AttitudeHiSLACNCT03962192
Attitudinal Measures Survey With HISLAC Physicians (SURVEY ONLY)
A study testing Attitudinal measures in people with Attitude and Risk-Taking, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
HiSLAC is an independent, professionally-led study which will evaluate a key component of NHS England's policy drive for 7-day services: the intensity of specialist-led care of emergency medical admissions, with a particular focus on weekend provision. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Attitude, Risk-Taking
- What is being tested?
- Attitudinal measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2019to 30 Apr 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- case note reviewer involved in the HiSLAC study (including those partly reviewing their apportioned cases.)
Who cannot join
- participants not involved at the outset or at any point during the HiSLAC case note reviews
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Applied Health Research, University of Birmingham
Birmingham, B19 1HR
About this study
Official title: High-Intensity Specialist-Led Acute Care (HiSLAC) Project
HiSLAC is an independent, professionally-led study which will evaluate a key component of NHS England's policy drive for 7-day services: the intensity of specialist-led care of emergency medical admissions, with a particular focus on weekend provision. This research is important for patients and for NHS strategy because it offers a unique opportunity to evaluate the impact of the transition to seven-day working, and to understand factors likely to impede or enhance the effectiveness of this change in practice.
In addition to examining the impact on patient-centred outcomes, the project will also undertake a health economics analysis of the impact of increasing specialist provision across the NHS. HiSLAC will therefore provide useful information across the NHS about the cost-effectiveness of investing in consultant and other specialist staffing in implementing the drive to 7-day service provision.
In this survey instrument, physician characteristics and psychological attitudes have been shown to influence medical decisions. This study aims to describe the influence of several patient characteristics and reviewer characteristics and attitudes on the physician's overall case note review care quality judgement using an analytical method called multi-level modelling.
Read the detailed description
The investigators describe here a protocol for comparing quality of care given to patients admitted as emergencies to 20 hospital Trusts at weekends and on weekdays during two epochs, representing periods before (2012-2013) and during (2016-2017) the implementation of NHS England's 7-day services standards.
Using retrospective review of case records from 20 hospital Trusts during two time epochs, this study aims to determine whether there is a difference in quality of care offered to patients undergoing emergency admission (EA) to hospital at weekends compared with weekdays.
The main objectives are as follows:
- To compare rates of errors and differences in care quality between weekend and weekday admissions,
- To examine prevalent error types for weekend and weekday admissions,
- If a difference in error rates or care quality between weekend and weekday admissions is found, examine whether the difference has changed between the two epochs.
- To inform the Bayesian model proposed in this parallel health economics model. The co-primary outcomes are the weekend:weekday error rate ratio and the global assessment of care quality. The error rate is calculated as the number of errors per case record from admission to discharge or to 7 days, whichever occurs first.
Secondary outcomes include a comparison of weekend-weekday admissions in error typology and error-related adverse events (AEs), of error rates by day of the week within each admission group and correlation of weekend: weekday error rate ratios with weekend:weekday differences in specialist hours per 10 EAs.
In this survey instrument, physician characteristics and psychological attitudes have shown to influence medical decisions. The case note review process of determining the overall care quality is a type of medical decision. The HiSLAC study gives us an opportunity to determine whether patient or physician characteristics and physician attitudinal scores (physician aversion to ambiguity, need for cognition and personal need for structure) influence the overall care quality judgement during case note review. The investigators develop a case for considering this question with a multi-level model assuming the clustering within patient and within reviewers; furthermore, the investigators develop pre-specified hypotheses for testing. (See hypotheses) Our outputs from this are intended to inform better practice with case note reviews.
HYPOTHESES
For each objective a general hypothesis is provided:
Null hypothesis 1: To assess whether there is no significant relationship between patient case note characteristics and the physician's overall care quality judgements.
Null hypothesis 2: To assess whether there is no significant relationship between case note reviewer characteristics and their overall care quality judgements.
Null hypothesis 3. To assess whether there is no significant relationship between case note reviewer attitudes and their overall care quality judgements.
In addition to the above two objectives, one secondary objective is to assess the same effects of characteristics and attitudes on reviewer confidence in their care quality judgement. A further secondary objective is to assess whether there is a significant relationship between case-specific factors and reviewers' self-assessed confidence in their global care quality judgements.
- Conditions
- Attitude, Risk-Taking
- Being tested
- Attitudinal measures
- Medical subject headings
- Behavior, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attitudinal measuresOther
A collection of 3 distinct attitudinal instruments comprise this survey.
| Study group | Role | What they receive |
|---|---|---|
| Survey tools | Experimental | Survey instruments are shared with reviewers. Receives: Other: Attitudinal measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need For Cognition (NFC) Scale (5 items on 6 point Likert)
Assessing the individual's tendency to engage in and enjoy activities that require thinking. Minimum score is 1 and the maximum is 6 (other than for items 3 and 4 which are each reverse scored; i.e. 6 is the lowest score and 1 is the highest score possible) There is no moral distinction about which score is better; they are measures of attitudinal predispositions individuals have in a respective scenario. It is then our remit to parse this information in light of the context, the nature of the participants and the overall aims and boundaries of reviewing case notes. (e.g. a higher value (thus preferring more complex situations) on 'I would prefer complex to simple problems' does not necessarily indicate a 'good' response but more that they are compelled by difficult and complex problems.
