This study investigated whether providing a document template for patients to describe their values and preferences to their physician improves shared decision making when deciding to start a new medication. The study found that the template did not significantly reduce decision conflict or regret, but did increase agreement between the physician's recommendation and the patient's final decision. It also increased the rate of patients carefully considering the physician's opinion rather than immediately agreeing or refusing. The template may enhance dialogue and encourage patients to consider their physician's professional advice.

1. Does Giving the Doctor a Document
Template with the Patient's Own
Values and Preferences When
Making Decisions about Starting
Medication Improves Shared
Decision Making?
Seiji Bito, MD, MSHS 1 , Tomomi Iioka, MS 1 and
Atsushi Asai, MD, PhD, MBioeth 2 , (1)NHO Tokyo
Medical Center, Toyko, Japan, (2)Tohoku University,
Sendai, Japan
bitoseiji@gmail.com bitoseiji@
This presentation has no potential conflicts of interest

2. Background and Purpose
• Although there are several decision-support tools for
empowering patients at Shared Decision Making (SDM),
their effectiveness is limited.
• We have developed a document template for patients to
describe their own values and preferences, etc., in the
context of making a decision with their physician to start
drug medication.
• We investigated if any conflict in the decision process, the
decision making and the patient’s own decision could be
influenced by giving a written document with patient’s
preferences and values to her/his physician.

3. Professional explanation and
recommendation
understanding
Circumstances and preferences as a partyUnderstanding
The ideal theory that leads to Shared Decision Making
REPEAT
Agree on decision
making for the
patient’s best interest

4. Actual exchange
I can't say many
things about
myself …
“I AGREE” or
“I don’t want it”
Decision making far from patient’s best interest
Professional explanation and
recommendation
Understanding ?

5. Intervention and outcomes in the study
Decision Making
Agreement between professional recommendation and
final decision, Decision conflict, Decision Regret
Professional explanation and
recommendation
Understanding ?

6. Design: Multi-center Pre-post Study
Inclusion: Patients who are going to start new
antihypertensive, antihyperlipid or diabetes agents.
Eight medical centers participated
Control period. 6 moths
85 control group patients participated
Intervention period. 6 months
67 intervention group patients participated
ordinary decision
making pattern

7. Target Population
• Patients who were in a situation where their physicians
were considering the commencement of any new
antihypertensive, antihyperlipid or diabetes agents.

8. Intervention: Contents of the Template
• Patient’s worry
• Expectation of outcomes
• Expectation of the efficacy of the
medicine
• Self-care plan
• Things want to be avoided

9. Measures
• Independent variable
• Patient Characters
• Gender
• Living alone or not
• Comorbidity (Diabetes, Hypertension, Hyperlipidemia)
• Physician characters
• Health Locus of control
• Decision conflict

10. Measures
• Outcome
• Decision conflict and Decision Regret 2 months after decision.
• Decision Conflict Scale (0-100)
• Decision Regret Scale (0-100)
• Decision Status
• Percentage of those who started the drug, those who did not start, and
those who delayed their decision to start
• Percentage of agreement between physicians' recommended choices for
drug initiation and actual decision making
• Communication with his/her physician
• Understanding worries
• Enough communication
• Understanding what to do

11. Result. Diagram
Phase 1. 88 Control group included Phase 2. 87 Intervention group included
23 not respond at baseline
data collection
79 Control group followed 73 Intervention group followed
34 not respond at 2 month
follow up data
79 chart data and 67 questionnaire 73 chart data and 51 questionnaire

12. Result. Patient Characteristics and
baseline variables
Variable Control Group
(N=79)
Intervention Group
(N=73)
Woman (%) 57 55
Living alone (%) 16 16
Consultation with a companion (%) 13 12
Comorbidity
Diabetes (%)
Hypertension (%)
Hyperlipidemia (%)
15
42
52
11
52
45
Baseline Locus of Control Scale (0-100 score)
Internal
Chance*
Professional mean±SD
72±11
34±15
62±14
73±12
40±17
66±16
Baseline Decision Conflict Scale (0-100 score)
mean±SD
64±12 61±17
* p<0.05

