NCT04531956

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

July 30, 2020

Last Update Submit

January 22, 2024

Conditions

DementiaDementia AlzheimersDementia, Mild

Keywords

Dementiamemory complaintstimely diagnosisshared decision-makingdecision aidgeneral practice

Outcome Measures

Primary Outcomes (10)

  • 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.

    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.

    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.

    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.

    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.

    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

    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.

    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.

    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.

    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.

    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.

Other Outcomes (2)

  • Demographic data of people with memory complaints and their significant others

    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.

  • Characteristics general practitioner (GP)

    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.

Study Arms (2)

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.

Other: Diagnostic decision aid s-decided

Interventions

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)

After group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 ER, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34135053DERIVED

MeSH Terms

Conditions

DementiaAlzheimer DiseaseLymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Rudolf Ponds, Professor

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 31, 2020

Study Start

January 1, 2021

Primary Completion

October 20, 2022

Study Completion

November 20, 2022

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Locations

NL(1)