Clinical trial NCT01347619: iADAPT: Off Label Use of Antipsychotics in the Nursing Home
Official title: iADAPT: Off Label Use of Antipsychotics in the Nursing Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Off-label Use of Atypical Antipsychotic Drugs
Keywords: 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
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Qualidigm
name: Omnicare Clinical Research
First posted: 2011-05-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Aim 1 NEEDS ASSESSMENT - to describe interest in and barriers to the use of the AHRQ atypical antipsychotic CERSG
timeFrame: months 4-8
measure: Aim 1 NEEDS ASSESSMENT - to describe the key audiences and stakeholders that influence atypical antipsychotic drug use in NHs
timeFrame: months 4-8
measure: Aim 1 NEEDS ASSESSMENT - to describe approaches to integrating comparative effectiveness research products into the NH setting
timeFrame: months 4-8
measure: 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.
timeFrame: months 9-12
measure: Aim 3 - To evaluate the effectiveness of the toolkit and three dissemination strategies using a matched, cluster randomized trial
timeFrame: months 31-36
Secondary outcomes:
Other outcomes:
Locations:
city: Rocky Hill
country: United States
facility: Qualidigm
state: Connecticut
Study officials:
affiliation: UMass Medical School
name: Jerry H Gurwitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tjia J, Gurwitz JH, Briesacher BA. Challenge of changing nursing home prescribing culture. Am J Geriatr Pharmacother. 2012 Feb;10(1):37-46. doi: 10.1016/j.amjopharm.2011.12.005. Epub 2012 Jan 20.
citation: Lemay CA, Mazor KM, Field TS, Donovan J, Kanaan A, Briesacher BA, Foy S, Harrold LR, Gurwitz JH, Tjia J. Knowledge of and perceived need for evidence-based education about antipsychotic medications among nursing home leadership and staff. J Am Med Dir Assoc. 2013 Dec;14(12):895-900. doi: 10.1016/j.jamda.2013.08.009. Epub 2013 Sep 24.
citation: Briesacher BA, Tjia J, Field T, Peterson D, Gurwitz JH. Antipsychotic use among nursing home residents. JAMA. 2013 Feb 6;309(5):440-2. doi: 10.1001/jama.2012.211266. No abstract available.
citation: Tjia J, Field T, Lemay C, Mazor K, Pandolfi M, Spenard A, Ho SY, Kanaan A, Donovan J, Gurwitz JH, Briesacher B. Antipsychotic use in nursing homes varies by psychiatric consultant. Med Care. 2014 Mar;52(3):267-71. doi: 10.1097/MLR.0000000000000076.