There are no subscales to consider; items are equally weighted contributing to the distinction between low and high NFC i.e. top half or the bottom half of all possible scores.
Measured: 3 weeks from survey commencement
Personal Need for Structure (PNS) Scale (12 items on 6 point Likert)
Assessing preferences for "structure and clarity in most situations, with ambiguity and grey areas proving troublesome and annoying." Minimum score is 1 and the maximum is 6 (other than for items 2, 5, 6 and 11 which are each reverse scored; i.e. 6 is the lowest score and 1 is the highest score possible) There is no moral distinction about which score is better; they are measures of attitudinal predispositions individuals have. Investigators then parse this information in light of the context, the nature of the participants and the overall aims and boundaries of reviewing case notes. (e.g. a higher value (thus preferring more complex situations) on 'I enjoy having a structured mode of life.' does not necessarily indicate a 'good' response but more that they desire more structure in their work.
There are no subscales to consider for PNS; items are equally weighted contributing to the distinction between low and high PNS i.e. in the top half or the bottom half of all possible scores.
Measured: 3 weeks from survey commencement
Anxiety due to uncertainty Scale (ADTU) (5 items on 6 point Likert)
One subscale (total=4) of 'Revised Physician's reactions to uncertainty scale' assessing physicians" affective reactions to uncertainty.
Minimum score is 1 and the maximum is 6 (other than for items 2, 5, 6 and 11 which are each reverse scored; i.e. 6 is the lowest score and 1 is the highest score possible) There is no moral distinction about which score is better; they are measures of attitudinal predispositions individuals have. It is then our remit to parse this information in light of the case note review context. (e.g. a higher value (thus preferring more complex situations) on 'I am quite comfortable with the uncertainty in patient care' does not necessarily indicate a 'better' response but more that they are more comfortable with uncertainty in their clinical work.
ADTU is a subscale of the a larger instrument; items are equally weighted contributing to the distinction between low and high ADTU i.e. in the top half or the bottom half of all possible scores.
Measured: 3 weeks from survey commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start30 Apr 2019
- Primary completion3 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttitudeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An attitudinal survey will be completed by approximately 80 case note reviewers within the HiSLAC project
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962192
- Sponsor's protocol ID
- RG_13-251
- Acronym
- HiSLAC
- Status last verified
- Apr 2019
- First submitted
- 3 May 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to share the information once the data has been collected and cleaned. Researchers will be contacted to determine the next steps to be taken with the data. Analysis will occur and this will be shared with participants and researchers alike.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Specialist-Led Acute Care (HiSLAC) Project
- ClinicalTrials.gov ID
- NCT03962192
- Acronym / sponsor ID
- HiSLAC / RG_13-251
- Conditions
- Attitude, Risk-Taking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 23 May 2019 (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.
HiSLAC is an independent, professionally-led study which will evaluate a key component of NHS England's policy drive for 7-day services: the intensity of specialist-led care of emergency medical admissions, with a particular focus on weekend provision. This research is important for patients and for NHS strategy because it offers a unique opportunity to evaluate the impact of the transition to seven-day working, and to understand factors likely to impede or enhance the effectiveness of this change in practice.
In addition to examining the impact on patient-centred outcomes, the project will also undertake a health economics analysis of the impact of increasing specialist provision across the NHS. HiSLAC will therefore provide useful information across the NHS about the cost-effectiveness of investing in consultant and other specialist staffing in implementing the drive to 7-day service provision.
In this survey instrument, physician characteristics and psychological attitudes have been shown to influence medical decisions. This study aims to describe the influence of several patient characteristics and reviewer characteristics and attitudes on the physician's overall case note review care quality judgement using an analytical method called multi-level modelling.
Detailed description
The investigators describe here a protocol for comparing quality of care given to patients admitted as emergencies to 20 hospital Trusts at weekends and on weekdays during two epochs, representing periods before (2012-2013) and during (2016-2017) the implementation of NHS England's 7-day services standards.
Using retrospective review of case records from 20 hospital Trusts during two time epochs, this study aims to determine whether there is a difference in quality of care offered to patients undergoing emergency admission (EA) to hospital at weekends compared with weekdays.
The main objectives are as follows:
- To compare rates of errors and differences in care quality between weekend and weekday admissions,
- To examine prevalent error types for weekend and weekday admissions,
- If a difference in error rates or care quality between weekend and weekday admissions is found, examine whether the difference has changed between the two epochs.
- To inform the Bayesian model proposed in this parallel health economics model. The co-primary outcomes are the weekend:weekday error rate ratio and the global assessment of care quality. The error rate is calculated as the number of errors per case record from admission to discharge or to 7 days, whichever occurs first.
Secondary outcomes include a comparison of weekend-weekday admissions in error typology and error-related adverse events (AEs), of error rates by day of the week within each admission group and correlation of weekend: weekday error rate ratios with weekend:weekday differences in specialist hours per 10 EAs.
