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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01703689
Other study ID # ARSMP.2010.1
Secondary ID
Status Completed
Phase N/A
First received September 27, 2012
Last updated July 18, 2016
Start date May 2011
Est. completion date March 2013

Study information

Verified date July 2016
Source Agence Régionale de la Santé - Midi Pyrénées
Contact n/a
Is FDA regulated No
Health authority France: Ministry of HealthUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality indicators is not well-established.

The main objective: The main purpose of the IQUARE study was to examine the impact of two types of audit and feedback interventions on NH quality indicators and on residents dependence levels in a 18-month follow-up.

Study hypothesis: We hypothesised that audit and feedback associated to educational and professional supportive interventions are more efficacy in improving NH quality indicators than audit and feedback only.

Secondary objectives: Investigate the impact of the interventions on

1. Residents:

- Functional decline rate

- Drug prescriptions (quantity and quality)

- Prevalence of adverse health outcomes (e.g., falls)

2. NHs:

- Planning and implementation of therapeutic measures


Description:

IQUARE is a multicentric individually-tailored controlled trial comparing two types of audit and feedback interventions:

- audit and feedback associated to cooperative work meetings between hospital geriatricians and nursing home (NH) staff in a 6-month intervention (strong intervention)

- audit and feedback only (light intervention) Power statistics and sample size calculations indicated that each group should be composed of at least 2 500 individuals. The strong intervention will last 6 months and is composed of two face-to-face cooperative meetings (hospital geriatricians and NH staff). Data will be collected at baseline and in a 18-month follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 8039
Est. completion date March 2013
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Nursing homes (NH) voluntarily accepted to participate in the study.

- NH residents of both sex

- Residents living in the NH for = 30 days

- Residents and their general practitioner (GP) having received information about the study

- NH residents do not voluntarily decline to participate in the study

Exclusion Criteria:

- NH currently participating in another interventional study

- GP of NH residents refused participation in the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Audit and Feedback
Descriptive statistics to each nursing home (NH) with regards to its own indicators of quality and residents' health status, and the same descriptive statistics on the sub-regional and regional levels were done to all NHs for comparative purposes.
Cooperative Work
Nursing homes (NH)in the strong intervention group had two half-day meetings of cooperative work with a hospital geriatrician to identify NHs' weaknesses regarding quality of care and to establish strategies for overcoming these weaknesses.

Locations

Country Name City State
France EHPAD le parc ALBI Albi
France EHPAD Canarie Vieuzac Argelès-Gazost
France MAPAD Les Pradels Assier
France Les Jardins auscitains Auch
France Les jardins d´Agape Auch
France Saint Dominique Auch
France EHPAD Résidence Mutualiste La Pyrénéenne Aureilhan
France EHPAD Résidence Castelmouly Bagnères-de-Bigorre
France ONAC résidence paul oddo Barbazan
France Korian Les Ainés du Lauragais Baziège
France Notre Dame Beaumont-de-Lomagne
France Ehpad Sherpa Belmont-sur-Rance
France Le Pastel Bessières
France Le Pastourel Bessières
France Sainte-Cécile Bessières
France Emeraude Blagnac
France Résidence de Vinci Blagnac
France EHPAD St joseph de BRASSAC Brassac
France EHPAD Robert Durrieu Bretenoux
France M.R Orpea Cahors
France EHPAD La Cascade Cajarc
France Les Roses Calmont
France EHPAD Gai Logis Capdenac-Gare
France EHPAD La Croix Bleue Capdenac-gare
France EHPAD le bosc Carmaux Carmaux
France Tour Tottier Castelginest
France La Cerisaie Castelmaurou
France Notre Dame du Bon Accueil Castelnau-d´Estrétefonds
France M.R St Luc - Castelnau Montratier Castelnau-Montratier
France Chic Ehpad C.H Castelsarrasin
France EHPAD Villégiale Saint Jacques CHIC - CASTRES/MAZAMET Castres
France MAPA Résidence St Astier Catus
France EHPAD Caylus - Val de Bonnette Caylus
France EHPAD Arc-En-Ciel Cazals
France Jeanne Penent Cazères
France Castelgirou Cépet
France ALLIANCE Cologne
France EHPAD St Laurent Cruejouls
France EHPAD les arcades Dourgne
France EHPAD Saint-Philippe Ercé
France Saint-Joseph Fronton
France EHPAD St ANDRE CH de Gaillac Gaillac
France EHPAD St JEAN CH de Gaillac Gaillac
France EHPAD Accueil du Frère Jean Galan
France EHPAD La Baïse Galan
France Ch Gimont Gimont
France Foyer Pierre Bonhomme Gramat
France MR Charles de Gaulle Gramat
France MR Louis Conte Gramat
France EHPAD Saint Dominique Gramond
France Ehpad de Graulhet Graulhet
France Saint-Jacques Grenade
France Ste Sophie Grisolles
France EHPAD Résidence Zélia Ibos
France EHPAD Le Jonquère Juillan
France EHPAD Faux-Bourg Saint-Adrien L´ Isle-en-Dodon
France Saint-Jacques L´ Isle-Jourdain
France EHPAD Gustave Pédoya La Bastide-de-Sérou
France EHPADRouanet-Iché de LABASTIDE-ROUAIROUX Labastide-Rouairoux
France EHPADL'Oustal d'En Thibaud Labruguière
France M.R La Miséricorde Lacapelle-Marival
France EHPAD St vinçent de paul Lacaune
France Résidence du Lac Lafrançaise
France EHPAD résidence le grand champ Lagrave
France Les Causeries Laguépie
France Centre hospitalier du Pays d´Olmes - Laroques d´Olmes Laroques d´Olmes
France La Barbacane Larrazet
France MAPAD Les Ségalines Latronquière
France Résidence Paul et Lisa Launaguet
France Ehpad Les Quietudes Lautrec
France Centre hospitalier du Pays d´Olmes - Résidence du Touyre Lavelanet
France La Vendinelle Le Cabanial
France Ehpad Barrere Lectoure
France Ehpad Feral Lectoure
France Résidence Curtis Léguevin
France EHPAD L´Oasis Livinhac-le-Haut
France EHPAD La Madone Lourdes
France EHPAD Le Petit Jer Lourdes
France EHPAD Notre Dame des Grâces Lugan
France EHPAD Le Paginet Lunac
France MAPAD Les logis de l´Impernal Luzech
France EHPAD Le santoulis Luzenac
France EHPAD Saint Joseph Marcillac-Vallon
France Val de Gers Masseube
France EHPAD Le Clos du Raunier Mazères
France MR Beau Séjour Mercuès
France EHPAD du CH Millau - St Michel Millau
France EHPAD Les Charmettes Millau
France EHPAD Louise de Roquelaure Mirepoix
France EHPAD de MONESTIES Monestiés
France Ange Gardien Montauban
France Montauban - Ehpad Ushpa Montauban
France MR Saint Orens Montauban
France St Jean Marie Vianney Montbeton
France MR Sainte-Marie Montcuq
France M.R La Roseraie Montfaucon
France MR L´Etoile du Soir Montredon
France L´Hermitage Montréjeau
France EHPAD Rés. Parc de la Corette Mur-de-Barrez
France Le Barry Muret
France Résidence Marie-Antoinette Muret
France EHPAD Résidence les deux vallées Nant
France EHPAD Sainte Marie les Ursulines Nant
France EHPAD Résidence du Lac Orleix
France Centre Alzheimer Marie-Louise Pechbonnieu
France La Houlette Pibrac
France La Tranquilité Pins-Justaret
France Cité Saint Joseph Plaisance du Gers
France Le Prat Plaisance-du-Touch
France Oasis-Palmeraie Pointis-de-Rivière
France EHPAD La résidence du Lac Pont de Salars
France L´Auta Portet-sur-Garonne
France EHPAD Résidence du petit bois Pradines
France M.R Les balcons du Lot Prayssac
France M.R Les Lavandes Puy-l´Évêque
France EHPAD la Maison Du Lac Puygouzon
France Résidence Isatis Quint-Fonsegrives
France EHPAD Hermitage et Terrasses de Rabastens Rabastens
France EHPAD Jean Baptiste Delfau Requista
France EHPAD de Revel Revel
France EHPAD Les Rosiers Rignac
France Bel Adour Riscle
France EHPAD Bon Accueil Rodez
France EHPAD Julie Chauchard Rodez
France EHPAD Saint Cyrice Rodez
France EHPAD Saint Jacques du CH Rodez
France EHPAD Le clos de Siloe Roquecourbe
France EHPAD La Miséricorde Saint-Affrique
France Les Clos des Amandiers Saint-Alban
France Résidence de l´abbaye Saint-Antonin-Noble-Val
France Lavallée Saint-Clar
France EHPAD Les Galets d´Olt Saint-Côme-d´Olt
France L´Ensoleillade Saint-Gaudens
France Le Mas Saint-Pierre Saint-Gaudens
France EHPAD de l´Hôpital local Saint-Geniez-d´Olt
France Centre hospitalier Ariège Couserans Saint-Girons
France EHPAD Le Val d´Olt Saint-Laurent-d´Olt
France EHPAD Hector d´Ossun Saint-Lizier
France Les Rossignols Saint-Lys
France Maréchal Leclerc Saint-Lys
France Résidence La Joie de Vivre Saint-Lys
France EHPAD Clos St François Saint-Sernin-sur-Rance
France Ehpad Chez Nous Saint-Sulpice
France EHPAD Les grands chênes Saïx
France EHPAD Petite Plaisance SAVAGNAC Salvagnac
France EHPAD Vert Coteau Saverdun
France EHPAD Paul Ané Seix
France La Septfontoise Septfonds
France Ehpad Le Pre Fleuri Serviès
France EHPAD Sainte Marie Siradan
France EHPAD St Vinçent et Ste Croix Sorèze
France EHPAD St Jean St AMANS DES COTS
France Arc-en-Ciel Toulouse
France Caroline Baron Toulouse
France EHPAD Les Fontaines Toulouse
France La Cotonnière Toulouse
France La Pastellière Toulouse
France Les Tourelles Toulouse
France Maurice Garrigou Toulouse
France Orpéa Crampel Toulouse
France Plénitude Saint-Michel Toulouse
France Résidence Saint-Simon Toulouse
France Le Grand Marquisat Tournefeuille
France Ehpad Belcantou Trébas
France EHPAD Résidence Les Rives du Pélam Trie-sur-Baïse
France EHPAD du Centre Hospitalier Des Deux Rives Valence D Agen
France M.R Résidence Valpré Vayrac
France EHPAD ND de Touscayrats Verdalle
France MR Saint Jacques Verdun-sur-Garonne
France EHPAD La Clairière - Les Acacias Vic-en-Bigorre
France Ch Vic-Fezensac Vic-fezensac
France Le Château fleuri Vic-Fezensac
France EHPAD Sainte Claire Villefranche-de-Rouergue
France EHPAD Sud Rulhedu CH Villefranche-de-Rouergue
France Le Pin Villeneuve-Tolosane

