DementiaS-DeciDeDNCT04531956
Implementation of a Diagnostic Decision-aid for People With Memory Complaints and Their General Practitioners
A study testing Diagnostic decision aid s-decided in people with Dementia and Dementia Alzheimers, run by Maastricht University at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Dementia Alzheimers, Dementia, Mild
- What is being tested?
- Diagnostic decision aid s-decided
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2021to 20 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
The investigators therefore aim to include between 30 and 40 GPs in our study which seems to be a realistic number based on a previous (comparable) study.
For the qualitative component of the study, it is expected that interviews with 15-30 patients, with or without their significant other will be sufficient to reach data-saturation (i.e. the point at which interviews reveal no new information or insights). Participants will be asked to participate in an interview based on the outcome of the decision-making process (i.e. to wait and see, undergo diagnostic testing at the GP, be referred to a medical center for advanced diagnostic testing). In this way, the investigators can ensure that each 'choice-category' is represented in the selective sample. From those patients not selected for the interviews, only qualitative data from their medical journals (e.g. free text notes) will be analysed. This procedure will be the same in the before and after group. For the interviews with the GPs, it is anticipated that participation of 20-25% of the included GPs will be enough to reach data-saturation.
Data analysis Quantitative analysis Descriptive analyses will be conducted on the sociodemographic characteristics of people with memory complaints, their significant others, and GPs. To assess the decision-making process, descriptive analyses will be conducted on: number of consultations before final decision, final decision (i.e. number of decisions in each 'choice category'), level of SDM, and level of self-efficacy regarding SDM as indicated by GPs. Data will be reported as percentages, numeric counts, and means/standard deviations (SD). Furthermore, multiple regression analysis will be performed to investigate: (1) whether sociodemographic characteristics or characteristics of the decision-making process are related to the outcome of the decision-making process or to the level of SDM and (2) whether the level of SDM is associated with the outcome of the decision-making process. A random effect multilevel analysis will be used to assess changes in the decision-making process before and after implementing the SDM intervention while taking clustering at the GP level into account. Baseline characteristics will be added as confounders in case of observed differences in the before and after group. Integration of these analyses with qualitative measures will help explain these results. All analyses will be conducted using SPSS.
Qualitative analysis Qualitative methods will be used to analyse data regarding experiences in the decision-making process, SDM, and decisional conflict. Interviews will be audio-taped and transcribed verbatim. Two independent researchers will analyse the transcripts using content analysis. The same researchers will agree on codes, combine codes to create categories (axial coding), and combine categories and refine themes (selective coding). Atlas.ti will be used to support the analyses.
Mixed model analysis Integration of quantitative and qualitative research methods will be applied during data collection as well as during analyses. During data collection, attention will be paid to 'building' and 'merging'. Building will be applied by selecting patients for semi-structured interviews based on quantitative data such as age, gender, and the final decision outcome of the decision-making process. GPs will be selected based on their scores on the quantitative measures SDM-Q-Doc and the self-efficacy VAS as well as on the same criteria of age and gender. Merging will be applied through tailoring topic lists for the semi-structured interviews to the personal situation of patients and their significant others, a task which will be accomplished with the help of information from their medical record. During data analyses, 'merging' and 'embedding' will be applied (i.e. qualitative data will be used to explain identified patterns in quantitative outcome measures which will provide insight into the working mechanisms of the SDM intervention).
Ethics and Dissemination Care as usual will most likely not be influenced in the before group of the S-DeciDeD project. Only a small-time investment will be required from GPs and patients: 5 minutes for completing the questionnaires and twenty minutes for participating in the interview. The protocol of the before group has been approved by the Medical Review Ethics Committee (MEC) of the Maastricht University Medical Centre (MUMC+) in the Netherlands, number 2018-0333. Data collection in the before group will start in the beginning of 2021.
The protocol for the after group will be submitted to the MEC after the development of the patient decision aid as judgement should include full information on this novel intervention. The S-DeciDeD project is part of the national Memorabel programme funded by ZonMw.
Furthermore, as Maastricht University aims to become a FAIR (Findable, Accessible, Interoperable and Re-usable) university, the data will also be published on DataverseNL (https://dataverse.nl/). This is a website where researchers can upload their anonymous data with restricted access, which allows other researchers to use the data or replicate the findings after receiving permission from the S-DeciDeD project. Finally, the findings will be published in peer-reviewed international journals and presented at conferences and in one dissertation.
- Conditions
- Dementia, Dementia Alzheimers, Dementia, Mild
- Being tested
- Diagnostic decision aid s-decided
- Keywords
- Dementia, memory complaints, timely diagnosis, shared decision-making, decision aid, general practice
- Medical subject headings
- Dementia, Alzheimer Disease, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic decision aid s-decidedOther
The intervention will consist of implementing a patient decision aid (PtDA) in general practice. The patient decision aid will be developed in line with the systematic development process specified by the International Patient Decision Aids Standards (IPDAS)
| Study group | Role | What they receive |
|---|---|---|
| Before group | No intervention | In the before group (BG) GPs will execute care as usual in the decision-making process for a diagnostic trajectory for memory complaints. |
| After group | Active comparator | In the after group (AG), a patient decision aid will be added to the decision-making process provided by the GP. Receives: Other: Diagnostic decision aid s-decided |
What is being measured
The primary outcome is the main question the study is designed to answer.
The course of the decision-making process (number of consultations)
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.
Measured: 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.
Final outcome of the decision-making process
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.
Measured: 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.
Experiences during the decision-making process (people with memory complaints)
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.
Measured: 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.
Experiences during the decision-making process (significant others of people with memory complaints)
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.
Measured: 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.
Experiences during the decision-making process (general practitioners)
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.
Measured: 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.
Perceived shared decision-making
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
Measured: 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 shared decision-making
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.
Measured: 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 shared decision making
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.
Measured: 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
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.
Measured: 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 (free text notes)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Jan 2021
- Primary completion20 Oct 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a before-after 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Rudolf Ponds, Professor, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531956
- Sponsor's protocol ID
- 70-73305-98-1225
- Acronym
- S-DeciDeD
- Status last verified
- Jan 2024
- First submitted
- 30 Jul 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As Maastricht University aims to become a FAIR (Findable, Accessible, Interoperable and Re-usable) university, the data will be published on DataverseNL (https://dataverse.nl/). This is a website where researchers can upload their anonymous data with restricted access, which allows other researchers to use the data or replicate the findings after receiving permission from the S-DeciDeD project.
Publications
Linden I, Wolfs C, Perry M, Metsemakers J, van der Weijden T, de Vugt M, Verhey FR, Handels R, Olde Rikkert M, Dirksen C, Ponds RWHM. Implementation of a diagnostic decision aid for people with memory complaints and their general practitioners: a protocol of a before and after pilot trial. BMJ Open. 2021 Jun 16;11(6):e049322. doi: 10.1136/bmjopen-2021-049322.
PubMed 34135053
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04531956
- Acronym / sponsor ID
- S-DeciDeD / 70-73305-98-1225
- Conditions
- Dementia, Dementia Alzheimers, Dementia, Mild
- Keywords
- Dementia, memory complaints, timely diagnosis, shared decision-making, decision aid, general practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators therefore aim to include between 30 and 40 GPs in our study which seems to be a realistic number based on a previous (comparable) study.
For the qualitative component of the study, it is expected that interviews with 15-30 patients, with or without their significant other will be sufficient to reach data-saturation (i.e. the point at which interviews reveal no new information or insights). Participants will be asked to participate in an interview based on the outcome of the decision-making process (i.e. to wait and see, undergo diagnostic testing at the GP, be referred to a medical center for advanced diagnostic testing). In this way, the investigators can ensure that each 'choice-category' is represented in the selective sample. From those patients not selected for the interviews, only qualitative data from their medical journals (e.g. free text notes) will be analysed. This procedure will be the same in the before and after group. For the interviews with the GPs, it is anticipated that participation of 20-25% of the included GPs will be enough to reach data-saturation.
Data analysis Quantitative analysis Descriptive analyses will be conducted on the sociodemographic characteristics of people with memory complaints, their significant others, and GPs. To assess the decision-making process, descriptive analyses will be conducted on: number of consultations before final decision, final decision (i.e. number of decisions in each 'choice category'), level of SDM, and level of self-efficacy regarding SDM as indicated by GPs. Data will be reported as percentages, numeric counts, and means/standard deviations (SD). Furthermore, multiple regression analysis will be performed to investigate: (1) whether sociodemographic characteristics or characteristics of the decision-making process are related to the outcome of the decision-making process or to the level of SDM and (2) whether the level of SDM is associated with the outcome of the decision-making process. A random effect multilevel analysis will be used to assess changes in the decision-making process before and after implementing the SDM intervention while taking clustering at the GP level into account. Baseline characteristics will be added as confounders in case of observed differences in the before and after group. Integration of these analyses with qualitative measures will help explain these results. All analyses will be conducted using SPSS.
