Condition category
Surgery
Date applied
30/12/2019
Date assigned
08/01/2020
Last edited
07/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Knee and hip replacement surgery involves replacing worn bones and cartilage with artificial materials. There is a wide range of cost associated with these materials, but also issues of safety and side effects to consider. Patients and surgeons should both be involved in selecting the most appropriate surgical procedure and materials used. This study aims to investigate a program that helps doctors and patients make informed and cost-effective decisions.

Who can participate?
The study recruits both orthopedic (joint) specialists and adult patients who are waiting for hip or knee joint replacement surgery

What does the study involve?
Hospitals will be randomly allocated into one of two groups. Patients and doctors in the intervention arm will receive 18 months' access to an independent consultation and feedback intervention program designed by the study on the basis of routine medical services. Hospitals in the control group will continue as usual.

What are the possible benefits and risks of participating?
For patients, the benefits of participation may include reduced medical costs, more complete and accurate clinical history recording and more reasonable and transparent clinical decision-making and better health outcomes. For patients, the risks of participation may include increased risk of privacy exposure and more psychological pressure in communicating with doctors.
For doctors, the benefits of participation may include better doctor-patient relationships, reduced deficiencies and moral hazards in decision-making, improved patient trust of patients and better standardization of medical practices.The study risks for doctors may include increased workload and longer time spent in clinical decision-making.

Where is the study run from?
The First Affiliated Hospital of University of Science and Technology of China

When is the study starting and how long is it expected to run for?
June 2018 to June 2023

Who is funding the study?
Key Research and Development Projects of Anhui (China ) and the Fundamental Research Funds for the Central Universities (China)

Who is the main contact?
Mr Guixian Tong, gxtong@fsyy.ustc.edu.cn

Trial website

Contact information

Type

Scientific

Primary contact

Mr Guixian Tong

ORCID ID

Contact details

No.17 Lujiang Road
Hefei
230001
China
+86 (0)55162283037
gxtong@fsyy.ustc.edu.cn

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Smartphone and web-based independent consultation and feedback for joint replacement surgeries: a randomized controlled trial

Acronym

ICFS

Study hypothesis

Independent consultation and feedback system (ICFS) can optimize clinical decisions on use of medical materials for patients needing joint replacement surgery

Ethics approval

Approved 05/03/2019, Biomedical Ethics Committee of the University of Science and Technology of China (17 Lujiang Road, Hefei, Anhui, China; +86-(0)551-62282931; ahslyyllwyh@163.com), ref: 2019-N(H)-213

Study design

Cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available.

Condition

Hip or knee joint replacement surgery

Intervention

The study utilizes a quasi-RCT design involving patients needing joint replacement surgery and the corresponding orthopedic surgeons selected, from hospitals of Anhui province, randomized into equal intervention and control arms. The intervention arm receives 18 months' access to an independent consultation and feedback intervention program designed by the study on the basis of the routine medical services; while the control arm receives routine medical services.

The intervention consists of two main components targeting patients and doctors.
For patients, the intervention has four parts:
1. PI1 (option assessment). PI1 contains a cost-benefit evaluation aid. The objectives of PI1 is to help patients make a relatively systematic evaluation of the alternative diagnosis and treatment procedures, including medical materials (MMs) use. The intervention contents of PI1 include materials to:
1.1. Display to patient diagnosis/treatment alternatives (especially options of MM use) and corresponding advantages, disadvantages and indications
1.2. Provide problem-solving cases so as to eliminate the problems and doubts that patients may have regarding their current conditions and MMs use
1.3. Provide structured cost-utility rating scale to help patients systematically evaluate different joint replacement procedures/MMs on their physiological, psychological and social functions
1.4. Provide easy-to-understand cost-utility evaluation summaries to help comparison and selection of different treatment/MM options
2. PI2 (facts review and confirmation). The intervention contents of PI2 include materials to:
2.1. Remind the patient of the importance of reporting and recording accurate symptoms and medical history
2.2. Provide a relatively 'private' and 'independent' environment for patients to check and supplement information on their symptoms and medical history without being affected by relatives, friends, doctors, etc.
2.3. Ask patient to perform at least twice a 'facts review and confirmation', once before treatment and MMs use and another 1 week after discharge from hospital
3. PI3 (self-expression). The intervention contents of PI3 include materials to:
3.1. Tell patients which views about doctors/hospitals are misunderstood
3.2. Tell patients to fully and accurately tell doctors about their condition, especially the experiences that doctors can not detect or feel
3.3. Tell patients that they can ask doctors to provide a private environment for discussing their illness
3.4. Tell patients that they can be confident in correcting their symptoms and medical history over time
3.5. Tell patients that they need to straightforwardly speak about their diagnosis, treatment decisions, expectations and difficulties
4. PI4 (Follow-up promotion/aid). The intervention contents of PI4 include materials to:
4.1. Deliver text messages to patient participants every day to mobilize and guide them to taking medicine according doctor's advice, carrying out rehabilitation training, and improving behavior and habits, etc.
4.2. Follow up patients’ satisfaction and trust in the doctors and hospitals, the occurrence and severity of complications after MMs use, the degree of recovery of related organ functions, related health behaviors (e.g., physical exercise, smoking and drinking), related quality of life (data collected via EQ-5D-3L scale), etc.

