Veterans Affairs Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.
Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
J Gen Intern Med. 2021 Jun;36(6):1648-1655. doi: 10.1007/s11606-020-06570-y. Epub 2021 Feb 2.
To examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements.
A multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8-9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs.
Baseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group.
Diabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention.
ClinicalTrials.gov ID NCT02132676.
研究在不同医疗体系中实施的作为常规临床实践一部分的糖尿病联合门诊(SMA)是否比常规护理更能有效改善和维持 A1c 的改善。
这是一项多地点集群随机实用试验,于 2016 年至 2020 年在五个退伍军人事务部(VA)医疗系统中对临床实践中实施的糖尿病 SMA 进行了研究,共有 1537 名 2 型糖尿病和 A1c 升高的成年人参与。符合条件的患者被随机分配到以下两种治疗方式之一:(1)受邀参加一系列总计 8-9 小时的 SMA;或(2)继续接受常规护理。A1c(主要结局)和收缩压、胰岛素起始、他汀类药物起始和抗高血压药物类别(次要结局)的相对变化作为基线、6 个月和 12 个月(五个地点中的四个在最后一次 SMA 结束后约 7 个月)常规临床护理的一部分进行测量。我们在三个 SMA 参与者样本中检查了结果:所有计划参加 SMA 的患者、至少参加一次 SMA 的患者和至少参加一半 SMA 的患者。
基线平均 A1c 为 9.0%。与对照组相比,计划参加 SMA 的患者在基线和 6 个月随访时 A1c 降低了 0.35%(p=0.001)。至少参加一次 SMA 的患者降低了 0.42%(p<0.001),至少参加一半计划 SMA 的患者降低了 0.53%(p<0.001)。在 12 个月随访时,三个 SMA 分析样本与对照组相比,从基线的降幅范围为 0.16%(p=0.12)至 0.29%(p=0.06)。
在真实多样的临床实践中实施的糖尿病 SMA 比常规护理更能立即改善血糖控制,但相对改善并未维持。我们的研究结果表明,需要进一步研究是否采用更长期的 SMA 模式或其他后续策略来维持与该干预相关的临床改善。
ClinicalTrials.gov 编号 NCT02132676。