Effectiveness of Implementing the Adapted Practice Guidelines for Primary Care of Acute Abdomen in Zambia: An Effectiveness-Implementation Hybrid Type 2 Study Design.

The study aims 1) to adapt, 2) to develop implementation strategies for and 3) to evaluate the effect of implementing a practice guideline for acute abdomen at primary care level in Zambia. We employ a sequential exploratory mixed method study design. Qualitative and quantitative data from health care workers will be used to adapt a practice guideline developed in a high-income into a low- and middle-income (LMIC) context and to develop strategies for successful implementation. The primary outcome of interest is the prospective change in length of stay in hospital among patients presenting with acute abdomen in the intervention site compared to the control site. The study will address the scarcity of literature on practice guidelines for acute abdomen in the LMIC context. The implementation of an adapted guideline may contribute to a reduction of the morbidity and mortality rates associated with acute abdomen in this setting by increasing management capacity at the primary care level.

Study Overview

• Status: Recruiting
• Conditions: Practice Guidelines for Primary Care of Acute Abdomen
• Intervention / Treatment: Other: Practice guidelines for primary care of acute abdomen; Other: No intervention

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wilson Mbewe, MD; Phone Number: +260977466316; Email: wimbe8573@uib.no

Study Locations

• Zambia
  • Lusaka Province
    • Lusaka, Lusaka Province, Zambia, 10101
      • Recruiting
      • Kanyama First Level Hospital and Matero First Level Hospital
      • Contact: Nalukuyi Wanga; Phone Number: +26097503805; Email: nalu07@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Data from all patients 18 year and older with acute abdomen including surgical, gynecological and medical acute abdomen managed at the intervention site and control site will be collected during the study period.

Exclusion Criteria:

• All cases of acute abdomen secondary to trauma will be excluded from the study. All patients in the immediate postoperative phase operated from other facilities presenting with acute abdomen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention site; The intervention site will have the guidelines for acute abdomen implemented	Other: Practice guidelines for primary care of acute abdomen; Adjusted practice guidelines for primary care of acute abdomen will be implemented at the intervention site.
Active Comparator: Control site; The control site will not have the guidelines implemented	Other: No intervention; The control site will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	The duration of time in days that a patient with acute abdomen stays in the hospital from the day of admission to discharge	7 days

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: University of Zambia
• Investigators: Study Director: Elisabeth Marie Strømme, MD, PhD, University of Bergen; Study Director: Thomas Mildestvedt, MD, PhD, University of Bergen; Study Director: Eivind Meland, University of Bergen; Study Director: Mpundu Makasa, University of Zambia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Acute Abdomen, Practice guidelines, Primary Health Care, Adaptation, Implementation Strategies, Effectiveness-Implementation Hybrid Type 2 Study Design
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abdomen, Acute; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Guidelines as Topic; Quality Assurance, Health Care; Practice Guidelines as Topic
• Other Study ID Numbers: REK Ref No: 576758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No