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iADAPT: Off Label Use of Antipsychotics in the Nursing Home

This study has been completed.
Sponsor:
Collaborators:
Qualidigm
Omnicare Clinical Research
Information provided by (Responsible Party):
Jerry Gurwitz, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01347619
First received: May 2, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The investigators propose to evaluate the effectiveness of 3 different methods to promote the dissemination and adoption of evidenced-based review guides into the nursing home setting. Specifically, the investigators will adapt Comparative Effectiveness Research (CER) Review products developed by the Agency for Healthcare Research and Quality (AHRQ), specifically related to off-label use of atypical antipsychotic drugs, to improve their penetration into practice in the nursing home (NH) setting.

The investigators propose the following specific aims:

AIM 1: NEEDS ASSESSMENT To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG in the NH setting; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting.

AIM 2: PRODUCTION OF THE TOOLKIT Guided by the needs assessment, the investigators will produce a toolkit containing tailored CERSG-based products targeting key audiences and stakeholders in the NH setting. The target audience(s) of the final CERSG-based products will be identified in Aim 1, and will potentially include: (a) facility leadership [NH administrator, Medical Director, Director of Nursing]; (b) prescribers and consultant pharmacists; (c) nursing staff [registered nurses, licensed practical nurses, and certified nurse assistants].

AIM 3: EVALUATING THE EFFECTIVENESS OF THE TOOLKIT To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial. NHs in the first arm will receive the toolkit only and web access to the materials; NHs in the second arm will receive the toolkit, web access, periodic audit and feedback reports of antipsychotic prescribing to NH leadership, and faxed educational messages adapted from the AHRQ atypical antipsychotic CERSG to prescribers; and NHs in the third arm will receive the previous items plus face-to-face academic detailing. Primary outcomes of the evaluation are the RE-AIM evaluation domains (reach, efficacy, adoption, implementation, and maintenance).The investigators will also include an assessment of facility-level changes in the use of atypical antipsychotic drugs.


Condition Intervention
Off-label Use of Atypical Antipsychotic Drugs
Other: Toolkit only with Web Access to Online Version
Other: Toolkit, Periodic Audit/Feedback, Educational Messages
Other: Items in Arm 2 plus Academic Detailing Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: iADAPT: Off Label Use of Antipsychotics in the Nursing Home

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Aim 1 NEEDS ASSESSMENT - to describe interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG [ Time Frame: months 4-8 ] [ Designated as safety issue: No ]
    Aim 1 - To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting

  • Aim 1 NEEDS ASSESSMENT - to describe the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs [ Time Frame: months 4-8 ] [ Designated as safety issue: No ]
    Aim 1 - To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting.

  • Aim 1 NEEDS ASSESSMENT - to describe approaches to integrating comparative effectiveness research products into the NH setting [ Time Frame: months 4-8 ] [ Designated as safety issue: No ]
    Aim 1 - To conduct a needs assessment for the NH setting relevant to the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled "Off-Label Use of Atypical Antipsychotic Drugs." The assessment will identify: (a) interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG; (b) the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to integrating comparative effectiveness research products into the NH setting.

  • Aim 2 - Guided by the needs assessment, we will produce a toolkit containing tailored CERSG-based products targeting key audiences and stakeholders in the NH setting. [ Time Frame: months 9-12 ] [ Designated as safety issue: No ]
    Aim 2 - Guided by the needs assessment, we will produce a toolkit containing tailored CERSG-based products targeting key audiences and stakeholders in the NH setting. The targets of the final CERSG-based products will be identified in Aim 1, and will potentially include: (a) facility leadership [NH administrator, Medical Director, Director of Nursing]; (b) prescribers and consultant pharmacists; (c) nursing staff [registered nurses, licensed practical nurses, and certified nurse assistants], and (d) residents and families.

  • Aim 3 - To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial [ Time Frame: months 31-36 ] [ Designated as safety issue: No ]
    Aim 3 - To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial. Primary outcomes of the evaluation are the RE-AIM evaluation domains (reach, efficacy, adoption, implementation, and maintenance).


Enrollment: 42
Study Start Date: November 2010
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1. Toolkit only with Web Access
NHs in this arm will receive the toolkit only and web access to the materials.
Other: Toolkit only with Web Access to Online Version
NHs in this arm will receive a letter announcing the availability of an atypical antipsychotic toolkit within the facility and online at the Qualidigm website. The letter will be sent to the NH administrator, Director of Nursing, and Medical Director of each facility by Qualidigm. It will state that the toolkit is designed to provide NH staff, including prescribers, leadership, nursing staff, and patients' families with information about the use, risks and costs of atypical antipsychotics in the NH setting.
Active Comparator: Arm 2.Toolkit, Audit/Feedback, Education
NHs in the second arm will receive the toolkit, web access, periodic audit and feedback reports of antipsychotic prescribing to NH leadership, and faxed educational messages adapted from the AHRQ atypical antipsychotic CERSG to prescribers.
Other: Toolkit, Periodic Audit/Feedback, Educational Messages
Providing healthcare professionals with data about their performance (audit and feedback) may help improve their practice. It is more effective when clinicians previously agree to review their practice. We will use an adaptation of a "Medicaid Utilization Report" developed by AM Hamer. This report will show current atypical antipsychotic prescribing rates in the NH, with comparisons to state and national levels, and information regarding summary evidence for atypical antipsychotics from the AHRQ atypical antipsychotic CERSG. Reports will be sent to the NH administrator, Director of Nursing, and Medical Director of the facilities randomized to the moderate intensity arm on an every 4-month basis.
Active Comparator: Arm 3. All above plus academic detailing
NHs in the third arm will receive the previous items plus face-to-face academic detailing.
Other: Items in Arm 2 plus Academic Detailing Program
This arm will receive the same information, toolkit, letters, and audit and feedback reports distributed to homes in the moderate-intensity arm. In addition, two visits to the NH will be scheduled by a pharmacist educator specially trained in the pharmacology of atypical antipsychotics, and communication techniques. Staff will be provided with up-to-date, unbiased information about antipsychotic use in NHs based on the AHRQ CER Review product adaptations. The educator will deliver targeted messages relevant to each stakeholder regarding roles in decision-making around the use atypical antipsychotic therapy in the NH setting. Each NH will receive up to two visits over the course of the 12-month intervention period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Qualidigm-affiliated Nursing Home facilities in Connecticut who agree to participate.

Participants in this study will include residents and employees of participating nursing homes or residents within these nursing homes. All members of this study population will be 18 years or older.

Exclusion Criteria:

  • Does not meet inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347619

Locations
United States, Connecticut
Qualidigm
Rocky Hill, Connecticut, United States, 06067
Sponsors and Collaborators
University of Massachusetts, Worcester
Qualidigm
Omnicare Clinical Research
Investigators
Principal Investigator: Jerry H Gurwitz, MD UMass Medical School
  More Information

Publications:
Responsible Party: Jerry Gurwitz, Executive Director, Meyers Primary Care Inst., University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01347619     History of Changes
Other Study ID Numbers: 13902
Study First Received: May 2, 2011
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Comparative Effectiveness Research Summary Guide (CERSG)
anti-psychotic use
Nursing Home
Long-term care
Qualitative assessment of influences on CERSG adoption in NH
Development of toolkit of CERSG-based products for NHs
Evaluation of 3 implementation strategies of the toolkit

Additional relevant MeSH terms:
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014