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Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions

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ClinicalTrials.gov Identifier: NCT02059005
Recruitment Status : Completed
First Posted : February 11, 2014
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Treatment Research Institute

Brief Summary:
This study will assess Specialized Community Disease Management (SCDM), an intervention which employs various evidence-based strategies to engage substance using co-morbid patients while in the hospital and follow them into the community via an empirically validated telephone approach as well as contact with a trained community health worker peer specialist. The investigators will first adapt and refine the core SCDM intervention with patient, provider, and stakeholder input through an active community advisory board. The investigators will then conduct a three-year, randomized controlled trial of 222 patients enrolled prior to hospital discharge who are diagnosed with congestive heart failure, pneumonia, acute myocardial infarction, chronic obstructive pulmonary disease, diabetes mellitus, or end-stage renal disease, and a substance use disorder (SUD). Patients will be randomized to either the SCDM intervention or Treatment as Usual (TAU), in which a team of nurse navigators and community health workers follow patients (primarily by telephone) for 90 days post-discharge, but do not address the specific needs of SUDs. The investigators will test the following four hypotheses: (1) patients randomized to SCDM will demonstrate larger reductions in substance use measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty substance abuse intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of rehospitalization and use of acute emergency services than patients randomized to TAU.

Condition or disease Intervention/treatment Phase
Drug Use Alcohol Use Congestive Heart Failure Pneumonia Acute Myocardial Infarction Diabetes Mellitus Chronic Obstructive Pulmonary Disease End-Stage Renal Disease Behavioral: Specialized Community Disease Management Behavioral: Treatment As Usual Not Applicable

Detailed Description:
Hospitalized patients with substance use disorders (SUDs) face significant complications in their medical care. They are more likely to be discharged against medical advice, rehospitalized after discharge, and experience personal chaos and reduced family support. Hospital systems are moving to implement hospital-based and community disease management strategies to help patients transition post-discharge, however, few provide specialized follow-up for patients with SUDs. This proposal will test whether an extended, specialized community disease management program can improve outcomes over an existing nurse navigator disease management strategy for patients with co-morbid medical conditions and SUDs. The investigators will enroll 222 inpatients with co-occurring medical conditions and SUDs and will randomly assign them to either 1) Treatment as Usual - a 90-day, post-discharge program that consists of medical monitoring by workers who have no special training in working with SUD patients, or 2) the Specialized Community Disease Management program - a 90-day program that will employ specialized teams including a trained clinical social worker and a peer-specialist community health worker who will provide evidence-based telephone continuing care, home visits, and increased focus on patients' substance use. All participants will be followed at 3- and 6-months post-discharge. The investigators hypothesize that (1) patients randomized to SCDM will demonstrate larger reductions in substance use measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty substance abuse intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of rehospitalization and use of acute emergency services than patients randomized to TAU.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Actual Study Start Date : November 18, 2014
Actual Primary Completion Date : February 16, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Specialized Community Disease Management
Specialized Community Disease Management
Behavioral: Specialized Community Disease Management
Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.

Active Comparator: Treatment As Usual
Treatment as Usual: standard post-hospital discharge with medical monitoring.
Behavioral: Treatment As Usual
Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.




Primary Outcome Measures :
  1. Change in Substance Use Rates From Baseline [ Time Frame: 0, 3, 6 months ]
    Urinalysis confirmed self-reported days of use for any substance, including alcohol, cocaine, marijuana, opiates, sedatives, and hallucinogens over time. Participants reported substance use for the 90 days prior to the assessment date.


Secondary Outcome Measures :
  1. Change in Treatment Session Attendance From Baseline [ Time Frame: 0, 3, 6, months ]
    Treatment sessions attended for alcohol or drug use issues over time. Participants self-reported attendance for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported attendance since the last assessment date.

  2. Number of Hospitalizations and Use of Emergency Services [ Time Frame: 0, 3, 6, months ]
    Days of hospitalization and days of use of acute emergency services after Baseline. Participants self-reported their service utilization for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported their service utilization since the last assessment date.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient is 18 years or older
  • alcohol and/or drug screening score that indicates at least mild problem severity

Exclusion Criteria:

  • medical or psychiatric complications
  • patient was admitted to hospital directly from a drug and alcohol inpatient rehabilitation facility
  • patient reports plans to leave the area within the next 12 months
  • patient is unable to provide valid informed consent
  • patient is attending dialysis
  • patient is not English-speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059005


Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Treatment Research Institute
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Adam C Brooks, PhD Treatment Research Institute
  Study Documents (Full-Text)

Documents provided by Treatment Research Institute:
Study Protocol  [PDF] March 4, 2016
Statistical Analysis Plan  [PDF] June 30, 2017
Informed Consent Form  [PDF] June 7, 2016

Additional Information:
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Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT02059005    
Other Study ID Numbers: PCORI-1306-03482
First Posted: February 11, 2014    Key Record Dates
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: in line with HIPAA protections, we will make our final dataset available to other researchers. Fully de-identified data will be available to any researcher. If a researcher should request a limited dataset then we will only share that data after obtaining an appropriate data use agreement which includes an agreement not to attempt to re-identify or contact participants. We will not share directly identifiable data with outside researchers per our HIPAA authorization for this study.
Keywords provided by Treatment Research Institute:
Addiction
Substance Use Disorder
Rehospitalization
Community Disease Management
Behavioral Health
Community Health Worker
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pneumonia
Kidney Failure, Chronic
Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Respiratory Tract Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency