RESULTS

David Edelman; Jennifer R McDuffie; Eugene Oddone; Jennifer M Gierisch; Avishek Nagi; John W Williams, Jr

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Edelman D, McDuffie JR, Oddone E, et al. Shared Medical Appointments for Chronic Medical Conditions: A Systematic Review [Internet]. Washington (DC): Department of Veterans Affairs (US); 2012 Jul.

Cover of Shared Medical Appointments for Chronic Medical Conditions: A Systematic Review

Shared Medical Appointments for Chronic Medical Conditions: A Systematic Review [Internet].

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RESULTS

LITERATURE FLOW

The flow of articles through the literature search and screening process is illustrated in Figure 2. We identified 1101 unique citations from a combined search of MEDLINE (via PubMed, n=323), CINAHL (n=290), Embase (n=145), PsycINFO (n=157) and the Web of Science (n=186). Manual searching of included study bibliographies and review articles identified 2 additional citations for a total of 1104 citations. After applying inclusion/exclusion criteria at the title-and-abstract level, 95 full-text articles were retrieved and screened. Of these, 70 were excluded at the full-text screening stage, leaving 25 articles (representing 19 unique studies) for data abstraction. All studies compared shared medical appointments with usual care or enhanced usual care; there were no direct comparisons between types of quality-improvement strategies. Our search of www.clinicaltrials.gov did not suggest publication bias. There were no completed studies that were unpublished. We found four ongoing studies (Appendix F), one of which had a methods paper. Interestingly, in light of the narrowness of the medical conditions in which SMA has been tested, one study is on patients with heart failure.

Figure 2

Literature flow diagram for randomized controlled trials and observational studies on SMA. Abbreviations: KQ=key question; SMA=shared medical appointment

STUDY CHARACTERISTICS

Of the 19 studies, 16 (13 trials) evaluated SMA interventions in patients with diabetes mellitus and 3 (2 trials) evaluated SMAs in older adults with high utilization of medical resources. Most studies were conducted in primary care settings that are part of integrated health systems in the United States (Table 2). Of the 19 studies, 15 reported outcomes at 1 year or later. Detailed study characteristics are given in Appendix G.

Table 2

Overview of studies evaluating SMA.

Characteristics of Shared Medical Appointments

In the studies we assessed, SMAs were led by teams of 1 to 3 clinicians that included a physician (n=15), clinical pharmacists (n=9; the prescribing clinician in 3 studies) and a registered nurse (Table 3). The clinical team was multidisciplinary in most studies; pharmacists and licensed mental health professionals participated in almost half the studies. Sessions were designed for closed panels of patients in all but three studies; these later studies used drop-in models. Group size was 6 to 10 for most studies, with group size ranging between 10 and 20 in 4 studies and group size as large as 25 members in one study. The planned visit frequency ranged from approximately every 3 weeks to every 3 months. SMA visits were a median of 2 hours (range 1 to 3.5 hours).

Table 3

Characteristics of shared medical appointment interventions.

At least 16 of 19 studies offered individual breakouts with a physician or clinical pharmacist as part of the SMA design specified that medication changes could be made at group visits. Three studies did not report this information. About half the studies invited participation by family members or friends. Three studies described the educational approach as “patient-centered adult learning,”²⁰^–²² and two studies used the stages-of-change model to design the intervention;⁸^,²⁶ no other study described a theoretical model. In about half the studies, patients participated in selecting or prioritizing educational topics, and printed materials were tailored to the individual patient. Few studies used telephone contact as a part of the SMA intervention. Details of the SMA interventions are given in Appendix H.

Comparison Condition

In all studies, the comparison condition was some form of usual care. This care was inconsistently described. Three studies by one group²⁰^–²² and one other study¹⁸ used a structured or enhanced form of usual care. In one study,²² this care consisted of individual visits with a forced interval of 3 months; in another study,¹⁸ this was VA usual care supplemented with a single diabetes education session; and in the other two studies,²⁰^,²¹ usual primary care was enhanced by one-on-one education sessions with the group facilitator. Three studies conducted in the VA⁸^,²⁶^,³⁶ described usual care at some length, including average visit frequencies of 4 months, online clinical tools, electronic medical records with clinical reminders related to diabetes care, and a full range of referral services including diabetes education. Three other VA studies⁵^,¹⁴^,¹⁵ very briefly described usual care. The other nine studies did not describe usual care at all.

