Impact of a Patient Decision Aid Intervention

Cancer, Breast Clinical Trial

— IMPACTT  

Official title:

Impact of a Patient Decision Aid Intervention for Cancer Patients. Does Timing and Format Matter?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573022
• Other study ID #: IMPACTT
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Vejle Hospital
• Contact: Bettina Mølri Knudsen
• Phone: +4524994549
• Email: bettina.knudsen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Colorectal
• Cancer, Breast

Intervention

Other:
• Pre-consultation electronic patient decision aid
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.
• In-consultation paper-based patient decision aid
This group is introduced to a paper-based version by the clinician in the consultation

Locations

Country	Name	City	State
Denmark	Lillebaelt Hospital	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Vejle Hospital	The Ottawa Hospital Research Institute

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Consultation length measured in minutes	Length of consultation in minutes	Through study completion, an average of 3 months
Primary	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.	Within one week after the consultation
Primary	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.	Through study completion, an average of 3 months
Secondary	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.	Within one week after the consultation
Secondary	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.	Within one week after the consultation
Secondary	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.	Within one week after the consultation
Secondary	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.	Before consultation and within one week after the consultation
Secondary	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.	Before the consultation
Secondary	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.	Within one week after the consultation
Secondary	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.	Through study completion, an average of 3 months
Secondary	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.	Within one week after the consultation