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Rural Options At Discharge Model of Active Planning (ROADMAP)

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ClinicalTrials.gov Identifier: NCT02684188
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
Providence St. Patrick Hospital, Missoula Montana
Information provided by (Responsible Party):
Tom Seekins, University of Montana

Tracking Information
First Submitted Date  ICMJE December 30, 2015
First Posted Date  ICMJE February 17, 2016
Results First Submitted Date  ICMJE July 31, 2017
Results First Posted Date  ICMJE November 20, 2017
Last Update Posted Date November 20, 2017
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Change over baseline in Re-hospitalizations [ Time Frame: Within the first 90 days post discharge ]
Number of admissions to any hospital following discharge
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • Short Form (SF12) Physical Health Score [ Time Frame: 3, 7, 14, 21, 30, 60, and 90 days after discharge ]
    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.
  • Short Form (SF12) Mental Health Score [ Time Frame: 3, 7, 14, 21, 30, 60, and 90 days after discharge ]
    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.
  • Care Transition Measure (CTM3) [ Time Frame: 3 days after discharge ]
    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.
  • Rural Transition Measure (RTM14) [ Time Frame: 7, 14, 21, 30, 60, and 90 days after discharge ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Change over baseline in Medical Outcomes Study Short Form 12 [ Time Frame: During the first 90 days post discharge ]
Self-reported physical, functional, and emotional health
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 11, 2016)
  • Change over baseline in Coleman Transitions Measure 3 [ Time Frame: 3 days after discharge ]
    A three item rating of the discharge services and supports received
  • Change over baseline in Rural Transitions Assessment 12 [ Time Frame: During the first 90 days post discharge ]
    A 12 item rating of the Rural Transitional services and supports received
 
Descriptive Information
Brief Title  ICMJE Rural Options At Discharge Model of Active Planning
Official Title  ICMJE Rural Options At Discharge Model of Active Planning
Brief 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. 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:

  1. Ascertain actual patient experience in the rural discharge process.
  2. Design the ROADMAP model to fit the emerging health services context.
  3. Test the ROADMAP's efficacy in enhancing patient defined outcomes.
  4. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE All Causes Hospital Admissions
Intervention  ICMJE Behavioral: Enhanced rural discharge and transition
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 Arms  ICMJE
  • No Intervention: Standard hospital discharge services
    Patients received standard discharge planning; the baseline and return to baseline groups were combined to form a single standard discharge group
  • Experimental: Enhanced rural discharge and transition
    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.
    Intervention: Behavioral: Enhanced rural discharge and transition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
127
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
145
Actual Study Completion Date  ICMJE January 31, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Primary diagnosis involves psychiatric condition or substance abuse
  • Inmates of state prison
  • Admitted under ongoing criminal investigation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02684188
Other Study ID Numbers  ICMJE 177-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tom Seekins, University of Montana
Study Sponsor  ICMJE University of Montana
Collaborators  ICMJE Providence St. Patrick Hospital, Missoula Montana
Investigators  ICMJE
Principal Investigator: Tom W Seekins, Ph.D. University of Montana
PRS Account University of Montana
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP