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HospitalizationNCT00462059

Assessment of a Medication Reconciliation Program on Transitional Care

A study testing Treatment in people with Hospitalization, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess and compare the effectiveness of the Kaiser Permanente Colorado's (KPCO) Call Center's Medication Reconciliation Program and standard care in regards to their impacts on emergency department (ED) and urgent care visits, inpatient rehospitalizations, and adherence to preferred… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hospitalization
What is being tested?
Treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Jun 2005to Mar 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • KPCO members discharged on medications from either the Good Samaritan or St. Joseph hospitals

Who cannot join

  • Discharged from the IP to a hospice or long term care or skilled nursing facility, less than 18 years of age, discharged from a hospital other than Good Samaritan or St. Joseph, or enrolled in another trial that is identified in Health Connect EMR

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kaiser-Permanente Colorado Region, Clinical Pharmacy Dept.

    Aurora, Colorado, 80011

Other trials in United States

About this study

Official title: Impact of a Medication Reconciliation Program on Patients Transitioning From an Inpatient Hospitalization to Primary Care

The purpose of this study is to assess and compare the effectiveness of the Kaiser Permanente Colorado's (KPCO) Call Center's Medication Reconciliation Program and standard care in regards to their impacts on emergency department (ED) and urgent care visits, inpatient rehospitalizations, and adherence to preferred, formulary medications.

Read the detailed description

This study will be a health services evaluation. This study will be a pilot study utilizing a randomized controlled trial design. This study will utilize secondary data collected from existing KPCO databases to assess outcomes. Interventions will occur over a one-month period. The study will take approximately twelve months to conduct including the data collection and analysis, results interpretation, and manuscript and report preparation. The duration of intervention group subject participation will be limited to the length of the medication reconciliation counseling phone call and the 3-month follow-up period while the duration of control group subject participation will be limited to the 3-month follow-up period.

KPCO internists discharging patients on medications to ambulatory care from either the Good Samaritan or St. Joseph hospitals over a four-week period will send discharge orders to the CPCC via Health Connect. Project-dedicated CPCC pharmacists will utilize the inclusion and exclusion criteria to determine patient eligibility. Project-dedicated CPCC staff will make several attempts at varying times during the 24 hours following reception of the discharge note in Health Connect to conduct the telephonic consent process among eligible patients. If a patient can not be contacted after several attempts, the staff member will leave a HIPAA-compliant message, if possible, to request either the patient or his/her caregiver call the CPCC. If the subject doesn't not contact the CPCC after being left such a message, the staff member will make two attempts the following day to contact the subject and/or his/her caregiver. Patients consenting to participate will be categorized by hospital and, based on category, randomly assigned to the intervention or control group. Project-dedicated pharmacists will review intervention group subjects' discharge medication orders, identify discrepancies between their primary care regimen and the hospital discharge orders, and collaborate with the patient's primary care physician or discharging provider to reconcile any discrepancies. Project-dedicated pharmacists will make several telephonic attempts at varying times during the 24 hours post-assignment to contact an intervention group subject and/or his/her caregiver to execute the medication review counseling after performing the medication review. If the subject can not be contacted after several attempts, the pharmacist will leave a HIPAA-compliant message, if possible, to request either the subject or his/her caregiver call the CPCC. If the subject doesn't not contact the CPCC in the day after being left such a message, the pharmacist will make two attempts per day for two more days to contact the subject and/or his/her caregiver. Assignment dates will be used as an index dates from which rolling baseline and follow-up periods will be determined.

Data will be analyzed on an intention-to-treat basis. Baseline subject characteristics and study outcomes for each of the cohorts will be reported as means, medians, and standard deviations for interval- and ratio-level variables (e.g., age) and proportions for nominal- and ordinal-level data (e.g., gender, hospital discharge diagnoses, post-discharge ED and urgent care visits, IP readmission). Interval-and ratio-level variables will be assessed for normality of their distributions. Appropriate parametric (e.g., independent samples t-test) or non-parametric (e.g., Wilcoxon rank-sum test) statistical tests will then be performed to assess differences in mean or median values. Ordinal-level and nominal-level will be assessed with the Pearson's chi-square statistical test. Logistic regression modeling will be used to assess the relationships between the group and binary data (e.g., ED and urgent care visits, receiving a non-preferred formulary agent) while adjusting for potential confounders (e.g., age, hospital discharge diagnosis, gender, CDS).

Conditions
Hospitalization
Being tested
Treatment
Keywords
Transition of care, Continuity of care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TreatmentBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of emergency room visits post-discharge

  2. Number of urgent care visits post-discharge

  3. Number of inpatient rehospitalizations

  4. Adherence to preferred, formulary medications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2007 (estimated)
  2. Study startJun 2005
  3. Study completionMar 2007

Resources

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
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462059
Sponsor's protocol ID
CO-05TDela-02
Status last verified
Apr 2007
First submitted
16 Apr 2007
Last updated
18 Apr 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Treatment in people with Hospitalization, run by Kaiser Permanente 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 18 Apr 2007. 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?

Number of emergency room visits post-discharge. The study lists 4 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 18 Apr 2007.

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