Sponsors (2)

Lead Sponsor Collaborator
Agence Régionale de la Santé - Midi Pyrénées Observatoire Régional de la Santé Midi-Pyrénées (ORSMIP)

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Reduction in the prescription of psychotropic drugs from baseline to 18-month follow-up It will be examined if the rate of antidepressants, anxiolytics, antipsychotics, and hypnotics/sedatives (coded according to the Anatomical Therapeutic Chemical classification. Information available at: http://www.whocc.no/atc_ddd_index/) prescriptions will be reduced between baseline and follow-up. A particular attention will be given to the prevalence of people taking 3 or more psychotropics (increased risk of drug-drug interaction and adverse drug reaction) and to the use of these medications among people with dementia. baseline and 18-month follow-up No
Primary Change from baseline in nursing home quality indicators at 18 months Indicators of quality of care in 10 main outcomes: dementia (e.g.,prevalence of cognitive assessment), behavioural disturbances (e.g., prevalence of behavioural disturbances assessment), restraining (e.g., prevalence of restrained residents with a medical prescription for restraining), mood (e.g., prevalence of mood assessment), osteoporosis and falls (e.g., systematic analysis of fall records), nutrition (e.g., prevalence of residents who were weighed = 3 times in the last 3 months), pressure ulcers (e.g., prevalence of residents who were evaluated for the risk of pressure ulcers), pain (e.g., prevalence of residents who were evaluated for pain among residents in end-of-life), medication (e.g., prevalence of re-evaluation of residents' drug prescriptions among residents who take psychotropic), and care and services (e.g., prevalence of hospitalisations in the emergency department in the last 12 months). baseline and 18-month follow-up No
Secondary Onset of dependence in activities of daily living from baseline to 18 months follow-up Onset of dependence will be measured using the 6-item Katz ADL scale. Activities examined are: bathing, dressing, transferring, walking inside home, incontinence, and eating/drinking. Ability in executing each activity will be set as: "able to execute alone, without difficulty", "able to execute alone, with some difficulty", or "needing help to execute or unable to execute". baseline and 18-month follow-up No
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