Patient-Centered CareNCT01542112
An Innovational Model to Manage Patient Expectations and Improve Patient Satisfaction: An Intervention Study
A study testing PSactive model and No treatment in people with Patient-Centered Care and Patient Satisfaction, run by University of Aarhus at 1 site in Denmark.
Trial summary
This new model to manage patient expectations was developed based on our international study conducted in four countries. The model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient-Centered Care, Patient Satisfaction
- What is being tested?
- PSactive model and No treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 835 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Oct 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patient older than 17 years who are able to express their expectations and needs to the clinicians and further have the ability to understand and fill in a questionnaire
Who cannot join
- Patients who are demented
Trial locations and contacts
1 site in 1 country.
About this study
This new model to manage patient expectations was developed based on our international study conducted in four countries. The model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and needs and thereby, improve patient satisfaction.
The interventional model comprise teachable-learnable communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, Respond, Provide relevant information and Document the intervention.
Read more
The intervention includes all frontline care givers; however, most of the activities will be done by the nursing staff. The set of activities will be executed by the nurses at three separate periods of time during the patient's hospitalization: time of admission, intermediate time and at time of discharge.
The study is based on the hypothesis that a structured interventional model will significantly improve patient satisfaction during hospitalization.
- Conditions
- Patient-Centered Care, Patient Satisfaction
- Being tested
- PSactive model, No treatment
- Keywords
- Patient-Centered Care, Patient Satisfaction, Interventional study, Patient Expectations, Hospitalization
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSactive modelOther
The model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and improve patient satisfaction.
The interventional model is comprised of teachable-learnable interpersonal communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, respond, provide relevant information and document the intervention.
No treatmentOther
Patients in this arm receive the usual routine in the department.
| Study group | Role | What they receive |
|---|---|---|
| PSactive model | Experimental | The model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and improve patient satisfaction.
The interventional model is comprised of teachable-learnable interpersonal communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, respond, provide relevant information and document the intervention. Receives: Other: PSactive model |
| No treament | Experimental | Usual routine in the department Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of satisfaction with the hospitalization.
We will use the Danish National Patient Satisfaction Survey Instrument(20 questions)supplemented with 17 validated questions related to patient expectations, satisfaction and demographic data.
The primary question is:
In general, to what extent did your entire experience during the hospitalization meet your expectations? Using any number from 0 to 10, where 0 represents that your expectations were completely unmet and 10 represents that your expectations were completely met - what number would you use to rate this hospital stay?
Measured: A questionnaire will be handed directly to the included patients after discharge has been ordered by a physician. The time frame for outcome measuring is anticipated to be within an average of 1-6 hours before the patient leaves the department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient-Centered CareStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Ronen Rozenblum, PhD, Principal investigator, Division of General Internal Medicine, Brigham and Womens Hospital, Harvard Medical School, 1620 Tremont Street, BS-3, Boston 02120, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542112
- Sponsor's protocol ID
- Patient-Centered care
- Other IDs
- AUH
- Status last verified
- Mar 2013
- First submitted
- 13 Feb 2012
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rozenblum R, Lisby M, Hockey PM, Levtizion-Korach O, Salzberg CA, Lipsitz S, Bates DW. Uncovering the blind spot of patient satisfaction: an international survey. BMJ Qual Saf. 2011 Nov;20(11):959-65. doi: 10.1136/bmjqs-2011-000306. Epub 2011 Sep 22.
PubMed 21949436
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovational Model to Manage Patient Expectations and Improve Patient Satisfaction: An Intervention Study
- ClinicalTrials.gov ID
- NCT01542112
- Acronym / sponsor ID
- Patient-Centered care
- Conditions
- Patient-Centered Care, Patient Satisfaction
- Keywords
- Patient-Centered Care, Patient Satisfaction, Interventional study, Patient Expectations, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Mar 2012 (estimated)
- 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.
This new model to manage patient expectations was developed based on our international study conducted in four countries. The model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and needs and thereby, improve patient satisfaction.
The interventional model comprise teachable-learnable communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, Respond, Provide relevant information and Document the intervention.
The intervention includes all frontline care givers; however, most of the activities will be done by the nursing staff. The set of activities will be executed by the nurses at three separate periods of time during the patient's hospitalization: time of admission, intermediate time and at time of discharge.
The study is based on the hypothesis that a structured interventional model will significantly improve patient satisfaction during hospitalization.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSactive model | Experimental | Other: PSactive modelThe model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and improve patient satisfaction. The interventional model is comprised of teachable-learnable interpersonal communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, respond, provide relevant information and document the intervention. |
| No treament | Experimental | Other: No treatmentUsual routine in the department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patient older than 17 years who are able to express their expectations and needs to the clinicians and further have the ability to understand and fill in a questionnaire
Key exclusion criteria (1 listed)
- Patients who are demented
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 |
|---|---|---|
| PSactive modelThe model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and improve patient satisfaction. The interventional model is comprised of teachable-learnable interpersonal communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, respond, provide relevant information and document the intervention. | Other | PSactive model |
| No treatmentPatients in this arm receive the usual routine in the department. | Other | No treament |
Primary outcome
Level of satisfaction with the hospitalization.
Time frame: A questionnaire will be handed directly to the included patients after discharge has been ordered by a physician. The time frame for outcome measuring is anticipated to be within an average of 1-6 hours before the patient leaves the department.
We will use the Danish National Patient Satisfaction Survey Instrument(20 questions)supplemented with 17 validated questions related to patient expectations, satisfaction and demographic data. The primary question is: In general, to what extent did your entire experience during the hospitalization meet your expectations? Using any number from 0 to 10, where 0 represents that your expectations were completely unmet and 10 represents that your expectations were completely met - what number would you use to rate this hospital stay?
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 6 Mar 2013.
- Background: PubMed 21949436Rozenblum R, Lisby M, Hockey PM, Levtizion-Korach O, Salzberg CA, Lipsitz S, Bates DW. Uncovering the blind spot of patient satisfaction: an international survey. BMJ Qual Saf. 2011 Nov;20(11):959-65. doi: 10.1136/bmjqs-2011-000306. Epub 2011 Sep 22.
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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.
Ronen Rozenblum, PhD principal investigator
Division of General Internal Medicine, Brigham and Womens Hospital, Harvard Medical School, 1620 Tremont Street, BS-3, Boston 02120, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSactive model and No treatment in people with Patient-Centered Care and Patient Satisfaction, run by University of Aarhus at 1 site in Denmark.
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 6 Mar 2013. 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 Denmark. 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?
Level of satisfaction with the hospitalization. (time frame: A questionnaire will be handed directly to the included patients after discharge has been ordered by a physician. The time frame for outcome measuring is anticipated to be within an average of 1-6 hours before the patient leaves the department.). 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 NCT01542112, which also lists 1 linked publication.
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 6 Mar 2013.