All Causes Hospital AdmissionsROADMAPNCT02684188
Rural Options At Discharge Model of Active Planning
A study testing Enhanced rural discharge and transition in people with All Causes Hospital Admissions, run by University of Montana.
Trial summary
Residents of rural and frontier counties experience significant disparities in health care access and outcomes when compared to their urban counterparts. The organization of health care delivery contributes significantly to these disparities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- All Causes Hospital Admissions
- What is being tested?
- Enhanced rural discharge and transition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 31 Jan 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 75 years of age
- Admitted to St. Patrick regional referral hospital for treatment
- Discharged home to one of four rural counties in Montana
Who cannot join
- Primary diagnosis involves psychiatric condition or substance abuse
- Inmates of state prison
- Admitted under ongoing criminal investigation.
About this study
Residents of rural and frontier counties experience significant disparities in health care access and outcomes when compared to their urban counterparts. The organization of health care delivery contributes significantly to these disparities. For rural residents with multiple chronic conditions, transitioning along the continuum of care, between systems of treatment and support, and between dispersed locations present significant challenges. One critical challenge involves hospitalization for treatment because it requires travel to locations at a significant distance from home and disrupts personal and family routines. The transition back home is also problematic because discharge planning does not adequately account for limited access to care in rural areas. Indeed, discharge planning has been recently described as a "black hole;" fragmented and uncoordinated, and contributing to poor outcomes and patient dissatisfaction. The specific aim of this research is to ascertain rural patients' actual experience of the discharge planning process and to involve patients and rural providers in designing and testing a contextually appropriate rural options discharge model (ROADMAP) that improves patient outcomes and reduces re-hospitalizations.
Read the detailed description
Residents of rural counties experience significant disparities in health care access and outcomes when compared to their urban counterparts. These disparities are structural; based in our market-based medical care delivery system. For rural residents with multiple chronic conditions, transitioning along the continuum of care, between systems of treatment and support, and between dispersed locations both expose and produce disparities. The transition home from hospitalization for treatment exposes the current urban bias. Indeed, discharge planning is fragmented and uncoordinated, and contributes to poor the disparities. The specific aims of this research is to ascertain rural patients' actual experience of discharge; then to involve patients and rural providers in using those data to design a contextually appropriate rural options at discharge model of active planning (ROADMAP) that improves patient outcomes and reduces disparities. Objectives include:
- Ascertain actual patient experience in the rural discharge process.
- Design the ROADMAP model to fit the emerging health services context.
- Test the ROADMAP's efficacy in enhancing patient defined outcomes.
- Design the components for rapid diffusion.
Researchers will work in four counties of the Missoula Hospital Referral Region with a total population of 53,116 living on 12,342 square miles (4.3 persons per square mile). Researchers will recruit patients seeking treatment from St. Patrick Hospital. Patients and patient advocates will serve on an Innovations Design Team (IDT) to create the ROADMAP. Researchers will first interview patients (n = 40) who have been discharged to one of the rural counties. Researchers will compare their experiences to guidelines. Next, they will conduct a Design Survey (n=600) to verify goals important to patients. The IDT will use these findings to develop design requirements for ROADMAP. Finally, we will use a quasi-experimental research design to compare the patient designed rural ROADMAP to standard practice. The primary outcome measures are measures that reflect the patient's values for health-related quality of life and functional status, as well as hospital re-admissions. An independent statistician will use Hierarchical Linear Modeling to examine the complex relationships. This approach accounts for patients nested in four counties and the correlated errors inherent in within subject analysis. Health care reform sets the occasion for rapid diffusion of ROADMAP. This can provide an incremental reduction in rural disparities. Incorporating patient and provider input increases the likelihood it will fit within the emerging reimbursement model. Researchers expect that ROADMAP will reduce re-hospitalizations by as much as 30%, and improve patient recovery and return to participation in daily life.