For doctors, the intervention also has four parts:
5. DI1 (Evidence/guideline reminding). The intervention contents of DI1 include materials to:
5.1. Periodically provide literature reviews and the latest reported RCT findings to the doctors
5.2. Remind doctors of the related regulatory norms and guidelines issued by competent authorities and authoritative academic organizations
6. DI2 (Need/preference presentation). The intervention contents of DI2 include materials to:
6.1. Deliver to doctors patients’ scores and rankings of various alternative treatment schedules and joint replacement related MMs
6.2. Present to doctors the effectiveness evaluation results on the main related physiological functions, complications, quality of life, etc. at different time points after leaving hospital
6.3. Collect patients’ attitudes and satisfaction with joint replacement surgery services
7. DI3 (Diagnosis/treatment audit). The intervention contents of DI3 include materials to:
7.1. Organize authoritative experts to formulate a working 'standardized evaluation index system of joint replacement surgery decisions and MMs use', and deliver the medical records of patients who have undergone joint replacement to the expert group for independent scoring
7.2. Compare doctors’ diagnosis and treatment activities to clinical pathways and present the gaps between them
8. DI4 (Performance feedback). The intervention contents of DI4 include materials to:
8.1. Make comparisons of follow-up results (including functional recovery, complications, quality of life, satisfaction, etc.) among different clinical schedules at different time points after leaving hospital
8.2. Periodically (monthly and quarterly) compare the use rate of different types of implant joint MMs and the subsequent patient function-related indicators among doctors
8.3. Perform 'confirmations' twice to compare patient responses with the medical records recorded by doctors

Each of these intervention ingredients is designed to tackle the doctor- and patient-side problems with existing medical materials.

The patients access and interact with the program via a smartphone-based app and the doctors use a web-based clinical support system (CSS).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Quality-of-life assessed using the EQ-5D-5L scale at 6 months, 12 months and 18 months after discharge
2. Cost of medical materials assessed using questionnaire custom-designed for this study at 6 months after discharge

These data will be used to calculated cost-effectiveness.

Secondary outcome measures

1. Peer expert audit score assessed using a custom-designed questionnaire at 6 months after discharge
2. Quality control inspection score assessed using a custom-designed questionnaire at 6 months after discharge
3. Patient awareness rate (treatment schedule, surgical risk, material selection, etc) assessed using a custom-designed questionnaire at discharge, and 6 months, 12 months and 18 months after discharge
4. Patient satisfaction assessed using a custom-designed questionnaire at discharge and 6 months after discharge
5. Total medical expense assessed using a custom-designed questionnaire at 6 months after discharge

Overall trial start date

01/06/2018

Overall trial end date

30/06/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Surgeons:
1. All orthopedic surgeons from the selected hospitals are encouraged to participate in this study

Patients:
1. Awaiting hip or knee joint replacement surgery
2. Have the ability to communicate and make independent decisions
3. Aged 18 years or older

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

1000 patients

Participant exclusion criteria

1. Patients unwilling to participate in the study
2. Patients with previous experience of hip or knee joint replacement surgeries
3. Patients unable to communicate clearly and/or make independent decisions

Recruitment start date

31/12/2020

Recruitment end date

31/12/2021

Locations

Countries of recruitment

China

Trial participating centre

The First Affiliated Hospital of University of Science and Technology of China
Hefei
230001
China

Sponsor information

Organisation

The First Affiliated Hospital of University of Science and Technology of China

Sponsor details

17 Lujiang Road
Hefei
230001
China
+86-(0)551-62283292
ahslyykyc@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Key Research and Development Projects of Anhui Province

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fundamental Research Funds for the Central Universities

Alternative name(s)

Fundamental Research Funds for the Central Universities of China, Fundamental Research Fund for the Central Universities

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

China

Results and Publications

Publication and dissemination plan

Planned publication in peer-reviewed scientific journals.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/01/2020: Trial's existence confirmed by the Biomedical Ethics Committee of the University of Science and Technology of China.