In this survey instrument, physician characteristics and psychological attitudes have shown to influence medical decisions. The case note review process of determining the overall care quality is a type of medical decision. The HiSLAC study gives us an opportunity to determine whether patient or physician characteristics and physician attitudinal scores (physician aversion to ambiguity, need for cognition and personal need for structure) influence the overall care quality judgement during case note review. The investigators develop a case for considering this question with a multi-level model assuming the clustering within patient and within reviewers; furthermore, the investigators develop pre-specified hypotheses for testing. (See hypotheses) Our outputs from this are intended to inform better practice with case note reviews.
HYPOTHESES
For each objective a general hypothesis is provided:
Null hypothesis 1: To assess whether there is no significant relationship between patient case note characteristics and the physician's overall care quality judgements.
Null hypothesis 2: To assess whether there is no significant relationship between case note reviewer characteristics and their overall care quality judgements.
Null hypothesis 3. To assess whether there is no significant relationship between case note reviewer attitudes and their overall care quality judgements.
In addition to the above two objectives, one secondary objective is to assess the same effects of characteristics and attitudes on reviewer confidence in their care quality judgement. A further secondary objective is to assess whether there is a significant relationship between case-specific factors and reviewers' self-assessed confidence in their global care quality judgements.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An attitudinal survey will be completed by approximately 80 case note reviewers within the HiSLAC project
| Arm | Type | Receives |
|---|---|---|
| Survey tools | Experimental | Other: Attitudinal measuresSurvey instruments are shared with reviewers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- case note reviewer involved in the HiSLAC study (including those partly reviewing their apportioned cases.)
Key exclusion criteria (1 listed)
- participants not involved at the outset or at any point during the HiSLAC case note reviews
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 |
|---|---|---|
| Attitudinal measuresA collection of 3 distinct attitudinal instruments comprise this survey. | Other | Survey tools |
Primary outcome
Need For Cognition (NFC) Scale (5 items on 6 point Likert)
Time frame: 3 weeks from survey commencement
Assessing the individual's tendency to engage in and enjoy activities that require thinking. Minimum score is 1 and the maximum is 6 (other than for items 3 and 4 which are each reverse scored; i.e. 6 is the lowest score and 1 is the highest score possible) There is no moral distinction about which score is better; they are measures of attitudinal predispositions individuals have in a respective scenario. It is then our remit to parse this information in light of the context, the nature of the participants and the overall aims and boundaries of reviewing case notes. (e.g. a higher value (thus preferring more complex situations) on 'I would prefer complex to simple problems' does not necessarily indicate a 'good' response but more that they are compelled by difficult and complex problems. There are no subscales to consider; items are equally weighted contributing to the distinction between low and high NFC i.e. top half or the bottom half of all possible scores.
Personal Need for Structure (PNS) Scale (12 items on 6 point Likert)
Time frame: 3 weeks from survey commencement
Assessing preferences for "structure and clarity in most situations, with ambiguity and grey areas proving troublesome and annoying." Minimum score is 1 and the maximum is 6 (other than for items 2, 5, 6 and 11 which are each reverse scored; i.e. 6 is the lowest score and 1 is the highest score possible) There is no moral distinction about which score is better; they are measures of attitudinal predispositions individuals have. Investigators then parse this information in light of the context, the nature of the participants and the overall aims and boundaries of reviewing case notes. (e.g. a higher value (thus preferring more complex situations) on 'I enjoy having a structured mode of life.' does not necessarily indicate a 'good' response but more that they desire more structure in their work. There are no subscales to consider for PNS; items are equally weighted contributing to the distinction between low and high PNS i.e. in the top half or the bottom half of all possible scores.
Anxiety due to uncertainty Scale (ADTU) (5 items on 6 point Likert)
Time frame: 3 weeks from survey commencement
One subscale (total=4) of 'Revised Physician's reactions to uncertainty scale' assessing physicians" affective reactions to uncertainty. Minimum score is 1 and the maximum is 6 (other than for items 2, 5, 6 and 11 which are each reverse scored; i.e. 6 is the lowest score and 1 is the highest score possible) There is no moral distinction about which score is better; they are measures of attitudinal predispositions individuals have. It is then our remit to parse this information in light of the case note review context. (e.g. a higher value (thus preferring more complex situations) on 'I am quite comfortable with the uncertainty in patient care' does not necessarily indicate a 'better' response but more that they are more comfortable with uncertainty in their clinical work. ADTU is a subscale of the a larger instrument; items are equally weighted contributing to the distinction between low and high ADTU i.e. in the top half or the bottom half of all possible scores.
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 5 Nov 2020.
- HiSLAC Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The plan is to share the information once the data has been collected and cleaned. Researchers will be contacted to determine the next steps to be taken with the data. Analysis will occur and this will be shared with participants and researchers alike.
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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 Attitudinal measures in people with Attitude and Risk-Taking, run by University of Birmingham at 1 site in United Kingdom.
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 5 Nov 2020. 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 United Kingdom. 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?
Need For Cognition (NFC) Scale (5 items on 6 point Likert) (time frame: 3 weeks from survey commencement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.