13. Result. Decision conflict and
Decision Regret 2 months after
starting observation.
Control Intervention P value
Decision
Conflict Scale
(0-100 Mean±SD)
(N=65)
35.3 ± 12.2
(N=46)
38.9 ± 17.1 0.19
Decision
Regret Scale
(0-100 Mean±SD)
(N=66)
21.8 ± 12.6
(N=51)
22.0 ± 14.5 0.96

14. Result. Decision Status 3 months after
starting observation
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Intervention
Control
Decided Starting Drugs
Decided NOT Starting Drugs
Still Considering
P=0.015

15. Result. Percentage of agreement
between physicians' recommended
choices for drug initiation and
actual decision making
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Intervention
Control
Agree Disagree
75%
89% P=0.022

16. Discussion
• Templates were not significantly associated with Decision
Conflict or Decision Regret after the decision agenda was
introduced. Communicating patient’s preferences and
situations to his/her physician does not affect the conflicts and
regrets of the decisions made.
• Templates may have promoted awareness of interactive
context. With understanding beyond yes-no answer, the
patient may eventually choose a medically recommended
option.
• Physicians who read the template may have made adherence
and professional recommendations for patient preferences.

17. CONCLUSION
SUBMITTING WRITTEN DOCUMENTS
WITH PATIENT'S VALUES TO HIS/HER
PHYSICIAN IN ADVANCE OF A CLINICAL
DECISION MAKING MAY ENHANCE THE
DIALOGUE PROCESS ON SDM AND MAY
ENCOURAGE THE PATIENT TO
CAREFULLY LISTEN TO HIS/HER
PHYSICIAN’S PROFESSIONAL OPINION.

18. Abstract
• Purpose: Although there are several decision-support tools for empowering patients at Shared Decision Making
(SDM), their effectiveness is limited. We have developed a document template for patients to describe their own
values and preferences, etc., in the context of making a decision with their physician to start drug medication. We
investigated if any conflict in the decision process, the decision making and the patient’s own decision could be
influenced by giving a written document with patient’s preferences and values to her/his physician.
• Method: We examined a comparative study before and after setting a control period and an intervention period.
Study targets were patients who were in a situation where their physicians were considering the commencement
of any new antihypertensive, antihyperlipid or diabetes agents. For study intervention, there was a single-sheet
template that provided spaces to describe the following; patient’s worry; expectation of outcomes; expectation of
the efficacy of the medicine; self-care plan; things want to be avoid. The documented template was attached to
the electronic medical record so that the patient's physician could read it before the next consultation. A chart
review of the medical record after 3 months of registration examined the content of the actual decision and the
degree of agreement between the doctor's recommended option at the patient registration and the decision
actually made. We also compared the mean values of the Decision Conflict Scale (DCS) and the Decision Regret
Scale (DRS) two months after the study registration.
• Result: Seventy-nine controls and 73 intervention groups participated in the study. The mean value of the DCS in
the control and intervention groups was 35.3 ± 12.2, 38.9 ± 17.1 (p = 0.19) and 21.8 ± 12.6, 22.0 ± 14.5 (p =
0.96) for the DRS. Three months after registration, the percentage of those who started the drug, those who did
not start, and those who delayed their decision to start in the control group were 39%, 49%, and 11%, respectively.
While in the intervention group, it was 47%, 28%, and 24%, respectively (p = 0.015). Seventy-five percent of
controls and 89% of the intervention group were in agreement with the recommendations that their physicians
had in mind regarding the decision to take medications at the time of the patient’s registration.
• Conclusion: Submitting written documents with patient's values to his/her physician in advance of a clinical
decision making may enhance the dialogue process on SDM and may encourage the patient to carefully listen to
his/her physician’s professional opinion.