UMIN-CTR Clinical Trial

Public title

Do checklist-induced behavioral changes improve self-confidence in fundoscopy?

Acronym

Do checklist-induced behavioral changes improve self-confidence in fundoscopy?

Scientific Title

Do checklist-induced behavioral changes improve self-confidence in fundoscopy?

Scientific Title:Acronym

Do checklist-induced behavioral changes improve self-confidence in fundoscopy?

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Fundoscopy is not often performed because of lack of confidence in the procedure due to insufficient experience. We hypothesized the introduction of a checklist for fundoscopy may motivate physicians to perform fundoscopy, resulting in the accumulation of experiences which would lead to building their confidence.

Basic objectives2

Others

Basic objectives -Others

educational effect

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The implementation ratio of fundoscopy was analyzed employing the chi-square test; the Visual Analog Scale (VAS) value for confidence, the corresponding t test; psychological factors extracted from the interview, the modified grounded theory approach.

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

A checklist was introduced to confirm that fundoscopy was performed during the intervention period.

Interventions/Control_2

A checklist was not introduced.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

24

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The participants were 13 general medicine physicians in charge of first visit outpatients.

Key exclusion criteria

Among them, those who were unable to obtain consent and those who never took the first visit were excluded from the participants.

Target sample size

13

Name of lead principal investigator

1st name	Daiki
Middle name
Last name	Yokokawa

Organization

Chiba University Hospital

Division name

Department of General Medicine

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref., Japan

TEL

043-222-7171

Email

dyokokawa6@gmail.com

Name of contact person

1st name	Daiki
Middle name
Last name	Yokokawa

Organization

Chiba University Hospital

Division name

Department of General Medicine

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref., Japan

TEL

043-222-7171

Homepage URL

Email

dyokokawa6@gmail.com

Institute

Chiba University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba University Hospital

Address

1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref., Japan

Tel

043-222-7171

Email

043-222-7171

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

05

Month

31

Day

URL releasing protocol

https://www.dovepress.com/do-checklist-induced-behavioral-changes-improve-self-confidence-in-fun-pee

Publication of results

Unpublished

URL related to results and publications

https://www.dovepress.com/do-checklist-induced-behavioral-changes-improve-self-confidence-in-fun-pee

Number of participants that the trial has enrolled

15

Results

We observed significant increases in the implementation ratio (19.2% (29/151 cases) vs 64.8% (105/162 cases), p< 0.001) and in the VAS value for the confidence (1.89 mm vs 4.68 mm (p< 0.001)). To increase the implementation, it is necessary to reduce the <Lack of confidence> and <Forgetting>, which is prevented by the checklist. The <Lack of successful experiences in detecting abnormalities> leads to a <Lack of confidence>. Repeated executions result in <Successful experiences and confidence building>.

Results date posted

2022

Year

05

Month

17

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

11

Month

23

Day

Baseline Characteristics

The subjects of this study satisfy two conditions. The first condition was that they are physicians who can independently conduct fundoscopic exams and gain confidence in the procedure. The second condition was that the subjects were novice medical practitioners (they had graduated less than 10 years prior) who had completed their first 2 years of medical residency. The subjects were selected so that the study could track them as their experience with fundoscopic exams increased. We needed to exclude subjects with high confidence or experience.

In line with these conditions, we uniformly sampled 15 doctors, who were beginners in fundoscopy, assigned to initial outpatient consultations at the Department of General Medicine at Chiba University Hospital. They were not residents, but fellows in this department. We excluded physicians who did not undertake any initial consultations during the research period, who did not conduct medical examinations of patients indicated for the fundoscopic exam, and who were partially absent due to training in other hospitals. For physicians who met the conditions more than once across multiple time periods, we only sampled the first record and excluded all subsequent ones.

