Thrombolytic TherapyNCT03317639
Improving In-hospital Stroke Service Utilisation in China
A study testing Behaviour Change Wheel model guided intervention in people with Thrombolytic Therapy and Acute Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombolytic Therapy, Acute Stroke, Door to Treatment Time
- What is being tested?
- Behaviour Change Wheel model guided intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,634 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AIS patients receiving IVT within 4.5 hours
Who cannot join
- Patients who are not willing to attend this trial
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
A cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. The randomisation will be conducted after one-year baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. Hospitals with no stroke centre or with <20 cases received thrombolysis per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage (post-intervention).
- Being tested
- Behaviour Change Wheel model guided intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour Change Wheel model guided interventionBehavioural
Interventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study.
| Study group | Role | What they receive |
|---|---|---|
| an intervention arm | Experimental | Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model Receives: Behavioral: Behaviour Change Wheel model guided intervention |
| a control arm | No intervention | hospitals in the control arm will receive no intervention and maintain existing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the percentage of patients who Door-to-Needle Time≤60min
Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage
Measured: Up to 24 hours
Secondary outcomes (6)
Door-to-needle time
The time between hospital arrival and the initiation of IVT
Measured: Up to 24 hours
Onset-to-needle time
The time between the symptom onset and the initiation of IVT
Measured: Up to 24 hours
modified Rankin Scale score at discharge
modified Rankin Scale score at discharge, on which scores range from 0 (no neurologic deficit) to 6 (death)
Measured: Up to 3 month
Symptomatic intracranial hemorrhage
Intracranial hemorrhage at 24 hours associated with an increase of ≥4 points of NIHSS score from baseline, according to European Cooperative Acute Stroke Study (ECASS) II trial
Measured: At 24 hours
Favorable neurological outcomes
Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)
Measured: At 90 days
Death
Death at discharge
Measured: Up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thrombolytic TherapyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,634 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing Second Hospital, Haiyan People's Hospital, Huzhou No.1 People' s Hospital, Jiashan No.1 People' s Hospital, Ningbo Medical Center Lihuili Hospital, Tongxiang No.1 People' s Hospital, First Affiliated Hospital of Wenzhou Medical University, Yiwu Central Hospital, Yongkang No.1 People' s Hospital, Yuyao People's Hospital, Deqing People' s Hospital, Dongyang People's Hospital, Jinhua People' s Hospital, Lishui People' s Hospital, Lin' an People' s Hospital, Longquan People' s Hospital, Qingtian People' s Hospital, Shaoxing Central Hospital, Wenzhou Central Hospital, Xiangshan No.1 People' s Hospital, The Central Hospital of Lishui City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317639
- Sponsor's protocol ID
- MISSION CHINA
- Status last verified
- Jan 2021
- First submitted
- 15 Oct 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lynch EA, Bulto LN, Cheng H, Craig L, Luker JA, Bagot KL, Thayabaranathan T, Janssen H, McInnes E, Middleton S, Cadilhac DA. Interventions for the uptake of evidence-based recommendations in acute stroke settings. Cochrane Database Syst Rev. 2023 Aug 11;8(8):CD012520. doi: 10.1002/14651858.CD012520.pub2.
PubMed 37565934Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial. PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul.
PubMed 35788767Wang J, Gong X, Zhong W, Zhou Y, Lou M. Novel Prehospital Triage Scale for Detecting Large Vessel Occlusion and Its Cause. J Am Heart Assoc. 2021 Sep 7;10(17):e021201. doi: 10.1161/JAHA.121.021201. Epub 2021 Aug 21.
PubMed 34423654
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
- ClinicalTrials.gov ID
- NCT03317639
- Acronym / sponsor ID
- MISSION CHINA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,634 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shaoxing Second Hospital, Haiyan People's Hospital, Huzhou No.1 People' s Hospital, Jiashan No.1 People' s Hospital, Ningbo Medical Center Lihuili Hospital, Tongxiang No.1 People' s Hospital, First Affiliated Hospital of Wenzhou Medical University, Yiwu Central Hospital, Yongkang No.1 People' s Hospital, Yuyao People's Hospital, Deqing People' s Hospital, Dongyang People's Hospital, Jinhua People' s Hospital, Lishui People' s Hospital, Lin' an People' s Hospital, Longquan People' s Hospital, Qingtian People' s Hospital, Shaoxing Central Hospital, Wenzhou Central Hospital, Xiangshan No.1 People' s Hospital, The Central Hospital of Lishui City
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. The randomisation will be conducted after one-year baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. Hospitals with no stroke centre or with <20 cases received thrombolysis per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage (post-intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| an intervention arm | Experimental | Behavioral: Behaviour Change Wheel model guided interventionHospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model |
| a control arm | No intervention | –hospitals in the control arm will receive no intervention and maintain existing care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- AIS patients receiving IVT within 4.5 hours
Key exclusion criteria (1 listed)
- Patients who are not willing to attend this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviour Change Wheel model guided interventionInterventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study. | Behavioural | an intervention arm |
Primary outcome
Difference in the percentage of patients who Door-to-Needle Time≤60min
Time frame: Up to 24 hours
Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage
6 secondary outcomes
Door-to-needle time
Time frame: Up to 24 hours
Onset-to-needle time
Time frame: Up to 24 hours
modified Rankin Scale score at discharge
Time frame: Up to 3 month
Symptomatic intracranial hemorrhage
Time frame: At 24 hours
Favorable neurological outcomes
Time frame: At 90 days
Death
Time frame: Up to 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 37565934Lynch EA, Bulto LN, Cheng H, Craig L, Luker JA, Bagot KL, Thayabaranathan T, Janssen H, McInnes E, Middleton S, Cadilhac DA. Interventions for the uptake of evidence-based recommendations in acute stroke settings. Cochrane Database Syst Rev. 2023 Aug 11;8(8):CD012520. doi: 10.1002/14651858.CD012520.pub2.
- Derived from this study: PubMed 35788767Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial. PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul.
- Derived from this study: PubMed 34423654Wang J, Gong X, Zhong W, Zhou Y, Lou M. Novel Prehospital Triage Scale for Detecting Large Vessel Occlusion and Its Cause. J Am Heart Assoc. 2021 Sep 7;10(17):e021201. doi: 10.1161/JAHA.121.021201. Epub 2021 Aug 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour Change Wheel model guided intervention in people with Thrombolytic Therapy and Acute Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the percentage of patients who Door-to-Needle Time≤60min (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317639, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.