KEY QUESTION 1. For adults with chronic medical conditions, do shared medical appointments (SMAs) compared with usual care improve the following outcomes?

Patient and staff experience?
Treatment adherence?
Quality measures such as (a) process of care measures utilized by VA, National Quality Forum, or National Committee for Quality Assurance and (b) biophysical markers (laboratory or physiological markers of health status such as HbA1c and blood pressure)?
Symptom severity and functional status?
Utilization of medical resources or health care costs?

Effects of Shared Medical Appointments on Clinical, Process, and Economic Outcomes

The outcomes reported varied widely across studies and between studies for adults with diabetes and older adults. We describe the results separately for these two populations.

Effect of SMAs on Outcomes for Adults With Diabetes

Patient selection for SMA studies among patients with diabetes

Patient characteristics are reported in Table 4. Briefly, 10 of 15 studies required patients to be “out of control” with regard to their A1c; however, this inclusion floor varied from a low of 6.5% to a high of 9.0%. Four studies required elevated blood pressure, and two required elevated lipids. Other criteria were used by no more than two studies (e.g., efforts to assure that diabetes was type 2, insulin-requiring, high utilization in past year).

Table 4

Study details for SMAs enrolling adults with diabetes.

We identified 13 randomized trials that evaluated the effects of SMAs on outcomes for patients with diabetes.³^,⁸^,¹⁴^,¹⁵^,¹⁷^–²²^,²⁶^,³⁶^,³⁷ Of these, ten enrolled only patients with type 2 diabetes,³^,⁸^,¹⁴^,¹⁵^,¹⁷^,¹⁸^,²⁰^,²²^,²⁶^,³⁶ two enrolled mixed samples,¹⁹^,³⁷ and one enrolled only patients with type 1 diabetes.²¹ Three observational studies evaluated SMAs.⁵^,¹³^,¹⁶ All but one of these 16 studies compared SMAs with usual care. One study¹⁸ compared SMAs with a traditional, two-session, diabetes education intervention. Study quality was rated as good for 6 trials, fair for 6 trials and 2 observational studies, and poor for the two remaining studies. For trials, methodological problems included (1) failure to describe allocation concealment (n=9), (2) outcomes assessed without blinding to intervention (n=6), and (3) an inadequate approach to addressing incomplete data (n=6). Except for the study in patients with type 1 diabetes, patients were older adults with representative gender and racial mixes (Table 4).

Treatment Experience and Adherence Outcomes

Only two trials²¹^,³⁷ described the effects on patient experience, and none reported effects on staff experience. Neither of those trials showed greater satisfaction among those in SMAs compared with usual care. One study reported no effects on medication adherence,³ another reported no effects on blood glucose self-monitoring,²⁰ and two studies reported mixed effects on self-management behaviors.¹⁹^,³⁶ In both studies, patients in the SMA group increased the frequency of home glucose monitoring more than in the usual care group. Foot self-exams increased significantly in one study,³⁶ and exercise time increased by a statistically nonsignificant degree compared with usual care.

Effects on medication treatment were reported in 8 of 13 studies, but outcomes were reported inconsistently. One of four studies²⁶ reported more medication starts or dose titrations for oral hypoglycemic medications, and one of two studies⁸ reported more insulin starts and increased insulin doses for the SMA group. One of three studies²⁶ found more antihypertensive medication starts or dose titrations overall in the SMA intervention group, and two studies⁸^,¹⁵ found greater use of dose titrations for selected antihypertensive medications. Only one of five studies⁸ found a statistically significant increase in lipid-lowering medications and this was only for niacin. Most of the positive intervention effects were in studies led by clinical pharmacists. Patient or staff experience was not reported in any of the observational studies.

