Impact of a Patient Decision Aid Intervention (IMPACTT)
Primary Purpose
Cancer, Breast, Cancer Colorectal
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pre-consultation electronic patient decision aid
In-consultation paper-based patient decision aid
Sponsored by
About this trial
This is an interventional health services research trial for Cancer, Breast focused on measuring Shared decision making, Patient decision aids, Patient preferences, Patient engagement
Eligibility Criteria
Inclusion Criteria:
- Histologically verified breast or colorectal cancer
- Age ≥ 18 years
Exclusion Criteria:
- Unable to read Danish
Sites / Locations
- Lillebaelt HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Arm A1: Breast cancer patients
Arm B1: Breast cancer patients
Arm A2: Colorectal cancer patients
Arm B2: Colorectal cancer patients
Arm Description
Outcomes
Primary Outcome Measures
Level of involvement of patients in shared decision making (breast cancer)
4-item Shared Decision Making Process Scale (SDM Process 4) with patient-reported measures of the amount of shared decision making that occurs around the medical decision. Score range is 0 to 4 points, a higher score indicates more involvement in the decision.
Observed level of patient involvement in decision making according to the OPTION5 tool (colorectal cancer)
settings (OPTION5). Scores range 0-100. Higher score indicates higher patient involvement in decision making.
Secondary Outcome Measures
Patient-perceived level of shared decision making (breast and colorectal cancer)
9-item Shared Decision Making Questionnaire (SDM-Q-9) that measures the extent to which patients are involved in the process of decision-making from the perspective of the patient. Scores range from 1 to 6 on each question. The total score range is thus 9-54 with 54 as the best score indicating higher involvement.
Patient-perceived level of shared decision making between patient and consultant (breast and colorectal cancer)
3-item questionnaire (CollaboRATE) with patient-reported measures of the perception of being informed and involved in decision making. Each item is scored on a 0 to 9 scale on a 10-point Likert scale, a higher score indicates a better experience.
Level of patient preparation for decision making (breast and colorectal cancer)
10-item questionnaire (Preparation for Decision Making Scale) with patient-reported measures of how useful the decision aid / decision support intervention is in preparing the patient for the consultation. The scale is from 1 (not at all useful) to 5 (very useful). Higher scores indicate greater preparation.
Level of decisional conflict (breast and colorectal cancer)
16-item questionnaire (Decisional conflict scale) with patient-reported measures of uncertainty and decisional conflict. Each item is rated on a 5-point scale, and total scores are calculated by summing the raw scores of all items and presenting them on a scale of 0-100, with higher scores indicating greater decision conflict. Scores greater than 25 indicate clinically important decisional conflict.
Degree of control over the decision about medical treatment (breast and colorectal cancer)
1-item questionnaire (Control Preference Scale) with a patient-reported measure of the degree of control that the patient wants to assume when decisions are being made about medical treatment. Answers range from Fully active role, Semiactive role, Collaborative role, Semipassive role and Fully passive role.
Consultant-perceived level of shared decision making (breast and colorectal cancer)
9-item Shared Decision Making Questionnaire (SDM-Q-doc) that measures the extent to which patients are involved in the process of decision-making from the perspective of the consultant. The items are scored from 0 to 5 on a six-point Likert scale ranging from "completely disagree" (0) to "completely agree" (5). A linear transformation of item score sum yields a transformed score (0-100), with higher values indicating more shared decision making.
Observed level of patient involvement in decision making according to the OPTION5 tool (breast cancer)
Measuring shared decision making by assessing recordings of encounters from clinical settings (OPTION5). Scores range 0-100. Higher score indicates higher patient involvement in decision making.
Level of involvement of patients in shared decision making (colorectal cancer)
4-item Shared Decision Making Process Scale (SDM Process 4) with patient-reported measures of the amount of shared decision making that occurs around the medical decision. Score range is 0 to 4 points, a higher score indicates more involvement in the decision.
Full Information
NCT ID
NCT05573022
First Posted
September 20, 2022
Last Updated
January 17, 2023
Sponsor
Vejle Hospital
Collaborators
The Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05573022
Brief Title
Impact of a Patient Decision Aid Intervention
Acronym
IMPACTT
Official Title
Impact of a Patient Decision Aid Intervention for Cancer Patients. Does Timing and Format Matter?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
Collaborators
The Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Studies evaluating decisions aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. However, timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing an electronic pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived levels as well as an observed level of shared decision making.
Detailed Description
A cancer diagnosis is life-changing and followed by complex decisions about treatment options. Often the decision about which treatment to choose is based on risks and benefits, although the benefit-harm ratios are unknown. In these situations, a patient decision aid can be helpful in explaining the options, clarifying the patient's preferences and acting as an adjunct to the clinician's counselling, supporting the patient in complex decisions about their diagnosis.
Studies evaluating patient decision aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. There is a lack of evidence of the impact of patient decison aids used pre-consultation versus in-consultation, as timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing a digital pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived level as well as an observed level of shared decision making (SDM).