Qualitative analysis Qualitative methods will be used to analyse data regarding experiences in the decision-making process, SDM, and decisional conflict. Interviews will be audio-taped and transcribed verbatim. Two independent researchers will analyse the transcripts using content analysis. The same researchers will agree on codes, combine codes to create categories (axial coding), and combine categories and refine themes (selective coding). Atlas.ti will be used to support the analyses.
Mixed model analysis Integration of quantitative and qualitative research methods will be applied during data collection as well as during analyses. During data collection, attention will be paid to 'building' and 'merging'. Building will be applied by selecting patients for semi-structured interviews based on quantitative data such as age, gender, and the final decision outcome of the decision-making process. GPs will be selected based on their scores on the quantitative measures SDM-Q-Doc and the self-efficacy VAS as well as on the same criteria of age and gender. Merging will be applied through tailoring topic lists for the semi-structured interviews to the personal situation of patients and their significant others, a task which will be accomplished with the help of information from their medical record. During data analyses, 'merging' and 'embedding' will be applied (i.e. qualitative data will be used to explain identified patterns in quantitative outcome measures which will provide insight into the working mechanisms of the SDM intervention).
Ethics and Dissemination Care as usual will most likely not be influenced in the before group of the S-DeciDeD project. Only a small-time investment will be required from GPs and patients: 5 minutes for completing the questionnaires and twenty minutes for participating in the interview. The protocol of the before group has been approved by the Medical Review Ethics Committee (MEC) of the Maastricht University Medical Centre (MUMC+) in the Netherlands, number 2018-0333. Data collection in the before group will start in the beginning of 2021.
The protocol for the after group will be submitted to the MEC after the development of the patient decision aid as judgement should include full information on this novel intervention. The S-DeciDeD project is part of the national Memorabel programme funded by ZonMw.
Furthermore, as Maastricht University aims to become a FAIR (Findable, Accessible, Interoperable and Re-usable) university, the data will also be published on DataverseNL (https://dataverse.nl/). This is a website where researchers can upload their anonymous data with restricted access, which allows other researchers to use the data or replicate the findings after receiving permission from the S-DeciDeD project. Finally, the findings will be published in peer-reviewed international journals and presented at conferences and in one dissertation.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a before-after 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.
| Arm | Type | Receives |
|---|---|---|
| Before group | No intervention | –In the before group (BG) GPs will execute care as usual in the decision-making process for a diagnostic trajectory for memory complaints. |
| After group | Active comparator | Other: Diagnostic decision aid s-decidedIn the after group (AG), a patient decision aid will be added to the decision-making process provided by the GP. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic decision aid s-decidedThe intervention will consist of implementing a patient decision aid (PtDA) in general practice. The patient decision aid will be developed in line with the systematic development process specified by the International Patient Decision Aids Standards (IPDAS) | Other | After group |
Primary outcome
The course of the decision-making process (number of consultations)
Time frame: 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.
Final outcome of the decision-making process
Time frame: 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 (people with memory complaints)
Time frame: 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.
Experiences during the decision-making process (significant others of people with memory complaints)
Time frame: 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.
Experiences during the decision-making process (general practitioners)
Time frame: 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.
Perceived shared decision-making
Time frame: 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
Level of shared decision-making
Time frame: 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
Time frame: 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
Time frame: 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.
The course of the decision-making process (free text notes)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 34135053Linden I, Wolfs C, Perry M, Metsemakers J, van der Weijden T, de Vugt M, Verhey FR, Handels R, Olde Rikkert M, Dirksen C, Ponds RWHM. Implementation of a diagnostic decision aid for people with memory complaints and their general practitioners: a protocol of a before and after pilot trial. BMJ Open. 2021 Jun 16;11(6):e049322. doi: 10.1136/bmjopen-2021-049322.
- Individual participant dataSharing planned: Yes. As Maastricht University aims to become a FAIR (Findable, Accessible, Interoperable and Re-usable) university, the data will be published on DataverseNL (https://dataverse.nl/). This is a website where researchers can upload their anonymous data with restricted access, which allows other researchers to use the data or replicate the findings after receiving permission from the S-DeciDeD project.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf Ponds, Professor principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic decision aid s-decided in people with Dementia and Dementia Alzheimers, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The course of the decision-making process (number of consultations) (time frame: 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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.