Biophysical Outcomes

Hemoglobin A1c. Figure 3 shows the forest plots for the random-effects meta-analyses of the effect of SMAs on glucose. All studies reported effects on average glucose (A1c) at the end of the intervention, assessed at 6 months to 4 years. SMAs were associated with lower A1c than usual care (mean difference=−0.55; 95% CI, −0.99 to −0.11). However, effects varied significantly across studies (Q=179.9, df=12, p < 0.001; I² =93%)—variability that was not explained by study quality. Because of the variability in effects between studies, we conducted analyses to evaluate this variability. First, we conducted a sensitivity analysis, excluding the study in patients with type 1 diabetes,²¹ but variability remained high (I²=94%). Next, we used meta-regression analyses to evaluate the association between baseline A1c and intervention robustness with treatment effects. Neither baseline A1c nor intervention robustness (B=0.02 decrease in A1c per 1 point increase in robustness; CI, −0.23 to 0.26) was associated with treatment effects (p=0.90). Thus, SMAs were associated with a mean decrease in A1c, but effects varied markedly and were not explained by factors we hypothesized a priori to be associated with variation in treatment effect.

Figure 3

Effects of shared medical appointments on hemoglobin A1c.

Effects of SMAs on glucose from the observational studies were generally consistent with the trial data. Two of the three observational studies⁵^,¹³ found statistically significant reductions in A1c from baseline to followup among patients participating in SMAs. Only one study⁵ compared this change with a control group, finding a statistically significant benefit from SMA participation (p=0.002).

Cholesterol. Figures 4 and 5 show the forest plots for the random-effects analyses of the effect of SMAs on total cholesterol (5 studies) and LDL cholesterol (5 studies). For both outcomes, SMAs were associated with a statistically nonsignificant decrease in cholesterol. For each outcome, treatment effects varied significantly across studies. Because of the small number of studies, we did not complete meta-regression analyses to examine variability in treatment effects. One additional study¹⁷ reported a statistically nonsignificant increase in the proportion of patients achieving an LDL of less than 100—findings that are consistent with the analysis of mean change in LDL. Only two of the observational studies reported effects on cholesterol. Both found reductions in LDL cholesterol, but only one⁵ compared the SMA with the control group, and the differences were not statistically significant.

Figure 4

Effects of shared medical appointments on total cholesterol.

Figure 5

Effects of shared medical appointments on LDL cholesterol.

Blood pressure. Figure 6 shows the forest plots for the random-effects analyses of the effect of SMAs on systolic blood pressure. Five studies reported effects on systolic blood pressure;³^,⁸^,²²^,²⁶^,³⁶ four of these were conducted in VA. SMAs were associated with improved blood pressure control (MD, −5.22; 95% CI, −7.40 to −3.05). Results were consistent across studies (Q=1.82, df=4, p=0.77, I²=0%). Of the three observational studies, only one⁵ found a statistically significant pre– post change in systolic blood pressure for the SMA participants. In this study, the blood pressure effects were also greater for the SMA group (−14.93 mmHg) than for the control group (−2.54 mmHg, p=0.04).

Figure 6

Effects of shared medical appointments on systolic blood pressure.

Health-Related Quality-of-Life Outcomes

Figure 7 shows the random-effects meta-analysis of the effect of SMAs on health-related quality of life (HRQOL). Six studies¹⁷^,²⁰^–²²^,³⁶^,³⁷ reported measuring HRQOL, but only five of these reported outcomes.²⁰^–²²^,³⁶^,³⁷ The studies by Trento et al. measured HRQOL with the Diabetes Quality-of-Life Measure, Cohen et al. reported the mental and physical components of the SF-36, and Wagner et al. reported the general health subscale of the SF-36. Because these measures differ, we analyzed the data using standardized mean difference. SMAs were associated with a large improvement in HRQOL (SMD −0.84; 95% CI, −1.64 to −0.03), but effects varied substantially across studies (Q=191.99, df=4, p<0.001; I²=98%). There were too few studies to evaluate the variability in treatment effects quantitatively. However, the studies with the smallest effects³⁶^,³⁷ used general rather than disease-specific measures.

Figure 7

Effects of shared medical appointments on health-related quality of life.

Economic Outcomes

Rates for hospital admissions and emergency department visits. The effect of SMAs on hospital admissions was reported in five studies.³^,¹⁴^,¹⁹^,²⁶^,³⁷ Four studies reported admission rates involving 603 patients followed for 6 to 18 months. In three of these, admission rates were lower with SMAs, but the result was statistically significant in only one study.¹⁹ The fifth study³⁷ followed 707 patients for 2 years and reported a statistically nonsignificant lower proportion of patients with a hospital admission who were randomized to SMAs (16.9% versus 21.0%, p=0.10).

