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Emergency Service, HospitalBACOPNCT01540266

Basel Discharge Communication Project

A study testing Information structuring and no information structuring in people with Emergency Service, Hospital and Information Structuring, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assessing whether structuring of discharge information improves the sender's recall capacity Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Information structuring and no information structuring
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
1 siteSwitzerland
Study dates
Jul 2011to Oct 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion criteria Students of Psychology and Medicine from the Universities of Basel, Switzerland, and Mannheim, Germany

Exclusion criteria Participants being younger than 18 years will not be included because of limited ability to give informed consent.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital

    Basel, 4031

Other trials in Switzerland

About this study

Official title: BACOP - Basel Discharge Communication Project - Study 3

Assessing whether structuring of discharge information improves the sender's recall capacity

Read the detailed description

RATIONALE However essential the transferred information at discharge might be, it can only have a positive effect on the patient if he or she recalls its content after discharge. Little is known about patients' ability to subsequently recall instructions received during hospital discharge (Sanderson, Thompson, Brown, Tucker, \& Bittner, 2009). Using telephone interviews to gauge the ability to recall discharge instructions, Sanderson et al. (2009) found that many patients were unable to even name their diagnosis or list risk factors as contributing causes. Examining elderly patients' comprehension of discharge instructions, a further study found that 21% did not understand their diagnosis, and 56% failed to comprehend their return instructions (Hastings et al., 2011). A study of Chau et al. (2011) showed that even immune-compromised patient's knowledge of oral drugs at discharge was merely moderate. Finally, Isaacman et al. (1992) observed that less than half of the important discharge information, including medication details and indicators of worsening of the patient's clinical status, was recalled during an exit interview. These few available findings suggest that there is ample room for discharge communication to be optimized and for finding and testing techniques to do so.

As psychological theory and associated empirical findings suggest that information structuring can be a powerful tool in improving memory recall and understanding, the question has been raised whether structuring the information conveyed during the discharge communication could also improve patients' memory of the respective content. Few researchers (Doak, Doak, Friedell, \& Meade, 1998; Ley, 1979) have suggested that structuring communications in a clinical setting could improve patients' recall. They argue that structured information would be easier to recall than nonstructured information; however, these authors did not provide strong evidence to support this hypothesis. Furthermore, structured approaches and tools may provide support for physicians in increasing communication competences and potential solutions to improve the quality of communication and prevent subsequent patient harm. To date, only a few attempts have been made to investigate whether conveying information in a structured way results in better outcomes, measured in terms of learning and recall. The power of information structuring and associated chunking mechanisms has primarily been studied in the laboratory; no previous studies have investigated its role in improving discharge information delivery. Could information structuring also improve patients' recall and understanding of discharge information? If so, how should physicians best structure information at discharge to achieve these goals? How do possible effects on patients' recall translate to better adherence to recommendations? Studying these questions experimentally in the Emergency Department (ED) would be demanding and potentially stressful for ED patients. In a first step, we therefore decided to take advantage of students as proxy patients. Various previous studies have used proxies (mostly health care professionals or family caregivers) to evaluate certain patient outcomes (such as health-related quality of life (Pickard \& Knight, 2005), functional ability (Loewenstein et al., 2001), or symptoms(Nekolaichuk et al., 1999)). To our knowledge no previous study has used students as proxies to gauge the recall performance of patients.

Prior knowledge facilitates the processing of new incoming information by providing a structure into which new information can be integrated (Brod, Werkle-Bergner, \& Shing, 2013); therefore, structured incoming information should not be recalled better than nonstructured information by individuals who can build upon prior knowledge. If there is, by contrast, no internal structure because of absent prior knowledge, externally imposed structure could yield similar benefits. Thus, the extent to which the possible superiority of a structured presentation of ED discharge information over a nonstructured presentation relates to relevant prior medical knowledge was the secondary goal of this study. Or, in other words, could the availability of relevant prior knowledge enable the receiver of information to store it efficiently, even when its presentation lacks structure? To answer this question, we recruited, besides the first-year psychology students, two additional independent populations, namely first-year medical students and third-year medical students. Specifically, the three participant groups differed notably in their knowledge of cardiac pain (first-year psychology students < first-year medical students < third-year medical students).

