with baseline, with the mean score for the
tential patient participants from the EMR. Of 1053 pa- usual care group returning to baseline levels by 12
tients screened by telephone, 356 were eligible and months. WOMAC scores also increased between 6 and
300 were enrolled and randomly assigned (Table 1). 12 months for participants in the osteoarthritis interven-
76 Annals of Internal Medicine • Vol. 164 No. 2 • 19 January 2016 www.annals.org
PCPs approached
(n = 43)
Declined: 10
Consented but left the Durham
VA Medical Center before
randomization: 3
PCPs who consented and
were randomly assigned
(n = 30)
Patients Patients
identified from identified from
Ineligible: 978
medical records medical records Ineligible: 835
Declined participation: 85
(n = 2779) (n = 2315) Declined participation: 81
Not approached
Not approached
(enrollment goal
(enrollment goal
reached for PCP): 1130
reached for PCP): 932
Screened Screened
(n = 586) (n = 467)
tion group but remained below baseline scores. We care group (odds ratio, 1.3 [CI, 0.9 to 1.8]; P = 0.118);
observed a clustering effect for WOMAC scores within 29.7% improved by at least 18% in the osteoarthritis
provider, with an estimated intraclass correlation coef- intervention group compared with 22.2% in the usual
ficient of 0.02. We found similar results when we used care group (odds ratio, 1.3 [CI, 0.8 to 2.1]; P = 0.22).
the multiply imputed data sets (mean difference, ⫺4.2
points [CI, ⫺7.3 to ⫺1.2 points]; P = 0.007). In post hoc Secondary Outcomes
analyses examining improvements in WOMAC scores We found no difference between groups in the
from baseline to 12 months, an estimated 42.0% of par- WOMAC pain subscale score (P = 0.59 at 6 months and
ticipants improved by at least 12% in the osteoarthritis 0.126 at 12 months) (Table 2). However, at 12 months,
intervention group compared with 32.2% in the usual the estimated mean WOMAC physical function score in
www.annals.org Annals of Internal Medicine • Vol. 164 No. 2 • 19 January 2016 77
the osteoarthritis intervention group was 3.3 points patient participants with self-reported weight at 12
lower (CI, ⫺5.7 to ⫺1.0 points; P = 0.005) than in the months.
usual care group. For objective physical function and
depressive symptoms, we found no differences be- Osteoarthritis Treatment Recommendations
tween groups (Table 2). Because some patient partici- and Use
pants completed 12-month follow-up assessments by Table 3 shows proportions of all patient partici-
telephone, SPPB scores were missing more often at this pants (by study group) who received specific
time point than the self-reported measures (see Table 2 osteoarthritis-related referrals and treatments or visits
for details). during the study. Referrals to several rehabilitative and
behavioral therapies were higher in the osteoarthritis
Process Measures intervention group than in the usual care group, includ-
Patient participants in the osteoarthritis interven- ing physical therapy (12% vs. 7%), knee braces (19% vs.
tion group had greater improvement in both the fre- 11%), and MOVE! (20% vs. 3%). However, the numbers
quency (3.3 more times per week [P = 0.009]) and du- of patients who actually received these therapies at the
ration (3.6 more hours per week [P = 0.003]) of all Durham VA Medical Center during the study were low
physical activity at 12 months than those in the usual in both groups. Referrals for and receipt of joint injec-
care group (Table 2). Results were similar for change in tions were similar between groups, as were orthopedic
physical activity of moderate or greater intensity, with visits. Referrals were not needed for topical pain med-
increases of 1.6 times and 1.6 hours per week in the ications, NSAIDs, or alternative pain medications. Simi-
osteoarthritis intervention group compared with the lar proportions of patient participants in the osteoar-
usual care group (P = 0.042 and 0.017, respectively). thritis intervention and usual care groups reported new
We found no difference between groups for BMI. Re- use of topical creams (NSAIDs or capsaicin) at 12
sults were similar in sensitivity analyses that included months (9% and 7%, respectively). The proportions of
78 Annals of Internal Medicine • Vol. 164 No. 2 • 19 January 2016 www.annals.org
Table 2. Estimated Mean Differences Between Usual Care and Intervention Groups in Patient Outcomes*
BMI, kg/m2
Baseline 33.8 33.8 NA NA
12 mo 33.6 33.5 −0.1 (−0.5 to 0.2) 0.47
BMI = body mass index; CHAMPS = Community Healthy Activities Model Program for Seniors; NA = not applicable; PHQ-8 = Patient Health
Questionnaire-8; SPPB = Short Physical Performance Battery; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index.
* Linear mixed model results. 37 (21 in the osteoarthritis intervention group and 16 in the usual care group) and 27 (15 in the osteoarthritis
intervention group and 12 in the usual care group) participants had no follow-up data at 6 and 12 mo, respectively. In addition, WOMAC scores
were missing in 6 participants (1 at baseline, 2 in the osteoarthritis intervention group and 1 in the usual care group at 6 mo, and 1 in the
osteoarthritis intervention group and 1 in the usual care group at 12 mo), SPPB scores were missing in 55 participants (16 at baseline and 21 in
the osteoarthritis intervention group and 18 in the usual care group at 12 mo), PHQ-8 scores were missing in 19 participants (4 at baseline and 5
in the osteoarthritis intervention group and 10 in the usual care group at 12 mo), data on frequency and duration of exercise were missing in 11
participants (1 at baseline and 4 in the osteoarthritis intervention group and 6 in the usual care group at 12 mo), and measured BMI was missing in
4 participants (3 in the osteoarthritis intervention group and 1 in the usual care group). Additional data were missing across all time points because
of scoring algorithms and persons who declined to participate.
