Table 1.
Overview of Studies Identified Through the Literature Search for Inclusion in the Systematic Review
| Article | Participant Characteristics and Study Duration | Interventions | Study Design | Major Findings |
|---|---|---|---|---|
| Benson et al., 2018 (United States) (13) | 1,028 patients aged 40–79 years at increased CVD risk without active CVD or diabetes (326 participants compared with 702 eligible nonparticipants). Study duration: 6–12 months | Primary prevention telemedicine program to reduce CVD risk; dietitians and nurses delivered health coaching and medication therapy protocols for dyslipidemia and HTN via monthly calls. | Retrospective cohort study | 83% engagement after 6 months. More participants than nonparticipants quit using tobacco (7.0 vs. 3.2%, P = 0.004) and achieved LDL goal <100 mg/dL (8.9 vs. –1.1%, P = 0.009). Participants with five or more encounters improved TC and LDL more than those with fewer encounters (P <0.05). |
| Benson et al., 2019 (United States) (14) | 118 patients with T2D recruited from two rural primary care clinics (intervention [n = 60] compared with control/usual care [n = 58]). Study duration: 1 year | Via a telemedicine program, dietitians used a medication protocol to initiate and titrate therapies for diabetes, HTN, and dyslipidemia and provide lifestyle coaching. | RCT | 88% completion rate. The intervention group increased from a mean of meeting 3.1 to 3.7 optimal care goals compared with the control group, which had a smaller increase from a mean of 2.8 to 3.2 optimal care goals (P = 0.017). The intervention group had increased medication use, with ORs of 2.5 and 2.2 of taking a statin (95% CI 1.0–6.24) and aspirin (95% CI 0.90–5.19), respectively. |
| California Medi-Cal Type 2 Diabetes Study Group, 2004 (United States) (15) | 362 Medicaid recipients with T2D, 52% of whom were minorities (intervention [n = 186] compared with control/usual care [n = 172]). Study duration: 36 months | Nurses and dietitians provided diabetes case management, including lifestyle strategies to improve self-care and evidence-based practice guidelines/ algorithms for diabetes medication and insulin initiation and/or adjustment used in collaboration with a PCP. | RCT | 88% completion rate. A1C decreased in both groups from a mean of 9.54 to 7.66% (decrease of 1.88%) in the intervention group and a mean of 9.66 to 8.53% (decrease of 1.13%) in the control group. A1C decrease was greater in the intervention group at each time point (P <0.001), ranging between 0.65 at 6 months and 0.87 at study end. |
| Courtenay et al., 2015 (United Kingdom) (16) | 214 patients with T2D in six general practices with nurse prescribers (n = 131) compared to six practices with diabetes care provided by nurse nonprescribers (n = 83). Study duration: 6 months | Nurse prescribers made face-to-face or telephone visits to recommend, amend, stop, or prescribe diabetes medications. Other than medication adjustments, there were no significant differences in diabetes care provided by prescribers and nonprescribers. | Prospective cohort study | 87% completion rate. There was a significant decrease in A1C across patients of both prescribing (−2.1 mmol/mol mean change) and nonprescribing (−4.6 mmol/mol mean change) nurses; however, there was no statistically significant change between groups. |
| Fanning et al., 2004 (United States) (17) | 443 patients with T2D diagnosed within the past year; 358 were adherent and included in the final analysis (90% Mexican American from low-income neighborhoods). Study duration: 1 year | Nurses used treatment algorithms for diabetes, dyslipidemia, and HTN; community clinic with treatment algorithms (CC-TA) and university clinic with treatment algorithms (UC-TA) versus community clinic with standard care (CC-SC). Treatment algorithm groups were given glucose meters, logs were reviewed, and diabetes classes were emphasized. | Prospective cohort study (no comparison group) | 81% completion rate. Decreases in A1C in CC-TA and UC-TA were 3.1 and 3.3%, respectively, versus 1.3% in CC-SC (P <0.0001). Decreases in fasting plasma glucose were 94 and 99 mg/dL, respectively, versus 38 mg/dL in CC-SC (P <0.0001). Decreases in TC, LDL, and triglycerides were greater in both algorithm-managed clinics versus standard care management (P <0.0001). All three clinics were equally effective for BP management. |