TRIAL OBJECTIBVES Primary objective First, assuming that externally imposed structure yields benefits in terms of memory performance if internal structure is unavailable, the goal of this study is to investigate whether first-year psychology students, i.e. students with little to no prior medical knowledge, who serve as surrogate patients, recall more information when it is presented in a structured way as compared to a nonstructured presentation. Second, assuming that structure should benefit mostly those individuals who cannot make use of previous knowledge to build memory chunks and to better control the experimental setup between the two parameters "structure" and "prior medical knowledge", we set out to oppose various degrees of relevant prior medical knowledge to structured and nonstructured content presentation, respectively.

Secondary objectives

  1. To compare differences between the structured and nonstructured conditions in terms of participants' ratings of the comprehensibility of the physician, the structure of the dialogue, and their willingness to recommend the physician to friends and relatives.
  2. To establish whether the effect of information structuring on the number of recalled items is independent from the influence from the students' current mood and level of attention.

TRIAL ENDPOINTS Primary endpoint Number of items recalled, separately for the structured and the nonstructured condition as well as for the three participating groups Secondary endpoints Visual analog scale (VAS) measures of participants' current mood, level of attention (to test for moderating effects of the students' status), and ratings of the comprehensibility of the physician, the structure of the dialogue, willingness to recommend the physician to friends and relatives.

TRIAL DESIGN AND METHODS Trial design Prospective cross-sectional multicenter trial Participating sites University of Mannheim, Germany University of Basel, Switzerland Study schedule Participants We will recruit students during regular lectures at the University of Basel, Switzerland, and Mannheim, Germany. Psychology students will receive course credit for participation. Participants being younger than 18 years will not be included because of limited ability to give informed consent.

Study Procedure The study will be conducted in each two quiet auditoriums of the Universities of Basel (for first-year psychology students and third year medical students), and Mannheim (for first year medical students). We will randomly divide participants into the structured and the nonstructured condition, respectively. At the outset, after giving informed consent, participants of both conditions will be instructed that they are about to watch a video of a physician-patient interaction, requesting them to take the perspective of the patient. After that, a video displaying an experienced emergency physician who orally presents structured content to a patient will be shown to one group. A second video displaying the same emergency physician, presenting the same content, but in a nonstructured manner, will be shown to the other group. We will then confront the students with a blank piece of paper, and we will ask them to mark everything occurring to them concerning the communication (immediate recall). Informed students will observe their peers in order to inhibit taking notes. After that, students of both conditions will be confronted with a multiple choice test that was constructed in order to measure students' medical knowledge, and five VASs in order to assess the secondary endpoints. Information about demographic variables will be collected in conclusion.

Data Analysis Primary endpoint is the recall performance of the participants expressed as the number of items remembered from the discharge communication. In a primary, un-adjusted analysis, the difference in recall performance between the two groups receiving structured and nonstructured discharge information, and the three groups with different levels of medical knowledge, as well as their interaction, will be analyzed using an analysis of variance (ANOVA). In addition, an analysis of covariance (ANCOVA), which adjusts for the two VAS measures concerning students' status, will be performed. Non-parametric Mann-Whitney tests will be performed to probe for inter- and intragroup differences in medical knowledge of first-year psychology students, first-year medical students, and third-year medical students. A t-test analysis will be used to compare differences between the structured and non-structured conditions in terms of participants' VAS ratings of the comprehensibility of the physician, the structure of the dialogue, and willingness to recommend the physician to friends and relatives. All tests will be performed using a significance level α = 0.05.

Being tested
Information structuring, no information structuring
Keywords
physician-patient communication, information structuring, emergency department
Medical subject headings
Emergencies, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Information structuringProcedure or surgery

    Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form

  • no information structuringProcedure or surgery

    Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form

Study groups in NCT01540266
Study groupRoleWhat they receive
first year psychology_structuredExperimentalFirst year psychology students who watched the video where the physician gives structured information to the patient
Receives: Procedure: Information structuring
First year psychology_non-structuredActive comparatorFirst year psychology students who watched the video where the physician gives non-structured information to the patient
Receives: Procedure: no information structuring
First year medical_structuredExperimentalFirst year medical students who watched the video where the physician gives structured information to the patient
Receives: Procedure: Information structuring
First year mediclal_non-structuredActive comparatorFirst year medical students who watched the video where the physician gives non-structured information to the patient
Receives: Procedure: no information structuring
Third year medical_structuredExperimentalThird year medical students who watched the video where the physician gives structured information to the patient
Receives: Procedure: Information structuring
Third year medical_non-structuredActive comparatorThird year medical students who watched the video where the physician gives non-structured information to the patient
Receives: Procedure: no information structuring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Items Recalled From the Communication in the Video

    The students in the structured condition and the students in the non-structured condition were independently shown a video in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form. The key memory measure of interest was immediate recall performance expressed as the number of items recalled from the overall 28 items in the two videos. Participants' recall protocols were evaluated by two independent raters, one of whom rated all protocols and the other, only a subset of them. Analyses of the agreement between the two raters resulted in a Cohen's kappa of 0.74, indicating substantial interrater reliability according to Landis and Koch (35). In case of disagreement between the two raters, consensus was reached through joint analysis and discussion of the protocols.

