iADAPT: Off Label Use of Antipsychotics in the Nursing Home

University of Massachusetts, Worcester

Status: Completed

Conditions: Off-label Use of Atypical Antipsychotic Drugs

Treatments: Other: Items in Arm 2 plus Academic Detailing Program; Other: Toolkit only with Web Access to Online Version; Other: Toolkit, Periodic Audit/Feedback, Educational Messages

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT01347619

13902

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 3 patient groups

Arm 1. Toolkit only with Web Access

Active Comparator group

Description:

NHs in this arm will receive the toolkit only and web access to the materials.

Treatment:

Other: Toolkit only with Web Access to Online Version

Arm 2.Toolkit, Audit/Feedback, Education

Active Comparator group

Description:

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.

Treatment:

Other: Toolkit, Periodic Audit/Feedback, Educational Messages

Arm 3. All above plus academic detailing

Active Comparator group

Description:

NHs in the third arm will receive the previous items plus face-to-face academic detailing.

Treatment:

Other: Items in Arm 2 plus Academic Detailing Program