| Furler et al., 2017 (Australia) (18) | 266 patients with T2D from 74 general practices (control/usual care arm [n = 115] compared with intervention arm (n = 151]). Study duration: 1 year | Practice nurses (mentored by an RN/CDE) used simple clinical protocols to initiate and up-titrate insulin. | RCT | 84% completion rate. Intention-to-treat analysis found A1C improved in both arms, with a mean difference of −0.6% (95% CI −0.9 to −0.3) favoring intervention. 70% of intervention patients started insulin versus 22% in the control group (95% CI 4.5–15.4, P <0.001). Target A1C (≤7%) was achieved by 36% in the intervention group and 19% in the control group (P = 0.02). |
| Houweling et al., 2011 (the Netherlands) (19) | 230 patients with T2D (randomized to either practice nurse group [n = 116] or standard care from a general practitioner [n = 114]). Study duration: 14 months | Nurses used a detailed treatment protocol aimed to optimize glucose, BP, and lipids, along with eye and foot care. | RCT | 90% completion rate. Between-group differences for A1C, BP, and lipids were not statistically significant. BP decreased significantly in both groups. SBP −7.4 mmHg (95% CI −3.8 to −10.9) and DBP −3.2 mmHg (95% CI −1.3 to −5.2) in the intervention group and SBP −5.6 mmHg (95% CI −2.3 to −8.8) and DBP −1.0 mmHg (95% CI −0.8 to −2.8) in the control group. In both groups, more patients met the target goals for lipids compared with baseline. Patients treated by nurses were more satisfied. |
| Houweling et al., 2009 (the Netherlands) (20) | 93 patients with T2D referred by a PCP (randomized to intervention with a nurse specialist in diabetes [NSD] [n = 50] or usual care with an internist [n = 43]). Study duration: 1 year | Nurse-led patient education + detailed BG, BP, and lipid treatment protocols | RCT | 90% completion rate. No statistically significant difference between NSD and usual care groups for A1C, BP, TC, or LDL. Only statistically significant difference between groups was for TC/HDL ratio (P = 0.034). At 1 year, A1C was <7% in 33.3% of NSD group (P = 0.002), but there was no statically significant difference between groups. Health care costs decreased and patient satisfaction increased with nurse-led intervention (P <0.001), with same quality of life maintained. |
| MacMahon et al., 2009 (Ireland) (21) | 200 patients with T2D who failed to meet recommended BP and/or TC targets after intervention in the hospital diabetes clinic (randomized to intensive [n = 101] or standard [n = 99] care). Study duration: 1 year | Patients randomized to intervention met with a diabetes nurse specialist every 2–3 months for lifestyle advice and medication titration for BP, BG, and lipids to achieve ADA guidelines. | RCT | 94% completion rate. More patients in the intervention group achieved targets than in standard care; SBP (<130 mmHg) 33 versus 12.1% (P <0.001); TC (<4.8 mmol/L) 84.8 versus 63.6% (P <0.001); LDL (<2.6 mmol/L) 73.4 versus 54.5% (P = 0.007); and A1C (<6.5%) 53.2 versus 32.9% (P = 0.005). |
| McLoughney et al., 2007 (United Kingdom) (22) | 96 patients with T2D and uncontrolled HTN or HLD (compared at baseline vs. program completion). Study duration: 1 year | Treatment protocol–driven, doctor- supervised, specialist nurse–led intervention clinic. Patients met with nurse every 3–4 weeks to discuss lifestyle and medication action plan. BP and lipid medications were titrated according to treatment response and study protocol. | Prospective cohort study (no comparison group) | 98% completion rate. Statistically significant decrease in SBP (167 ± 12 vs. 132 ± 8 mmHg, P <0.001) and DBP (85 ± 9 vs. 70 ± 7 mmHg, P <0.001). 92% achieved target BP. TC (6.0 ± 1.2 vs. 3.9 ± 0.7 mmol/L, P <0.001) and triglycerides (4.2 ± 0.8 vs. 2.4 ± 1.2 mmol/L, P <0.001) significantly improved. 91% achieved target lipids. Mean A1C level improved (8.5 ± 1.5 vs. 7.4 ± 1.5%, P <0.01), and 45% achieved an A1C <7%. |