    Measured: 5 minutes

Secondary outcomes (2)
  1. Estimates of the Quality of the Communication

    Measured: 5 minutes

  2. Estimates of the Current Status

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2012 (estimated)
  2. Study startJul 2011
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01540266
Sponsor's protocol ID
CR13I3_140651
Acronym
BACOP
Status last verified
Mar 2015
First submitted
22 Feb 2012
Last updated
31 Mar 2015
Data monitoring committee
Yes

Publications

  • Brod G, Werkle-Bergner M, Shing YL. The influence of prior knowledge on memory: a developmental cognitive neuroscience perspective. Front Behav Neurosci. 2013 Oct 8;7:139. doi: 10.3389/fnbeh.2013.00139.

    PubMed 24115923
  • Chau I, Korb-Savoldelli V, Trinquart L, Caruba T, Prognon P, Durieux P, Piketty C, Sabatier B. Knowledge of oral drug treatment in immunocompromised patients on hospital discharge. Swiss Med Wkly. 2011 Jun 24;141:w13204. doi: 10.4414/smw.2011.13204. eCollection 2011.

    PubMed 21706451
  • Hastings SN, Barrett A, Weinberger M, Oddone EZ, Ragsdale L, Hocker M, Schmader KE. Older patients' understanding of emergency department discharge information and its relationship with adverse outcomes. J Patient Saf. 2011 Mar;7(1):19-25. doi: 10.1097/PTS.0b013e31820c7678.

    PubMed 21921863
  • Isaacman DJ, Purvis K, Gyuro J, Anderson Y, Smith D. Standardized instructions: do they improve communication of discharge information from the emergency department? Pediatrics. 1992 Jun;89(6 Pt 2):1204-8.

    PubMed 1594378
  • Loewenstein DA, Arguelles S, Bravo M, Freeman RQ, Arguelles T, Acevedo A, Eisdorfer C. Caregivers' judgments of the functional abilities of the Alzheimer's disease patient: a comparison of proxy reports and objective measures. J Gerontol B Psychol Sci Soc Sci. 2001 Mar;56(2):P78-84. doi: 10.1093/geronb/56.2.p78.

    PubMed 11245361
  • Nekolaichuk CL, Bruera E, Spachynski K, MacEachern T, Hanson J, Maguire TO. A comparison of patient and proxy symptom assessments in advanced cancer patients. Palliat Med. 1999 Jul;13(4):311-23. doi: 10.1191/026921699675854885.

    PubMed 10659100
  • Pickard AS, Knight SJ. Proxy evaluation of health-related quality of life: a conceptual framework for understanding multiple proxy perspectives. Med Care. 2005 May;43(5):493-9. doi: 10.1097/01.mlr.0000160419.27642.a8.

    PubMed 15838415
  • Sanderson BK, Thompson J, Brown TM, Tucker MJ, Bittner V. Assessing patient recall of discharge instructions for acute myocardial infarction. J Healthc Qual. 2009 Nov-Dec;31(6):25-33; quiz 34. doi: 10.1111/j.1945-1474.2009.00052.x.

    PubMed 19957461
  • Ackermann S, Heierle A, Bingisser MB, Hertwig R, Padiyath R, Nickel CH, Langewitz W, Bingisser R. Discharge Communication in Patients Presenting to the Emergency Department With Chest Pain: Defining the Ideal Content. Health Commun. 2016;31(5):557-65. doi: 10.1080/10410236.2014.979115. Epub 2015 Oct 26.

    PubMed 26503453

Questions about this trial

What is this clinical trial studying?

A study testing Information structuring and no information structuring in people with Emergency Service, Hospital and Information Structuring, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 31 Mar 2015. 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 Switzerland. 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?

Yes. Results are posted in the registry (first posted 31 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Items Recalled From the Communication in the Video (time frame: 5 minutes). 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 NCT01540266, which also lists 9 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 31 Mar 2015.

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