Patient Centered CarePCCNCT00499161
Effect of Patient-Centered Care (PCC) on Patient Satisfaction at Hospital Discharge
A study testing New model of nursing care in people with Patient Centered Care, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this randomized clinical trial is to examine the effect of Patient-Centered Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare setting. Findings from this study will assist in determining if PCC, administered by nurses, should be instituted hospital wide. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patient Centered Care
- What is being tested?
- New model of nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Nov 2007
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Admitted to the service of Dr.RQ and scheduled for bariatric bypass surgery
- Expected length of hospital stay ≥ 2 days.
Who cannot join
- Any prior admission to the study unit
- Bariatric surgery performed by a surgeon other than Dr.RQ
- Scheduled to have a LAP Band procedure, as this procedure has a different postoperative course.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized clinical trial is to examine the effect of Patient-Centered Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare setting. Findings from this study will assist in determining if PCC, administered by nurses, should be instituted hospital wide.
SPECIFIC AIMS:
- To examine the effect of Patient-Centered Care on patient satisfaction.
- To examine the effect of Patient-Centered Care on the quality of patient care.
- To examine the effect of patient's perception of nursing care on patient satisfaction.
Read the detailed description
Patient-Centered Care (PCC), also known as individualized patient care or negotiated care, focuses on the patient's right to have his/her values and beliefs respected as an individual.This respect is viewed as part of a commitment to build a deep understanding of the patient as a thinking and feeling individual with the ability to change and develop. A person-centered model of care requires a nurse to work with an individual's beliefs, values, wants, needs and desires.This adaptation to a patient's personal needs requires the nurse to be flexible, respectful, and reciprocal when providing patient care. If the patient's expectations are not appropriate to the type of care needed to heal or if the patient refuses or denies a specific type of treatment that is known as influencing ones quality of care, the nurse must negotiate with the patient. Negotiation incorporates education, which is believed to increase the patient's level of understanding. In addition, negotiation allows the nurse and patient to define a level of treatment that is specific to the patient's needs but still seen as a quality indicator.
The Institute of Medicine (IOM) has listed PCC as one of six national quality aims for improvement. The IOM's vision is that all health professionals will be educated to provide and deliver PCC as part of an interdisciplinary team. In 2001, the IOM report "Crossing the Quality Chasm: A New Health System for the 21st Century" recommends a mixture of approaches to achieve their vision . These approaches include an appropriate training environment, research, public reporting and leadership. At present, there is little evidence to support the critical role nurse clinicians' play in providing PCC and satisfying patient's needs.
- Conditions
- Patient Centered Care
- Being tested
- New model of nursing care
- Keywords
- Individualized care, Relationship based care, Negotiated care, Patient focused care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New model of nursing careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control group received usual care |
| 2 | Experimental | Received intervention New model of nursing care Receives: Behavioral: New model of nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure level of overall satisfaction
Measured: day of discharge
Secondary outcomes (3)
Measure level of quality of care - 1)Length of stay, 2)infection, 3)falls
Measured: day of discharge and 7 days post discharge
measure satisfaction with nursing care
Measured: day of discharge
measure level of quality care (unplanned adverse events)
Measured: approximately 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Centered CareStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Debra M Wolf, MSN, Principal investigator, University of Pittsburh, School of Nursing & UPMC St. MargaretLisa Lehman, BSN, Principal investigator, University of PittsburghRobert Quinlin, MD, Principal investigator, University of PittsburghJodi Miller, BSN, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499161
- Sponsor's protocol ID
- PRO07030017
- Acronym
- PCC
- Status last verified
- Feb 2008
- First submitted
- 9 Jul 2007
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient-Centered Care (PCC) on Patient Satisfaction at Hospital Discharge
- ClinicalTrials.gov ID
- NCT00499161
- Acronym / sponsor ID
- PCC / PRO07030017
- Conditions
- Patient Centered Care
- Keywords
- Individualized care, Relationship based care, Negotiated care, Patient focused care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 11 Jul 2007 (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.
The purpose of this randomized clinical trial is to examine the effect of Patient-Centered Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare setting. Findings from this study will assist in determining if PCC, administered by nurses, should be instituted hospital wide.
SPECIFIC AIMS:
- To examine the effect of Patient-Centered Care on patient satisfaction.
- To examine the effect of Patient-Centered Care on the quality of patient care.
- To examine the effect of patient's perception of nursing care on patient satisfaction.
Detailed description
Patient-Centered Care (PCC), also known as individualized patient care or negotiated care, focuses on the patient's right to have his/her values and beliefs respected as an individual.This respect is viewed as part of a commitment to build a deep understanding of the patient as a thinking and feeling individual with the ability to change and develop. A person-centered model of care requires a nurse to work with an individual's beliefs, values, wants, needs and desires.This adaptation to a patient's personal needs requires the nurse to be flexible, respectful, and reciprocal when providing patient care. If the patient's expectations are not appropriate to the type of care needed to heal or if the patient refuses or denies a specific type of treatment that is known as influencing ones quality of care, the nurse must negotiate with the patient. Negotiation incorporates education, which is believed to increase the patient's level of understanding. In addition, negotiation allows the nurse and patient to define a level of treatment that is specific to the patient's needs but still seen as a quality indicator.
The Institute of Medicine (IOM) has listed PCC as one of six national quality aims for improvement. The IOM's vision is that all health professionals will be educated to provide and deliver PCC as part of an interdisciplinary team. In 2001, the IOM report "Crossing the Quality Chasm: A New Health System for the 21st Century" recommends a mixture of approaches to achieve their vision . These approaches include an appropriate training environment, research, public reporting and leadership. At present, there is little evidence to support the critical role nurse clinicians' play in providing PCC and satisfying patient's needs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control group received usual care |
| 2 | Experimental | Behavioral: New model of nursing careReceived intervention New model of nursing care |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Admitted to the service of Dr.RQ and scheduled for bariatric bypass surgery
- Expected length of hospital stay ≥ 2 days.
Key exclusion criteria (3 listed)
- Any prior admission to the study unit
- Bariatric surgery performed by a surgeon other than Dr.RQ
- Scheduled to have a LAP Band procedure, as this procedure has a different postoperative course.
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 |
|---|---|---|
| New model of nursing care | Behavioural | 2 |
Primary outcome
Measure level of overall satisfaction
Time frame: day of discharge
3 secondary outcomes
Measure level of quality of care - 1)Length of stay, 2)infection, 3)falls
Time frame: day of discharge and 7 days post discharge
measure satisfaction with nursing care
Time frame: day of discharge
measure level of quality care (unplanned adverse events)
Time frame: approximately 30 days post discharge
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 18 Feb 2008.
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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.
Debra M Wolf, MSN principal investigator
University of Pittsburh, School of Nursing & UPMC St. Margaret
Lisa Lehman, BSN principal investigator
University of Pittsburgh
Robert Quinlin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New model of nursing care in people with Patient Centered Care, run by University of Pittsburgh at 1 site in United States.
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 3 inclusion and 3 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 18 Feb 2008. 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 States. 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?
Measure level of overall satisfaction (time frame: day of discharge). 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 18 Feb 2008.