Thursday, September 26, 2002

This presentation is part of : Posters

Maintaining Intervention Integrity in a Large Multi-site Longitudinal Design

Sandra Ferketich, PhD, dean1, Joyce Verran, PhD, professor2, and Linda Phillips, PhD, professor2. (1) College of Nursing, University of New Mexico, Albuquerque, NM, USA, (2) College of Nursing, University of Arizona, Tucsons, AZ, USA

This report is of management strategies for a large multisite, multi cultural and longitudinal study of a Community Health Nursing Model For Rural Hispanics funded by the Agency on Health Care Policy and Research for five years with an additional one-year no-cost extension.

Objective: The objective was to test three components of community health nursing in four rural communities on the outcomes of health status and health impact.

Design: Four rural communities were randomly assigned (without replacement) to the four treatments in this experimental design. The treatment protocols were to be maintained over site and time with appropriate modifications.

Population, Sample, Setting, Years: There were approximately 10,000 residents, 50% of whom were Hispanic and 50% non-Hispanic white. The outcome measure surveys were randomly assigned to different households, with a total 1,400 households across the communities. Three surveys were done over 5 years. These communities were in sparsely populated, underserved areas of Arizona. The communities were economically depressed and highly dependent upon copper mining. Local residents were employed for the intervention teams, local Public Health Department facilities were used and the Public Health Department was a subcontractor who hired and maintained the intervention staff. The study was conducted from 1990 to 1995 with an additional year for analysis, 1995-1996.

Concepts and Variables: Health care availability, accessibility, acceptability and affordability were concepts on which the treatment protocols were based. These protocols were to be implemented by teams of health care providers operating within the organization of the Public Health Department, which was a subcontractor on the grant. The length of the study and implementation protocols were to be carried out over 3 years in communities that were mostly Hispanic (50%) and white non-Hispanic (50%). Other ethnic groups were less than one percent. The sites required a drive from the research site that varied from 2 hours round trip to 6 hours round trip.

Methods: Two strategies were implemented in the management of this project. First, it was known that the multisite study would be difficult to manage given the distances were large and the teams and communities were disparate in their structure and health facilities. Thus, the team of researchers in Tucson was divided up in order to deal with specific components. These were the overall management, the intervention application and the data management. Second, the strength of the intervention had to be maintained over time while allowing for modifications as needed. Good documentation and attention to retaining subjects and intervention team members were planned.

Findings: While these strategies were planned and were necessary, they did not nearly cover the problems faced over the course of the study. A flood caused damage to approximately of one site with a loss of subjects from the site. The death of a key person in the Public Health Department, a geographic move of another and problems between one of the nurse team leaders and community members, problems between intervention staff on the same team and between teams were only some of the problems. Last but not least was the difficulty of attempting to experiment within an established bureaucratic structure. Constant change, attention to new dilemmas and the need for development and testing of new strategies were required. Unique strategies, each with its own time frame had to be used.

Conclusions: Researchers must pay constant attention to the interaction of the intervention teams and their members. The integrity of the experiment was maintained but required Organizational development both of the large intervention team and the large research team. Local feuds had to be mediated. Organization change was necessary to maintain the integrity of the experiment in spite of the negative influence of a relatively inflexible bureaucratic health care system. Although it was not possible to know ahead of time, old feuds in the small towns entered into interaction of team members. These had to be dealt with both individually and within the group(s). Additional personnel, budget expenditures, and time had to be planned to accommodate to these problems.

Implications: The need for attention to these details, loss of personnel, changeover in personnel and natural forces in a community experiment must be taken into account. Without adequate time, the investigators will quickly find themselves burdened with these activities and the integrity of the experiment can come into question. The co-principal investigators on the project had a combined research background of over 30 years. They were, however, challenged and needed every bit of expertise to maintain the experiment.

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