Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.
School of Business and Economics Center for Health Economics and Health Services Research, University of Wuppertal, D-42119, Wuppertal, Germany.
BMC Palliat Care. 2024 Mar 21;23(1):77. doi: 10.1186/s12904-024-01404-8.
Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences.
The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups.
Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up.
The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions.
German Clinical Trials Register: DRKS00016886 on 04/06/2019.
为了全面了解预先医疗照护计划的过程，应当对预先医疗照护计划干预措施进行尽可能广泛的评估。然而，目前缺乏经过验证的早期阶段结果评估工具。因此，作为集群随机对照试验 STADPLAN（依赖护理的社区居住老年人的预先医疗照护计划研究）的一部分，开发并验证了治疗偏好评估-预先医疗照护计划（Treat-Me-ACP）工具，以评估预先医疗照护计划干预措施对患者医疗治疗偏好的影响。
Treat-Me-ACP 的设计基于伊曼纽尔医疗指令和生命支持偏好问卷。通过多阶段团队方法，开发并预测试了初步版本的 Treat-Me-ACP。预测试工具包括一个整体医疗目标项目、五个具有五个假设治疗方案的假设场景，以及每个场景内的一个“您会如何感受”项目。总共可以形成五个方案偏好评分和五个治疗偏好评分。随后，该版本应用于 STADPLAN 项目的一个子样本（n=80）中，以评估患者在基线（T0）和 12 个月随访（T2）时的偏好。进一步的验证步骤基于该子样本，包括：（1）通过完成率和缺失数据频率接受评估；（2）通过 Cronbach's α 进行内部一致性评估，以检验是否可以通过方案和治疗来创建偏好评分；（3）通过关联整体医疗目标项目和偏好评分，以及关联“您会如何感受”项目和方案偏好评分，进行同时验证；（4）通过比较研究组之间 T0 至 T2 期间对维持生命治疗的偏好评分，评估工具对治疗偏好变化的反应能力。
工具的接受程度很高。同时验证的结果表明，五个场景很好地代表了整体医疗目标。在研究随访期间，干预组的所有量表上，对维持生命治疗的偏好呈平均下降趋势。
Treat-Me-ACP 可用于评估预先医疗照护计划中患者医疗治疗偏好的动态变化。它已经过依赖护理的社区居住老年人的验证，可以作为评估预先医疗照护计划干预措施效果的附加结果评估工具。
德国临床试验注册处：DRKS00016886，于 2019 年 6 月 4 日。