Effects on emergency department visits were reported in the same five studies. Two studies reported significantly lower visit rates³ or the proportion with an emergency department visit.³⁷ Rates were not significantly different in the other three studies. Observational studies did not report comparative effects on admission rates or emergency department visits.

Costs. Four studies reported effects on total costs, one in a large HMO,³⁷ two in a university-affiliated general medical clinic serving low-income patients,¹⁴^,¹⁵ and another in an Italian diabetes clinic.²⁰ Findings were mixed. In the largest trial testing a low-intensity intervention,³⁷ the total health care costs (excluding the clinical study personnel) did not differ significantly. The studies by Clancy et al.¹⁴^,¹⁵ tested more robust interventions. The earlier study found significantly higher total costs (inpatient, outpatient, and emergency department costs) for SMAs compared with usual care ($2,886 versus $1,490 per patient over six months; p=0.0003). Total costs were heavily influence by higher inpatient costs for the SMA group. In the later study, 1-year charges were significantly lower for the SMA group ($5,869 versus $8,412 per patient, p<0.05). Lower modeled charges were driven primarily by lower outpatient charges, in particular for specialty visits. The study by Trento et al.,²⁰ conducted in Italy, reports costs that may not be applicable to the U.S. health system. An evaluation that included staff costs, medications, and transportation costs for diabetes care showed a small increase for SMA patients ($597 versus $570 over 4 years, p=NR). Observational studies did not report comparative costs.

Effect of SMAs on Outcomes for Older Adults

Patient selection for SMA studies among older adults

Only three studies evaluated SMA interventions in older adults. Two of the four studies required a minimum age of 60; the other two used 65. All studies required some elevated use of health care in the past year; two operationalized that directly, while the third required a hospitalization in the past year.

We identified two randomized trials⁹^,¹¹ that evaluated the effects of SMAs in 615 older adults with a recent hospitalization or other criteria for increased utilization. One observational study evaluated a similar population of 2251 older adults.¹⁰ All studies were conducted in primary care, in group-model HMO settings in the United States, and compared SMAs with usual care. The mean age of participants ranged from 73.5 to 78.2 years of age. The most common chronic conditions were arthritis, hypertension, difficulty hearing, heart disease, liver disease, and bladder/kidney disease. All studies reported effects on utilization or costs at 1 year or greater. One trial was rated fair quality¹¹ and one poor quality;⁹ the observational study was rated fair quality.¹⁰ In the trial by Scott et al.,¹¹ only participants expressing a strong interest in group care (37% of those eligible) were randomized. Methodological problems included failure to describe allocation concealment, outcomes assessed without blinding to intervention, and poor specification of outcome measures. Additional study details are in Appendix G.

The design of SMA visits was similar to the diabetes studies, except that fewer disciplines participated in the clinical teams. Detailed intervention descriptions are in Appendix H.

Treatment Experience and Adherence Outcomes

All studies reported a measure of patient experience. The two trials reported patient perceptions of quality of care, and both reported higher quality ratings with SMAs compared with usual care. In the study by Beck et al.,⁹ more patients rated the overall quality of care as excellent (37% versus 27%, p=0.019), and Scott et al.¹¹ found that patients assigned to SMAs rated the quality of care 0.3 points higher on a 1-to-4 scale than usual care patients did (p=0.048). In the observational study, only SMA participants rated satisfaction, and 90 percent of participants reported satisfaction with four aspects of group visits, including the visit overall. In aggregate, these results support high levels of satisfaction with group visits among older adults. No study evaluated staff satisfaction using a validated measure, and no study reported comparative data on medication adherence. In the study by Levine et al.,¹⁰ 90 percent of SMA providers agreed or strongly agreed that they felt a lot of satisfaction from group visits, and 50 percent endorsed that group visits enhance their practice. Beck et al.⁹ reported that participants attended 55 percent of scheduled SMA visits. Among participants with a high interest in group visits, Scott et al.¹¹ reported 2 or fewer visits over 24 months by approximately 25 percent of patients.