Implementation of a Diagnostic Decision-aid for People With Memory Complaints and Their General Practitioners: a Study Protocol of a Before and After Mixed-method Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The course of the decision-making process (free text notes)
研究概览
简要总结
In a mixed-methods design the investigators will study decision making processes and experiences regarding a diagnostic trajectory before and after the introduction of a patient decision aid for people with memory complaints, their significant others and their GPs. The 'before group' will receive diagnostics as usual from their GPs. The 'after group' will use the patient decision aid. The investigators expect the patient decision aid to increase the level of SDM and to contribute to a timely and personalized diagnostic trajectory. Data will be collected using semi-structured interviews, questionnaires and information retrieved from people with memory complaints' medical records.
详细描述
Study design This study will use a before-after mixed-methods design. In the before group (BG) GPs will execute care as usual in the decision-making process for a diagnostic trajectory for memory complaints. In the after group (AG), a patient decision aid will be added to the decision-making process provided by the GP. The same GPs will participate in both the BG and the AG, which maximizes the comparability between the BG and the AG. The investigators aim to use the mixed-methods approach to gain a broad and in-depth understanding of the issues important for people with memory complaints, their significant others, and the GPs involved in the decision-making process. This approach is taken to fully unravel the complexity of the decision-making process for a diagnostic trajectory for memory complaints and of the SDM intervention.
Setting The study was developed by Maastricht University Medical Centre (MUMC+) in close collaboration with Radboud University Medical Center Nijmegen (Radboudumc Nijmegen). The participating GPs, people with memory complaints and their significant others will be recruited from general practices located in the south-eastern part of the Netherlands.
Participants Patient involvement Before the start of the study, a client panel of the Alzheimer Centre Limburg (i.e. a panel consisting of people with dementia and their significant others) was asked to reflect on the research design. During the study, people with memory complaints and their significant others will be closely involved in the development and implementation of the SDM-intervention.
Recruitment and study participants First, the researchers will approach GPs working in the south-eastern part of the Netherlands with an information letter about the study. No specific inclusion and exclusion criteria have been formulated for the GPs. GPs who want to participate will be asked to return an application form to the research team. Subsequently, the research team will then provide participating GPs with study material (patient application forms, information letters, and informed consent forms). GPs will be asked to recruit patients with memory complaints during an inclusion period of 6 months in both the before and after group. In the before group, the GPs will inform potential participants about the study after a decision about a diagnostic trajectory (i.e. to wait and see, undergo diagnostic testing by the GP, or referral to a medical centre) has been made. Patients can be included up to a maximum of 3 months after a decision has been made. Significant others of people with memory complaints will be asked to participate as well; their participation is preferred, but not required. The inclusion and exclusion criteria of the study are shown in Table 1. If a potential participant is interested in the study, the GP will send his/her contact details to the researchers. The researchers will contact the potential participant to provide detailed information about the study. Eligible participants will sign informed consent forms before participation. The inclusion/consent procedure in the after group will be finalized based on the developed intervention in a later stage of the study.
Sample size Given the dependence between patients and their GPs in our sample, clustering of patients per GP was taken into account in sample size calculations. Clusters were expected to include at least two people with memory complaints and intraclass correlation to be 0.05 or lower. To achieve power of 0.8 and 2-sided testing at 0.05, 35 GPs are required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person has visited the general practitioner because of memory complaints no longer than 3 months ago (noticed by the person, a significant other and/or the general practitioner)
- •Person is above the age of 60
- •Person is able to complete baseline assessments
- •Person must be mentally competent
- •Person must give written informed consent prior to participation
排除标准
- •Person has communication/language/comprehension/literacy or (severe) hearing problems
- •Person has had a severe mental illness in the last 12 months, such as schizophrenia, depression or a bipolar disorder not otherwise specified
- •Person has a life-threatening comorbid illness
结局指标
主要结局
The course of the decision-making process (free text notes)
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
The course of the decision-making process will be explored through retrospectively studying 'free text' notes in the medical record of the person with memory complaints.
The course of the decision-making process (number of consultations)
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
The course of the decision-making process will be explored through retrospectively studying the number of consultations needed to achieve the final decision and through studying 'free text' notes in the medical record of the person with memory complaints.
Experiences during the decision-making process (people with memory complaints)
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
The decision-making process in general practice will be explored with semi-structured interviews (by telephone or face to face) with people with memory complaints Questions will focus on their experiences, considerations, preferences, and expectations during the decision-making process.
Perceived shared decision-making
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
To assess shared decision-making during the decision-making process, people with memory complaints (and their significant others) will be interviewed about their experienced level of SDM and preferences regarding SDM. Their GPs will be asked to complete questionnaires about the level of SDM and their self-efficacy regarding SDM
Final outcome of the decision-making process
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
The outcome of the decision-making process, that is, to wait and see, undergo diagnostic testing by the GP, or referral to a medical centre will also be obtained from the medical record of the person with memory complaints.
Experiences during the decision-making process (general practitioners)
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
The decision-making process in general practice will be explored with semi-structured interviews (by telephone or face to face) with general practitioners. Questions will focus on their experiences, considerations, preferences, and expectations during the decision-making process.
Experiences during the decision-making process (significant others of people with memory complaints)
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
The decision-making process in general practice will be explored with semi-structured interviews (by telephone or face to face) with significant others of people with memory complaints. Questions will focus on their experiences, considerations, preferences, and expectations during the decision-making process.
Level of shared decision-making
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
Level of SDM will be assessed by using the Dutch version of the Shared Decision-Making Questionnaire - Doc (SDM-Q-Doc). This 9-item SDM-Q-Doc focusses specifically on the GP's perspective of the SDM process. The questionnaire has six-level response options (0 = completely disagree to 5 = completely agree), where higher scores indicate more SDM.The scale has been shown to have good internal consistency and acceptance and acceptable-to-good convergent validity in a sample of physicians.
Self-efficacy regarding shared decision making
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
Self-efficacy regarding SDM will be assessed via a Visual Analogue Scale (VAS). GPs have to indicate the level of SDM during the last consultation with the person with memory complaints (anchored by -no SDM - complete SDM) and their self-efficacy regarding SDM (anchored by -not competent at all - very competent) after their last consultation with the patient.
Decisional conflict
时间窗: From the start of the 'before group phase' of the study studied up to 6 months. After implementation of the patient decision aid, the 'after group phase' will start and the measures will be studies up to 6 months after the start of this phase.
Decisional conflict of people with memory complaints and their significant others will be explored in a semi-structured interview (by telephone or face to face). The questions will focus on uncertainty regarding the choice made, factors contributing to this uncertainty, and perceived effectiveness of the decision.
次要结局
未报告次要终点