† May not match estimated difference in means because of rounding.
cally significant or clinically relevant differences be- which are below these thresholds. We found that 42%
tween groups for other secondary outcomes and pro- and 30% of patient participants in the osteoarthritis
cess measures, including WOMAC pain subscale score, intervention group achieved at least 12% and 18%
depressive symptoms, and BMI (51, 52). improvement in WOMAC total scores, respectively.
Effects of this osteoarthritis intervention on Future analyses will examine whether specific partici-
WOMAC total and function subscale scores were mod- pant characteristics were associated with differential
est. In the context of behavioral and rehabilitative inter- improvement.
ventions for osteoarthritis, thresholds for clinically In both study groups, WOMAC scores improved by
meaningful improvements in WOMAC score have typi- the interim 6-month follow-up assessment, with greater
cally ranged from 12% to 18% (37–39). In this study, we improvement in the osteoarthritis intervention group.
observed an 8.5% improvement in WOMAC total Scores then increased by 12 months (indicating re-
scores and a 9.8% improvement in WOMAC function lapse) in both groups and remained lower than at base-
scores in the osteoarthritis intervention group, both of line in the osteoarthritis intervention group only. In this
Table 4. Treatment Recommendations, Referrals, and Treatment Receipt in the Osteoarthritis Intervention Group*
Treatment/Visit PCP Received Treatment Patient Received Treatment Patient Received Treatment
Recommendation From Study Recommendation and Referral Recommendation, Referral,
Team, n (%) From PCP, n (%)† and Treatment, n (%)‡
Physical therapy§ 74 (49.0) 15 (20.3) 1 (6.7)
Knee osteoarthritis – – 0 (0)
Hip osteoarthritis – – 1 (6.7)
Knee brace 62 (41.1) 22 (35.5) 2 (9.1)
MOVE!兩兩 131 (86.8) 30 (22.9) 8 (26.7)
Weight and physical activity 110 (72.9) 25 (22.7) 7 (28.0)
Weight only 14 (9.3) 2 (14.3) 0 (0)
Physical activity only 7 (4.6) 3 (42.9) 1 (33.3)
Orthopedic visit§ 18 (11.9) 2 (11.1) 0 (0)
Knee osteoarthritis – – 0 (0)
Hip osteoarthritis – – 0 (0)
Joint injection 33 (21.9) NA 9 (27.3)
Topical NSAID or capsaicin 75 (49.7) NA 11 (14.7)
Add gastroprotective agent or remove NSAID 16 (10.6) NA NA¶
Discuss new/alternative pain medication 125 (82.8) NA 46 (36.8)
NA = not available; NSAID = nonsteroidal anti-inflammatory drug; PCP = primary care provider.
* Data were missing on treatment recommendations in 8 participants (recommendations unable to be issued), receipt of topical creams in 16
participants in the usual care group and 16 in the osteoarthritis intervention group, and receipt of oral pain medication in 12 participants in the usual
care group and 15 in the osteoarthritis intervention group.
† Number of participants who received treatment recommendations was used as denominator.
‡ For physical therapy, knee braces, MOVE!, and orthopedic visits, proportions were calculated using the number of participants who received
treatment recommendations and referrals during the study as the denominator. For joint injections (which can be done by a PCP without a specialty
consultation), topical creams, and oral pain medications, proportions were calculated using the number of participants who received treatment
recommendations as the denominator.
§ Treatment recommendations and referrals did not differentiate between hip and knee osteoarthritis.
兩兩 Participants could receive MOVE! recommendations for physical activity, weight management, or both. These recommendations are listed
separately, but provider referrals and MOVE! visits did not differentiate.
¶ Could not be captured because use of NSAIDs could not be reliably assessed in medical records.
Center, 508 Fulton Street, Durham, NC 27705; e-mail, Kelli ison of African Americans and whites in a prospective study of
.allen@va.gov. osteoarthritis. Arthritis Care Res (Hoboken). 2013;65:5-14. [PMID:
22833527]
17. Ganz DA, Chang JT, Roth CP, Guan M, Kamberg CJ, Niu F, et al.
Current author addresses and author contributions are avail- Quality of osteoarthritis care for community-dwelling older adults.
able at www.annals.org. Arthritis Rheum. 2006;55:241-7. [PMID: 16583414]
18. Asch SM, McGlynn EA, Hogan MM, Hayward RA, Shekelle P,
Rubenstein L, et al. Comparison of quality of care for patients in the
Veterans Health Administration and patients in a national sample.
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Refer for Evaluation for Knee Brace Patient Reports Taking an NSAID (Prescription
Criteria for each knee with osteoarthritis: or Over-the-Counter) but Has Risk Factors for
Y Patient is not currently using a knee brace, AND Gastrointestinal (GI) Bleeding; Consider
Y Patient may be interested in trying a knee Addition of Gastroprotective Agent or Switch to
brace (or different kind of knee brace) if their provider Other Pain Medication
recommends. Criteria:
Criteria for specific brace consults (VA-based study Y Patient is currently using an NSAID without gas-
only) troprotective agent, AND
Y Knee sleeve: knee pain rating of 1 to 3 (on a Y Patient has ≥1 risk factor for GI bleeding: age
10-cm visual analogue scale) AND varus/valgus align- ≥75 years, history of peptic ulcer disease or GI bleed-
ment <10° AND does not indicate knee “buckling”. ing, current glucocorticoid use.
www.annals.org Annals of Internal Medicine • Vol. 164 No. 2 • 19 January 2016