A secondary analysis of the data collected in the study will form the basis of a study testing the convergent validity of the patient-reported measures by comparing them to the observed level of patient involvement. During the last decade, the strong move towards increased SDM has led to development of several measurement scales, and there is a demand for convergent validity studies, as there is no gold standard to evaluate SDM behaviors. Previous validity studies have various shortcomings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer Colorectal
Keywords
Shared decision making, Patient decision aids, Patient preferences, Patient engagement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is designed as a randomised, controlled trial, in which patients are allocated to either a digital pre-consultation patient decision aid or a paper-based in-consultation patient decision aid. A total estimate of 204 patients with breast and 70 patients with colorectal cancer are included in the study including 10% to compensate for missing data and dropouts.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A1: Breast cancer patients
Arm Type
Experimental
Arm Title
Arm B1: Breast cancer patients
Arm Type
Active Comparator
Arm Title
Arm A2: Colorectal cancer patients
Arm Type
Experimental
Arm Title
Arm B2: Colorectal cancer patients
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pre-consultation electronic patient decision aid
Intervention Description
This group is invited to access an electronic version before the consultation. The group of colorectal cancer patients is also introduced to a paper-based version by the clinician in the consultation.
Intervention Type
Other
Intervention Name(s)
In-consultation paper-based patient decision aid
Intervention Description
This group is introduced to a paper-based version by the clinician in the consultation
Primary Outcome Measure Information:
Title
Level of involvement of patients in shared decision making (breast cancer)
Description
4-item Shared Decision Making Process Scale (SDM Process 4) with patient-reported measures of the amount of shared decision making that occurs around the medical decision. Score range is 0 to 4 points, a higher score indicates more involvement in the decision.
Time Frame
Within one week after the consultation
Title
Observed level of patient involvement in decision making according to the OPTION5 tool (colorectal cancer)
Description
settings (OPTION5). Scores range 0-100. Higher score indicates higher patient involvement in decision making.
Time Frame
Through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Patient-perceived level of shared decision making (breast and colorectal cancer)
Description
9-item Shared Decision Making Questionnaire (SDM-Q-9) that measures the extent to which patients are involved in the process of decision-making from the perspective of the patient. Scores range from 1 to 6 on each question. The total score range is thus 9-54 with 54 as the best score indicating higher involvement.
Time Frame
Within one week after the consultation
Title
Patient-perceived level of shared decision making between patient and consultant (breast and colorectal cancer)
Description
3-item questionnaire (CollaboRATE) with patient-reported measures of the perception of being informed and involved in decision making. Each item is scored on a 0 to 9 scale on a 10-point Likert scale, a higher score indicates a better experience.
Time Frame
Within one week after the consultation
Title
Level of patient preparation for decision making (breast and colorectal cancer)
Description
10-item questionnaire (Preparation for Decision Making Scale) with patient-reported measures of how useful the decision aid / decision support intervention is in preparing the patient for the consultation. The scale is from 1 (not at all useful) to 5 (very useful). Higher scores indicate greater preparation.
Time Frame
Within one week after the consultation
Title
Level of decisional conflict (breast and colorectal cancer)
Description
16-item questionnaire (Decisional conflict scale) with patient-reported measures of uncertainty and decisional conflict. Each item is rated on a 5-point scale, and total scores are calculated by summing the raw scores of all items and presenting them on a scale of 0-100, with higher scores indicating greater decision conflict. Scores greater than 25 indicate clinically important decisional conflict.
Time Frame
Before consultation and within one week after the consultation
Title
Degree of control over the decision about medical treatment (breast and colorectal cancer)
Description
1-item questionnaire (Control Preference Scale) with a patient-reported measure of the degree of control that the patient wants to assume when decisions are being made about medical treatment. Answers range from Fully active role, Semiactive role, Collaborative role, Semipassive role and Fully passive role.
Time Frame
Before the consultation
Title
Consultant-perceived level of shared decision making (breast and colorectal cancer)
Description
9-item Shared Decision Making Questionnaire (SDM-Q-doc) that measures the extent to which patients are involved in the process of decision-making from the perspective of the consultant. The items are scored from 0 to 5 on a six-point Likert scale ranging from "completely disagree" (0) to "completely agree" (5). A linear transformation of item score sum yields a transformed score (0-100), with higher values indicating more shared decision making.
Time Frame
Within one week after the consultation
Title
Observed level of patient involvement in decision making according to the OPTION5 tool (breast cancer)
Description
Measuring shared decision making by assessing recordings of encounters from clinical settings (OPTION5). Scores range 0-100. Higher score indicates higher patient involvement in decision making.
Time Frame
Through study completion, an average of 3 months
Title
Level of involvement of patients in shared decision making (colorectal cancer)
Description
4-item Shared Decision Making Process Scale (SDM Process 4) with patient-reported measures of the amount of shared decision making that occurs around the medical decision. Score range is 0 to 4 points, a higher score indicates more involvement in the decision.
Time Frame
Within one week after the consultation
Other Pre-specified Outcome Measures:
Title
Consultation length measured in minutes
Description
Length of consultation in minutes
Time Frame
Through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically verified breast or colorectal cancer
Age ≥ 18 years
Exclusion Criteria:
Unable to read Danish
Not the owner/user of a mobile smartphone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bettina Mølri Knudsen
Phone
+4524994549
Email
bettina.knudsen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karina Dahl Steffensen
Organizational Affiliation
Sygehus Lillebaelt
Official's Role
Study Chair
Facility Information:
Facility Name
Lillebaelt Hospital
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bettina Mølri Knudsen
Phone
+4524994549
Email
bettina.knudsen@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plan to make data available to others
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Impact of a Patient Decision Aid Intervention
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