Medical OncologyNCT02906423
Results From a Health System-wide Implementation of a Quality of Life Questionnaire
An observational study of Medical Oncology and Cardiology, run by Allina Health System at 1 site in United States.
Trial summary
The purpose of this retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Oncology, Cardiology, Integrative Medicine
- What is being tested?
- PROMIS-10 questionnaire
- How many people
- 43,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is a retrospective chart review of up to 75,000 patients seen at an Allina Health facility who completed a Patient Reported Outcomes Measurement Information System Global Short Form (PROMIS-10) questionnaire between July 1, 2012 and December 31, 2016. Service line programs in which this questionnaire was deployed included the following: cardiac rehabilitation, heart failure, care management, physical and mental rehabilitation, integrative medicine, oncology, orthopedic, palliative care, pulmonary rehabilitation, primary care, and spine. Patients over 17 years of age who completed a PROMIS-10 questionnaire in an Allina Health clinic between July 1, 2012 and December 31, 2016 will be included in the study.
Who may be able to join
- patients seen at an Allina Health outpatient facility who complete a PROMIS-10 questionnaire between July 1, 2012 and December 31, 2016.
Who cannot join
- patients who did not allow their records to be used for research purposes are not included in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
The purpose of this retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on QOL scores. The results will provide insight into QOL trends within different patient populations and provide guidance regarding optimal treatment plans so that Allina caregivers can positively impact patients' QOL.
Read the detailed description
Quality measures, including quality of life (QOL), have become an increasingly important area of interest for health systems across the country. Systematic approaches to collect patient QOL data are needed to properly understand and act on this information. At Allina Health, the process of systematically collecting this information began in July, 2012. The information is not only collected by providers, but used to enhance the patient experience and provide patients with an active voice in their care. By considering QOL as another vital sign, Allina caregivers have an instantaneous understanding of the patient's health status and can utilize the data in real time. Additionally, by collecting this information at each visit, providers also have a longitudinal perspective of the patient's QOL and the health of the population of individuals under their care. Consequently, they can provide patients with resources and support that can have a positive impact on their health and well-being.
The purpose of this retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on QOL scores. The results will provide insight into QOL trends within different patient populations and provide guidance regarding optimal treatment plans so that Allina caregivers can positively impact patients' QOL.
- Conditions
- Medical Oncology, Cardiology, Integrative Medicine, Physical and Rehabilitation Medicine, Orthopedics, Spine
- Being tested
- PROMIS-10 questionnaire
- Keywords
- Quality of Life, Patient-Centered Care, Patient Outcome Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS-10 questionnaireOther
Patient completed a PROMIS-10 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Allina health patients | Not described Receives: Other: PROMIS-10 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate average baseline QOL scores by clinical population, demographic group, and across all of Allina Health.
Measured: July, 2012- December, 2014
Secondary outcomes (2)
To analyze the change in QOL scores over time by clinical population and demographic group and across Allina Health.
Measured: July, 2012- December, 2014
To study the effect of programmatic clinical interventions on QOL scores by population.
Measured: July, 2012- December, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startJul 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medical OncologyStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 43,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906423
- Sponsor's protocol ID
- 2015011
- Status last verified
- Jan 2017
- First submitted
- 15 Sep 2016
- Last updated
- 11 Jan 2017
- Results posted
- No
Publications
Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
PubMed 23381511Wolever RQ, Abrams DI, Kligler B, Dusek JA, Roberts R, Frye J, Edman JS, Amoils S, Pradhan E, Spar M, Gaudet T, Guarneri E, Homel P, Amoils S, Lee RA, Berman B, Monti DA, Dolor R. Patients seek integrative medicine for preventive approach to optimize health. Explore (NY). 2012 Nov-Dec;8(6):348-52. doi: 10.1016/j.explore.2012.08.005.
PubMed 23141791Howie L, Hirsch B, Locklear T, Abernethy AP. Assessing the value of patient-generated data to comparative effectiveness research. Health Aff (Millwood). 2014 Jul;33(7):1220-8. doi: 10.1377/hlthaff.2014.0225.
PubMed 25006149Glasgow RE, Kaplan RM, Ockene JK, Fisher EB, Emmons KM. Patient-reported measures of psychosocial issues and health behavior should be added to electronic health records. Health Aff (Millwood). 2012 Mar;31(3):497-504. doi: 10.1377/hlthaff.2010.1295.