- Conditions
- All Causes Hospital Admissions
- Being tested
- Enhanced rural discharge and transition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced rural discharge and transitionBehavioural
While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Standard hospital discharge services | No intervention | Patients received standard discharge planning; the baseline and return to baseline groups were combined to form a single standard discharge group |
| Enhanced rural discharge and transition | Experimental | Enhanced rural discharge and transition involved conducting a functional needs assessment before discharge. Identified needs were shared with a Local Community Transition Coordinator (LCTC). Needs include such patient centered issues as housing, transportation, emotional support, support for completing daily chores, and assistance in securing local follow-up appointments. Once a patient returned home, the LCTC conduct a review of discharge orders to insure a patient can meet those recommendations. Then the LCTC worked with the patient to develop and implement a transition plan that linked the patient to local resources he or she can use to address needs. The LCTC also provided direct supports. This plan was implemented over the course of the first 30 days after discharge. Receives: Behavioral: Enhanced rural discharge and transition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Re-admissions Analyzed by Poisson Regression
Number of admissions to any hospital reported by the patients after discharge from a regional hospital to one of four rural counties.
Measured: 3, 7 ,14, 21, 30, 60, and 90 days after discharge
Hospital Re-admissions Analyzed by Logistic Regression
Proportion of patients who self-report at least one hospital readmission to any hospital after discharge from a regional hospital to one of four rural counties.
Measured: 3, 7 ,14, 21, 30, 60, and 90 days after discharge
Emergency Department (ED) Visits Analyzed by Poisson Regression
Number of self-reported visits to the emergency department of any hospital reported by patients after discharge from a regional hospital to one of four rural counties.
Measured: 3, 7, 14, 21,30, 60, and 90 days after discharge
Emergency Department (D) Visits Analyzed by Logistic Regression
Proportion of patients who report at least one emergency department visit after discharge from a regional hospital to one of four rural counties.
Measured: 3, 7, 14, 21,30, 60, and 90 days after discharge
Primary Care Provider (PCP) Visits Analyzed by Poisson Regression
This reflects the number of visits to a patient's local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.
Measured: 3, 7, 14, 21, 30, 60, and 90 days after discharge
Primary Care Provider (PCP) Visits Analyzed by Logistic Regression
This reflects the proportion of patients who reported at least one visit to a their local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.
Measured: 3, 7, 14, 21, 30, 60, and 90 days after discharge
Secondary outcomes (4)
Short Form (SF12) Physical Health Score
The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health. Patients rate each item on an ordinal scale. Data are analyzed using a proprietary algorithm. Scores range from 0 to 100. Higher scores reflect a better health status. The analysis creates an overall health score and sub scores that reflect physical health and mental health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.
Measured: 3, 7, 14, 21, 30, 60, and 90 days after discharge
Short Form (SF12) Mental Health Score
The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health. Patients rate each item on an ordinal scale. Data are analyzed using a proprietary algorithm. Scores range from 0 to 100. Higher scores reflect a better health status. The analysis creates an overall health score and sub scores that reflect physical health and mental health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.
Measured: 3, 7, 14, 21, 30, 60, and 90 days after discharge
Care Transition Measure (CTM3)
The CTM3 is a three-item standardized questionnaire to measures patients' perspectives on coordination of hospital discharge care. Patients rate whether they strongly agree, agree, disagree, or strongly disagree with three items (hospital staff too my preferences into account, I had a good idea what I was responsible for once I left the hospital, and I clearly understood the purpose for taking each of my medications). They may also rate an items as not applicable to their situation. Ratings are converted to a scale that ranges from 0 to 100. Higher scores reflect better discharge care.
Measured: 3 days after discharge
Rural Transition Measure (RTM14)
The RTM14 is a fourteen-item questionnaire to measures patients' perspectives on the delivery of transition services and supports after discharge from a regional hospital to a small town or rural community. Patients respond by indicating whether they strongly disagree, disagree, agree, or strongly agree with each of the 14 items. Patients may also indicate whether an item is not applicable to their situation. Ratings are converted to a scale that ranges from 0 to 100. Higher scores reflect better transition service performance.