| New et al., 2003 (United Kingdom) (23) | 1,407 patients with T1D or T2D presenting for annual review with BP ≥140/80 mmHg and/or TC ≥5.0 mmol/L (randomized to specialist nurse intervention or standard care). Study duration: 1 year | Patients attended nurse-led HTN and/or HLD clinic every 4–6 weeks until targets were achieved with medication titration using protocols, along with individualized lifestyle action plan and diabetes education. | RCT | 82 and 92% completion rates for HTN and HLD clinics, respectively. The nurse-led clinics had statistically significant improvements in patients achieving targets compared with standard care (OR 1.37 [95% CI 1.11–1.69], P = 0.003). |
| Ogedegbe et al., 2018 (Ghana) (24) | 757 patients with uncontrolled HTN received health insurance coverage (HIC) only (n = 389) compared with nurse-led medication protocol for HTN (TASSH) + HIC (n = 368). Study duration: 12 months | Trained community health nurses implemented a cardiovascular risk assessment, provided counseling on lifestyle modification, and initiated and titrated antihypertensive medications. | RCT | 85% completion rate. Intention-to-treat analysis for all enrolled patients. TASSH + HIC group had a greater SBP reduction (−20.4 mmHg, 95% CI −25.2 to −15.6) than the HIC-only group (−16.8 mmHg, 95% CI −19.2 to −15.6), with a statistically significant between-group difference of −3.6 mmHg (95% CI −6.1 to −0.5; P = 0.021). |
| Rudd et al., 2004 (United States) (25) | 150 patients with BP ≥150/95 mmHg needing drug therapy for HTN (randomized to nurse care management intervention + usual care [n = 74] or usual care only [n = 76]). Study duration: 6 months | For the intervention group, nurses titrated medications using algorithms, and patients monitored BP with a home monitoring device. Nurses contacted physicians to initiate new drugs. | RCT | 91% completion rate. The intervention group had a decrease in SBP by 14.2 mmHg (95% CI −18.1 to −10.0) versus 5.7 mmHg (95% CI −10.2 to −1.3) in the usual care group (P <0.01). DBP decreased by 6.5 mmHg (95% CI −8.8 to −4.1) compared with 3.4 mmHg in usual care group (95% CI −5.3 to −1.5) (P <0.05). |
| Senaratne et al., 2001 (Canada) (26) | Phase 1: intervention group (n = 80) + usual care control group (n = 189); Phase 2: all intervention group (n = 366). Study duration: 6 months | Cardiac rehabilitation nurse ordered lipid panels and used a pharmacologic treatment algorithm to initiate cholesterol-lowering medication therapy. Both groups had the same dietary counseling option. | Prospective cohort study | 100% of patients were included in the analysis. Outcomes for control and intervention groups at baseline versus 1 year, respectively: TC 5.47 ± 0.08 to 4.92 ± 0.06 versus 5.42 ± 0.13 to 4.6 ± 0.07 mmol/L; LDL 3.44 ± 0.07 to 2.91 ± 0.06 versus 3.43 ± 0.11 to 2.68 ± 0.07 mmol/L; and on medication 49 versus 83% (P = 0.01). Phase 2 intervention across all patients continued to show improved results relative to the phase 1 control group. |
| Senior et al., 2008 (Canada) (27) | 424 with T2D or T1D (n = 46) with HTN or albuminuria who attended the initial visit and returned for ≥1 follow-up visit. Study duration: 6 months | Nurse or dietitian provided lifestyle counseling and medication initiation and titration for BP, lipids, and glycemic control. | Prospective cohort study (no comparison group) | 99% completion rate. BP, A1C, and LDL improved at follow-up (SBP from 133 ± 19.3 to 129 ± 16.6 mmHg; DBP from 74 ± 11.3 to 71 ± 9.7 mmHg; A1C from 8.1 ± 1.9 to 7.5 ± 1.3%; LDL from 104 ± 35 to 93 ± 31 mg/dL; P <0.0001 for all). |