PubMed 22392660
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results From a Health System-wide Implementation of a Quality of Life Questionnaire
- ClinicalTrials.gov ID
- NCT02906423
- Acronym / sponsor ID
- 2015011
- Conditions
- Medical Oncology, Cardiology, Integrative Medicine, Physical and Rehabilitation Medicine, Orthopedics, Spine
- Keywords
- Quality of Life, Patient-Centered Care, Patient Outcome Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43,000 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Sep 2016 (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 retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on QOL scores. The results will provide insight into QOL trends within different patient populations and provide guidance regarding optimal treatment plans so that Allina caregivers can positively impact patients' QOL.
Detailed description
Quality measures, including quality of life (QOL), have become an increasingly important area of interest for health systems across the country. Systematic approaches to collect patient QOL data are needed to properly understand and act on this information. At Allina Health, the process of systematically collecting this information began in July, 2012. The information is not only collected by providers, but used to enhance the patient experience and provide patients with an active voice in their care. By considering QOL as another vital sign, Allina caregivers have an instantaneous understanding of the patient's health status and can utilize the data in real time. Additionally, by collecting this information at each visit, providers also have a longitudinal perspective of the patient's QOL and the health of the population of individuals under their care. Consequently, they can provide patients with resources and support that can have a positive impact on their health and well-being.
The purpose of this retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on QOL scores. The results will provide insight into QOL trends within different patient populations and provide guidance regarding optimal treatment plans so that Allina caregivers can positively impact patients' QOL.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allina health patients | – | Other: PROMIS-10 questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a retrospective chart review of up to 75,000 patients seen at an Allina Health facility who completed a Patient Reported Outcomes Measurement Information System Global Short Form (PROMIS-10) questionnaire between July 1, 2012 and December 31, 2016. Service line programs in which this questionnaire was deployed included the following: cardiac rehabilitation, heart failure, care management, physical and mental rehabilitation, integrative medicine, oncology, orthopedic, palliative care, pulmonary rehabilitation, primary care, and spine. Patients over 17 years of age who completed a PROMIS-10 questionnaire in an Allina Health clinic between July 1, 2012 and December 31, 2016 will be included in the study.
Key inclusion criteria (1 listed)
- patients seen at an Allina Health outpatient facility who complete a PROMIS-10 questionnaire between July 1, 2012 and December 31, 2016.
Key exclusion criteria (1 listed)
- patients who did not allow their records to be used for research purposes are not included in the study
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 |
|---|---|---|
| PROMIS-10 questionnairePatient completed a PROMIS-10 questionnaire | Other | Allina health patients |
Primary outcome
To investigate average baseline QOL scores by clinical population, demographic group, and across all of Allina Health.
Time frame: July, 2012- December, 2014
2 secondary outcomes
To analyze the change in QOL scores over time by clinical population and demographic group and across Allina Health.
Time frame: July, 2012- December, 2014
To study the effect of programmatic clinical interventions on QOL scores by population.
Time frame: July, 2012- December, 2014
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 11 Jan 2017.
- Background: PubMed 23381511Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
- Background: PubMed 23141791Wolever RQ, Abrams DI, Kligler B, Dusek JA, Roberts R, Frye J, Edman JS, Amoils S, Pradhan E, Spar M, Gaudet T, Guarneri E, Homel P, Amoils S, Lee RA, Berman B, Monti DA, Dolor R. Patients seek integrative medicine for preventive approach to optimize health. Explore (NY). 2012 Nov-Dec;8(6):348-52. doi: 10.1016/j.explore.2012.08.005.
- Background: PubMed 25006149Howie L, Hirsch B, Locklear T, Abernethy AP. Assessing the value of patient-generated data to comparative effectiveness research. Health Aff (Millwood). 2014 Jul;33(7):1220-8. doi: 10.1377/hlthaff.2014.0225.
- Background: PubMed 22392660Glasgow RE, Kaplan RM, Ockene JK, Fisher EB, Emmons KM. Patient-reported measures of psychosocial issues and health behavior should be added to electronic health records. Health Aff (Millwood). 2012 Mar;31(3):497-504. doi: 10.1377/hlthaff.2010.1295.
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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?
An observational study of Medical Oncology and Cardiology, run by Allina Health System 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 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 11 Jan 2017. 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?
To investigate average baseline QOL scores by clinical population, demographic group, and across all of Allina Health. (time frame: July, 2012- December, 2014). 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 NCT02906423, which also lists 4 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 11 Jan 2017.