Skip to main content
OpenTrials
Completed

NCT Number: NCT01347619

iADAPT: Off Label Use of Antipsychotics in the Nursing Home

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Off-label Use of Atypical Antipsychotic Drugs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qualidigm

Rocky Hill, Connecticut, 06067, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toolkit only with Web Access to Online Version

Other

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.

Toolkit, Periodic Audit/Feedback, Educational Messages

Other

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.

Items in Arm 2 plus Academic Detailing Program

Other

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.

Primary outcomes

  1. Aim 1 NEEDS ASSESSMENT - to describe interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG

    Time frame: months 4-8

    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

  2. Aim 1 NEEDS ASSESSMENT - to describe the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs

    Time frame: months 4-8

    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.

  3. Aim 1 NEEDS ASSESSMENT - to describe approaches to integrating comparative effectiveness research products into the NH setting

    Time frame: months 4-8

    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.

  4. 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

    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.

  5. Aim 3 - To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial

    Time frame: months 31-36

    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).

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Omnicare Clinical Research
  • Qualidigm

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 4, 2011
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.