| Taylor et al., 2012 (New Zealand) (28) | 100 patients with resistant HTN (clinical nurse specialist [CNS] HTN clinic participants [n = 50] and physician HTN clinic patients [n = 50]). Study duration: up to 10 months | Patients seen in CNS clinic every 2–4 weeks until target BP reached. Lifestyle and risk factor education plus medication adjustments made according to pre-arranged algorithms. | Prospective cohort study | 100% of patients were included in the analysis. Significant decrease in both SBP and DBP for physician HTN clinic patients (−20 mmHg SBP and −13 mmHg DBP), as well as CNS HTN clinic patients (−30 mmHg SBP and −14 mmHg DBP) (P <0.01). SBP reduction was larger in the CNS clinic group (P = 0.02). |
| Tobe et al., 2006 (Canada) (29) | 99 First Nations patients with T2D and HTN (randomized to home nurse intervention [n = 50] or usual care with physician [n = 49). Study duration: 1 year | Home care nurse followed approved treatment protocol for HTN therapy to reach target BP <130/80 mmHg. Both groups received healthy lifestyle classes. | RCT | 91% completion rate. In both groups, change in BP from baseline to final visit was statistically significant. SBP decreased 7.0 mmHg more in the intervention group than in the control group (P = 0.14). DBP decreased 4.8 mmHg more in the intervention group than in the control group (P = 0.05). |
| Worth et al., 2006 (United Kingdom) (30) | 110 consecutive patients with T1D (n = 12) or T2D (n = 97) and dyslipidemia who had at least three clinic visits were included. Study duration: 1 year | Diabetes dietitian provided lifestyle coaching and followed protocol to recommend, monitor, and titrate statin monotherapy or combined statin and fibrate therapy. | Time series (with pre-/post- comparison) | 85% completion rate. TC decreased from a mean of 241 mg/dL (95% CI 235–247) to 169 mg/dL (95% CI 166–172) (P <0.001). Triglycerides decreased from 268 mg/dL (95% CI 229–307) to 184 mg/dL (95% CI 166–203) (P <0.001). Reductions were maintained after 1 year. |
| Yip et al., 2018 (China) (31) | 393 patients with HTN (randomized to nurse-led intervention [n = 194] or usual care [n = 199]). Study duration: 1 year | The nurse-led repeated prescription (NRP) group saw physician at baseline and 12 months, and the nurse used an HTN management protocol at 4 and 8 months. | RCT | 98% completion rate. Baseline-adjusted modified intention-to-treat and pre-protocol mean differences (between NRP and usual care) for SBP were 0.53 mmHg (95% CI −2.05 to 3.11) and 0.43 mmHg (95% CI −2.16 to 3.02), respectively. For DBP, the mean differences were 1.23 mmHg (95% CI −0.27 to 2.73) and 1.16 mmHg (95% CI −0.35 to 2.67), respectively. There were no significant differences between the NRP and usual care groups with regard to BP at 1 year, after adjusting for baseline values. |
| Zgibor et al., 2018 (United States) (32) | 240 patients with T2D for ≥1 year and an A1C ≥7% or LDL ≥100 mg/dL or BP ≥130/80 mmHg from 15 primary care practices (intervention [n = 175] compared with usual care [n = 65]). Study duration: 1 year | Implementation of pre-approved diabetes management protocol with diabetes education by nurse CDEs during visits at baseline and 3, 6, and 12 months. Usual care included invitation to monthly CDE-led support group. | RCT | 90% completion rate. Mean difference in A1C between intervention and usual care was −0.66 (95% CI −1.11 to −0.22; P = 0.004), after adjustment for baseline A1C and other demographics and clinical factors. There were no statistically significant differences between groups for LDL or SBP. |
BG, blood glucose; BP, blood pressure; CDE, certified diabetes educator; CVD, cardiovascular disease; DBP, diastolic blood pressure; HDL, HDL cholesterol; HLD, hyperlipidemia; HTN, hypertension; LDL, LDL cholesterol; OR, odds ratio; SBP, systolic blood pressure; T1D, type 1 diabetes; T2D, type 2 diabetes; TC, total cholesterol.