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临床试验/NCT04766619
NCT04766619Unknown不适用

Generating Recommendations for National Roll-out and Sustainable Use of Prescribing Safety Indicator Based Interventions Using Longitudinal Process Evaluation and a Consolidated Learning Exercise

University of Nottingham3 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2018年2月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
390
试验地点
3
主要终点
Primary Objective 1. Impact of influential factors in translation, implementation and sustained use of the OptimiseRx and PINCER interventions in the short-term, medium-term or long-term.

研究概览

简要总结

This study aims to evaluate two interventions designed to make medication prescribing safer, OptimiseRx and PINCER, which are being used in general practices across England. The findings from the evaluation will be used to generate recommendations as to how these interventions can be used sustainably in the long-term.

详细描述

This study has been designed to evaluate and gain an understanding of the 'real world' implementation, fidelity and medium and longer-term embedding and sustainability of two prescribing safety interventions: the computerised decision support (CDS) tool - Optimize Rx, and PINCER (pharmacist-led information technology intervention for reducing clinically important errors in medication management). The longitudinal process evaluation will involve observations, interviews, focus groups and questionnaires. The consolidated learning exercise, which aims to inform long-term, sustainable intervention use will involve a documentary analysis, interviews, focus groups, development workshops and a synthesis of the evaluation results.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Staff and stakeholders
  • Able to give written informed consent
  • 18 years of age or over (no maximum age limit)
  • Staff members working in/for a practice or a CCG or the software developer which has received the intervention/s and have direct contact with it/them
  • Staff from relevant AHSNs, NHS England, the University of Nottingham or PRIMIS and other relevant staff who have had involvement in the PINCER rollout
  • Staff who have either had direct contact with, have an understanding of and/or are in a position to influence wider adoption of the PINCER and OptimseRx interventions (e.g. contracting, IT systems engineer, commissioner, etc.)
  • Able to give written informed consent
  • 18 years of age or over (no maximum age limit)
  • Patients registered with a general practice who have attended a consultation (or other related activity) for the PINCER intervention, or selected by their clinical care team, or attached to a patient group within a CCG or practice or those identified via social media who are living with a long-term health condition and/or who require regular blood tests to monitor their medication and have had a medication review within the past six months
  • Members of the public and patient representatives
  • Able to give written informed consent
  • 18 years of age or over (no maximum age limit)
  • Those who have either had direct contact with the PINCER intervention or have an understanding of the related medicines management issues in primary care

排除标准

  • Staff and stakeholders
  • Unable to give written informed consent
  • Under 18 years of age
  • Unable to give written informed consent
  • Under 18 years of age
  • Those considered by their healthcare professional to be inappropriate to recruit due to psycho-social reasons or significant health reasons, e.g. terminal illness/diagnosis.
  • Members of the public and patient representatives
  • Unable to give written informed consent
  • Under 18 years of age

结局指标

主要结局

Primary Objective 1. Impact of influential factors in translation, implementation and sustained use of the OptimiseRx and PINCER interventions in the short-term, medium-term or long-term.

时间窗: Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation

Semi-structured interviews, focus groups and a questionnaire survey will be conducted to evaluate the contextual factors that influence the nature and extent of translation, implementation and sustained use of the PINCER intervention and prescribing safety indicator (PSI) functions, in particular, across different Academic Health Science Networks (AHSNs) and CCGs over prolonged time periods.

Primary Objective 2. Fidelity of the PINCER intervention delivery and variations in success over time.

时间窗: Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation

Semi-structured interviews, focus groups and a questionnaire survey will be conducted to evaluate how the PINCER intervention has been delivered, experienced and has evolved over time in diverse contexts to achieve different degrees of success with particular reference to PSIs.

次要结局

  • Secondary Objective 1. Impact and sustained delivery of the PINCER intervention and potential complementary use of OptimseRx and PINCER.(Short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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Process Evaluation of OptimiseRx and PINCER | 临床试验