Measured: 7, 14, 21, 30, 60, and 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startOct 2015
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for All Causes Hospital AdmissionsStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients were recruited from those admitted from one of four rural counties. In the initial phase, all patients enrolled from any county were assigned to a baseline condition. After enrollment stabilized, patients from one county were enrolled in the intervention while patients from the other three counties remained in baseline. Subsequently the intervention was introduced to the other counties sequentially while others remained in baseline. A return to baseline conditions followed a period after the intervention had been introduced in all counties.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- Providence St. Patrick Hospital, Missoula Montana
- Responsible party
- Principal investigator, Tom Seekins, University of Montana
- Investigators
- Tom W Seekins, Ph.D., Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684188
- Sponsor's protocol ID
- 177-15
- Acronym
- ROADMAP
- Status last verified
- Oct 2017
- First submitted
- 30 Dec 2015
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Options At Discharge Model of Active Planning
- ClinicalTrials.gov ID
- NCT02684188
- Acronym / sponsor ID
- ROADMAP / 177-15
- Conditions
- All Causes Hospital Admissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- Providence St. Patrick Hospital, Missoula Montana
- Study start
- Oct 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Residents of rural and frontier counties experience significant disparities in health care access and outcomes when compared to their urban counterparts. The organization of health care delivery contributes significantly to these disparities. For rural residents with multiple chronic conditions, transitioning along the continuum of care, between systems of treatment and support, and between dispersed locations present significant challenges. One critical challenge involves hospitalization for treatment because it requires travel to locations at a significant distance from home and disrupts personal and family routines. The transition back home is also problematic because discharge planning does not adequately account for limited access to care in rural areas. Indeed, discharge planning has been recently described as a "black hole;" fragmented and uncoordinated, and contributing to poor outcomes and patient dissatisfaction. The specific aim of this research is to ascertain rural patients' actual experience of the discharge planning process and to involve patients and rural providers in designing and testing a contextually appropriate rural options discharge model (ROADMAP) that improves patient outcomes and reduces re-hospitalizations.
Detailed description
Residents of rural counties experience significant disparities in health care access and outcomes when compared to their urban counterparts. These disparities are structural; based in our market-based medical care delivery system. For rural residents with multiple chronic conditions, transitioning along the continuum of care, between systems of treatment and support, and between dispersed locations both expose and produce disparities. The transition home from hospitalization for treatment exposes the current urban bias. Indeed, discharge planning is fragmented and uncoordinated, and contributes to poor the disparities. The specific aims of this research is to ascertain rural patients' actual experience of discharge; then to involve patients and rural providers in using those data to design a contextually appropriate rural options at discharge model of active planning (ROADMAP) that improves patient outcomes and reduces disparities. Objectives include:
- Ascertain actual patient experience in the rural discharge process.
- Design the ROADMAP model to fit the emerging health services context.
- Test the ROADMAP's efficacy in enhancing patient defined outcomes.
- Design the components for rapid diffusion.
Researchers will work in four counties of the Missoula Hospital Referral Region with a total population of 53,116 living on 12,342 square miles (4.3 persons per square mile). Researchers will recruit patients seeking treatment from St. Patrick Hospital. Patients and patient advocates will serve on an Innovations Design Team (IDT) to create the ROADMAP. Researchers will first interview patients (n = 40) who have been discharged to one of the rural counties. Researchers will compare their experiences to guidelines. Next, they will conduct a Design Survey (n=600) to verify goals important to patients. The IDT will use these findings to develop design requirements for ROADMAP. Finally, we will use a quasi-experimental research design to compare the patient designed rural ROADMAP to standard practice. The primary outcome measures are measures that reflect the patient's values for health-related quality of life and functional status, as well as hospital re-admissions. An independent statistician will use Hierarchical Linear Modeling to examine the complex relationships. This approach accounts for patients nested in four counties and the correlated errors inherent in within subject analysis. Health care reform sets the occasion for rapid diffusion of ROADMAP. This can provide an incremental reduction in rural disparities. Incorporating patient and provider input increases the likelihood it will fit within the emerging reimbursement model. Researchers expect that ROADMAP will reduce re-hospitalizations by as much as 30%, and improve patient recovery and return to participation in daily life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were recruited from those admitted from one of four rural counties. In the initial phase, all patients enrolled from any county were assigned to a baseline condition. After enrollment stabilized, patients from one county were enrolled in the intervention while patients from the other three counties remained in baseline. Subsequently the intervention was introduced to the other counties sequentially while others remained in baseline. A return to baseline conditions followed a period after the intervention had been introduced in all counties.