Participant flow

Phase 1 (target period) spans April to May 2016, April to May 2017, and October to November 2017. Phase 2 (intervention period) spans the two months following each target period. Phase 3 (post-intervention period) was set as August to September 2016 only. The three varying periods were set because the physician assigned to the initial outpatient consultation changed over time. In Phase 1, we measured the implementation rates for fundoscopic exams without interventions. In Phase 2, we carried out an intervention as described below. At the end of Phase 1 and Phase 2, we administered a self-completed questionnaire and semi-structured interview. Introductory teaching sessions, including hands-on training in ophthalmoscopy, were provided before Phase 1.

The intervention is the introduction of a checklist that verifies whether the fundoscopic exam was implemented, included a structured multiple-choice question addressing possible reasons why the exam was not implemented (multiple answers were allowed). Principal investigator (PI) (DY) and the research collaborator (KS) prepared and test the checklist . The checklist was printed and presented at the start of the consultation. Participants completed the checklist immediately following the medical consultation. They were required to discuss all cases with the attending physician. They can complete the checklist within one minute. The attending physician signed the checklist during consultation in order to avoid any omissions by participants. The attending physician did not make any recommendations to participants about whether to perform fundoscopy or not. Participants have the opportunity to receive feedback on fundoscopic findings during outpatient consulting, and in regular practice, they almost always receive it from the attending physicians. Participants could refer patients to the department of ophthalmology in the same hospital for close examination of fundus abnormalities. They submitted the checklist at the end of the consultation to a designated box. PI collected a checklist from that box periodically and tabulated them.

Adverse events

No adverse events were identified.

Outcome measures

Of the quantitative data, a chi-2 test was used on the implementation ratio, ratio of indication cases, and the responses of the self-completed questionnaires conducted at the end of Phases 1 and 2. We used Fisher's exact test when more than 20% of the expected values were less than 5. We quantified the VAS values in a range of [0-10.0] and analyzed them using the paired t-test. Statistical analyses were performed using SPSS Statistics for Windows 22.0 (IBM Corp. Armonk, NY).

To analyze the qualitative data, we used the Modified Grounded Theory Approach (M-GTA). We assumed that the implementation of the fundoscopic exam by a novice medical practitioner possesses reciprocity such as physician factors, exam characteristics, patient factors, and the healthcare system. We also assumed that the attainment of confidence is procedural; thus, we used M-GTA as the methodology to perform the analysis.

Based on the M-GTA analysis, we set the focus of analysis to be novice medical practitioners implementing the fundoscopic exam, and the theme of analysis to be the reasons for implementation or non-implementation of the fundoscopic exam, as well as the psychological processes behind the attainment of confidence. We highlighted the focus of analysis themes in the verbatim interview, identified relevant parts, recorded them as specific examples, and attempted to create concepts that resembled these examples. An analysis worksheet was used to generate the concepts; we then entered the names, definitions, specific examples, and theoretical memos of the concepts. Similarly, we proceeded with the analysis of the sentences, each time generating a new concept to create an analysis sheet. With the generated concepts, we verified similar examples between the concepts and compared the opposite examples. We entered such relationships between concepts into the theoretical memo to prevent the list of concepts from becoming arbitrarily biased. We created categories based on these inter-conceptual relationships, highlighted the analysis themes, and examined whether they could explain the entire process.

We conducted a pre-intervention interview and analyses, then conducted a post-intervention interview and added an analysis in each subsequent period. After verifying that the data across 15 participants (30 interviews) possessed no excess or deficiencies in interpretation, we determined theoretical saturation and created categories, story lines, and result diagrams.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

04

Month

01

Day

Date of IRB

2017

Year

05

Month

29

Day

Anticipated trial start date

2017

Year

04

Month

01

Day

Last follow-up date

2018

Year

03

Month

31

Day

Date of closure to data entry

2018

Year

03

Month

31

Day

Date trial data considered complete

2018

Year

07

Month

31

Day

Date analysis concluded

2019

Year

03

Month

31

Day

Other related information

Registered date

2018

Year

05

Month

25

Day

Last modified on

2022

Year

05

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037305