PDF(Pubmed)
Abstract：
UNASSIGNED: Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants.
UNASSIGNED: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability.
UNASSIGNED: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed. The primary feasibility outcome was percentage of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semistructured interviews.
UNASSIGNED: Among 47 eligible patients, 35/47 (74.5%; 95% CI, 58.6%-85.7%) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%; 95% CI, 16.9%-64.7%) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet\'s purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%; 95% CI, 26.4%-75.4%), which was lower for surgeons than nonsurgeons (22.7% vs 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable.
UNASSIGNED: The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.
UNASSIGNED: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability.
UNASSIGNED: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed. The primary feasibility outcome was percentage of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semistructured interviews.
UNASSIGNED: Among 47 eligible patients, 35/47 (74.5%; 95% CI, 58.6%-85.7%) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%; 95% CI, 16.9%-64.7%) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet\'s purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%; 95% CI, 26.4%-75.4%), which was lower for surgeons than nonsurgeons (22.7% vs 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable.
UNASSIGNED: The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.
摘要：
■过度使用抗血小板治疗和未充分使用胃保护会导致服用抗凝剂的患者发生可预防的出血。
■（1）确定一项析因试验测试患者激活和临床医生外展的可行性，以降低未使用质子泵抑制剂胃保护的华法林抗血小板治疗患者的胃肠道（GI）出血风险；（2）评估干预的可接受性。
■进行了务实的2×2阶乘群集随机对照试验，比较了（1）患者激活手册与常规护理和（2）临床医生通知与临床医生通知加护士促进。主要可行性结果是5周后完成结构化电话评估的患者百分比。探索性结果，包括有效性，使用图表审查进行评估，调查,半结构化面试。
■在47名符合条件的患者中，35/47（74.5%；95%CI，58.6%-85.7%）符合可行性结果。在被证实为上消化道出血高风险的子集中，11/29（37.9%；95%CI，16.9%-64.7%）改变了用药，干预武器之间没有差异。在采访中,少数患者报告查看了激活手册；障碍包括低估胃肠道出血风险，误解了这本小册子的目的，收到过多的健康传播材料。临床医生对24/47名患者的通知信息做出了回应（51.1%；95%CI，26.4%-75.4%），外科医生低于非外科医生(22.7%vs76.0%)。医学专家而不是外科医生认为临床医生通知是可以接受的。
■提出的试验设计和结果确定策略是可行的，但是患者激活干预不太可能像设计的那样有效。虽然临床医生的通知似乎很有希望，外科医生可能无法接受，这些发现支持进一步完善和测试临床医生通知干预措施。
■（1）确定一项析因试验测试患者激活和临床医生外展的可行性，以降低未使用质子泵抑制剂胃保护的华法林抗血小板治疗患者的胃肠道（GI）出血风险；（2）评估干预的可接受性。
■进行了务实的2×2阶乘群集随机对照试验，比较了（1）患者激活手册与常规护理和（2）临床医生通知与临床医生通知加护士促进。主要可行性结果是5周后完成结构化电话评估的患者百分比。探索性结果，包括有效性，使用图表审查进行评估，调查,半结构化面试。
■在47名符合条件的患者中，35/47（74.5%；95%CI，58.6%-85.7%）符合可行性结果。在被证实为上消化道出血高风险的子集中，11/29（37.9%；95%CI，16.9%-64.7%）改变了用药，干预武器之间没有差异。在采访中,少数患者报告查看了激活手册；障碍包括低估胃肠道出血风险，误解了这本小册子的目的，收到过多的健康传播材料。临床医生对24/47名患者的通知信息做出了回应（51.1%；95%CI，26.4%-75.4%），外科医生低于非外科医生(22.7%vs76.0%)。医学专家而不是外科医生认为临床医生通知是可以接受的。
■提出的试验设计和结果确定策略是可行的，但是患者激活干预不太可能像设计的那样有效。虽然临床医生的通知似乎很有希望，外科医生可能无法接受，这些发现支持进一步完善和测试临床医生通知干预措施。