| Arm | Type | Receives |
|---|---|---|
| Standard hospital discharge services | No intervention | –Patients received standard discharge planning; the baseline and return to baseline groups were combined to form a single standard discharge group |
| Enhanced rural discharge and transition | Experimental | Behavioral: Enhanced rural discharge and transitionEnhanced rural discharge and transition involved conducting a functional needs assessment before discharge. Identified needs were shared with a Local Community Transition Coordinator (LCTC). Needs include such patient centered issues as housing, transportation, emotional support, support for completing daily chores, and assistance in securing local follow-up appointments. Once a patient returned home, the LCTC conduct a review of discharge orders to insure a patient can meet those recommendations. Then the LCTC worked with the patient to develop and implement a transition plan that linked the patient to local resources he or she can use to address needs. The LCTC also provided direct supports. This plan was implemented over the course of the first 30 days after discharge. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18 and 75 years of age
- Admitted to St. Patrick regional referral hospital for treatment
- Discharged home to one of four rural counties in Montana
Key exclusion criteria (3 listed)
- Primary diagnosis involves psychiatric condition or substance abuse
- Inmates of state prison
- Admitted under ongoing criminal investigation.
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 |
|---|---|---|
| Enhanced rural discharge and transitionWhile in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient. | Behavioural | Enhanced rural discharge and transition |
Primary outcome
Hospital Re-admissions Analyzed by Poisson Regression
Time frame: 3, 7 ,14, 21, 30, 60, and 90 days after discharge
Number of admissions to any hospital reported by the patients after discharge from a regional hospital to one of four rural counties.
Hospital Re-admissions Analyzed by Logistic Regression
Time frame: 3, 7 ,14, 21, 30, 60, and 90 days after discharge
Proportion of patients who self-report at least one hospital readmission to any hospital after discharge from a regional hospital to one of four rural counties.
Emergency Department (ED) Visits Analyzed by Poisson Regression
Time frame: 3, 7, 14, 21,30, 60, and 90 days after discharge
Number of self-reported visits to the emergency department of any hospital reported by patients after discharge from a regional hospital to one of four rural counties.
Emergency Department (D) Visits Analyzed by Logistic Regression
Time frame: 3, 7, 14, 21,30, 60, and 90 days after discharge
Proportion of patients who report at least one emergency department visit after discharge from a regional hospital to one of four rural counties.
Primary Care Provider (PCP) Visits Analyzed by Poisson Regression
Time frame: 3, 7, 14, 21, 30, 60, and 90 days after discharge
This reflects the number of visits to a patient's local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.
Primary Care Provider (PCP) Visits Analyzed by Logistic Regression
Time frame: 3, 7, 14, 21, 30, 60, and 90 days after discharge
This reflects the proportion of patients who reported at least one visit to a their local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.
4 secondary outcomes
Short Form (SF12) Physical Health Score
Time frame: 3, 7, 14, 21, 30, 60, and 90 days after discharge
Short Form (SF12) Mental Health Score
Time frame: 3, 7, 14, 21, 30, 60, and 90 days after discharge
Care Transition Measure (CTM3)
Time frame: 3 days after discharge
Rural Transition Measure (RTM14)
Time frame: 7, 14, 21, 30, 60, and 90 days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tom W Seekins, Ph.D. principal investigator
University of Montana
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced rural discharge and transition in people with All Causes Hospital Admissions, run by University of Montana.
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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 20 Nov 2017). 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?
Hospital Re-admissions Analyzed by Poisson Regression (time frame: 3, 7 ,14, 21, 30, 60, and 90 days after discharge). The study lists 6 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 20 Nov 2017.